- What’s the story with Fosamax?
- What’s the evidence?
- Now what?
- What can you do?
- SIDE EFFECTS
- Clinical Trials Experience
- Treatment Of Osteoporosis In Postmenopausal Women
- Prevention Of Osteoporosis In Postmenopausal Women
- Osteoporosis In Men
- Glucocorticoid-Induced Osteoporosis
- Paget’s Disease Of Bone
- Post-Marketing Experience
- Reduce Your Risk
- How the Medication Works
- What Should a Patient Do?
- SIDE EFFECTS
- What is Fosamax?
- Important information
- Before taking this medicine
- How should I take Fosamax?
- What happens if I miss a dose?
- What happens if I overdose?
- What should I avoid while taking Fosamax?
- Fosamax side effects
- What other drugs will affect Fosamax?
- Further information
- More about Fosamax (alendronate)
- What is Alendronate (Fosamax®)?
- How do I take it?
- What else should I know?
- What about other medications?
- Fosamax Side Effects
- Fosamax® and Osteonecrosis of the Jaw – Some New and Frequently Asked Questions
- 1. According to the experts, what is the incidence of osteonecrosis of the jaw in Fosamax users?
- 2. What numbers can I use to tell the dental patient their risk of developing ONJ with Fosamax?
- 3. Is the risk of acquiring osteonecrosis of the jaw bone diminished with the use of other oral bisphosphonates, compared to Fosamax?
- 4. Will Fosamax or the other oral bisphosphonates continue to be the standard treatment for osteoporosis?
- 5. Do we know how the jaw bone becomes necrotic from Fosamax?
- 6. What are the factors that increase the risk of jaw bone necrosis in Fosamax users?
- 7. What are the symptoms that a Fosamax patient would experience which could indicate necrotic jaw bone?
- 8. What kind of dental procedures can be performed in Fosamax users with no increase in risk for ONJ?
- 9. Is dento-alveolar surgery contraindicated in Fosamax users?
- 10. Is a so-called “drug holiday” an effective way to reduce the risks of ONJ in Fosamax users prior to dental-alveolar surgery?
- 11. In patients about to begin oral bisphosphonate therapy, should the bisphosphonate be delayed until dental health is optimized?
- 12. Is diagnostic imaging useful in assessing those bisphosphonate individuals at risk for ONJ?
- alendronate (Binosto, Fosamax)
- How does this medication work? What will it do for me?
- What form(s) does this medication come in?
- How should I use this medication?
- Who should NOT take this medication?
- What side effects are possible with this medication?
- Are there any other precautions or warnings for this medication?
- What other drugs could interact with this medication?
What’s the story with Fosamax?
Published: November, 2008
Recent reports have women wondering if they should stop taking this widely prescribed osteoporosis drug.
In 1995, the FDA approved alendronate (Fosamax) for the treatment of postmenopausal osteoporosis, a bone-weakening condition that affects more than eight million women and causes 1.5 million fractures each year in the United States. Fosamax increases bone mineral density and significantly reduces the risk of spine, hip, and wrist fractures in women with osteoporosis and in those with low bone density that doesn’t meet the criteria for osteoporosis (a condition called osteopenia).
Fractures are an important cause of disability and death in postmenopausal women. Hip fractures lead to hospitalization and, usually, surgery — and they often result in nursing home care. Only 40% of hip fracture patients ever regain their independence, and nearly 25% die within a year. Vertebral fractures can cause debilitating back pain, and they, too, increase the risk of premature death.
Fosamax belongs to a class of drugs called bisphosphonates, which work by slowing resorption, the breakdown phase of normal bone remodeling. Fosamax is the oldest of these drugs and has been used the most and studied the longest. We know, for example, that it improves bone density for at least 10 years. Most patients tolerate Fosamax well; its most common side effects are irritation of the esophagus and stomach ulcer.
In the past few years, reports have emerged linking bisphosphonates with osteonecrosis (bone death) of the jaw and atrial fibrillation. With respect to Fosamax, those concerns have largely been allayed: users rarely develop osteonecrosis of the jaw, and the evidence for a relationship with heart rhythm problems is conflicting. But now, new concerns have been raised by reports of unusual fractures of the thighbone (femur) in long-term Fosamax users. There are no evidence-based guidelines on how long patients can or should take Fosamax, but some women and their physicians are considering a drug holiday. Many of our own readers have written, asking if they should stop taking the drug.
What’s the evidence?
In 2008, researchers in Singapore published a report on 17 postmenopausal women, average age 66, who experienced fractures across the thighbone unprovoked by major trauma. All of the women had been taking Fosamax for an average of five years, and 13 of them had leg pain before the fracture developed. The researchers reported similar findings in a smaller study in 2007; they theorized that prolonged suppression of bone remodeling by Fosamax may have encouraged fracture-inducing microdamage to the bone.
Prompted by the Singapore findings, clinicians at New York’s Hospital for Special Surgery identified 70 patients who had suffered low-energy fractures between 2002 and 2007. (Low-energy fractures occur from a fall from standing height or less.) Twenty-five (36%) had been taking Fosamax. Of these, 20 had suffered a fracture across the femur, and 19 of those fractures occurred in patients who had been taking Fosamax the longest — on average, seven years. The researchers concluded that long-term Fosamax use is a significant risk factor for low-energy fractures of the femur.
The initial reports also drew letters to the editor of The New England Journal of Medicine, including evidence both supporting and refuting a link between bisphosphonates and nontraumatic fractures. The studies thus far have been small, retrospective analyses, and they haven’t taken into account other factors that could contribute to such fractures, including general ill health. But given what we know about the effects of bisphosphonates on bone remodeling, the findings seem plausible.
In the short term, slowing bone resorption increases bone density. But in the long run, it may impair new bone formation and reduce the bone’s ability to repair microscopic cracks from normal wear and tear. (There’s some evidence in animal studies that Fosamax can inhibit microdamage repair.) Over time, such microdamage might accumulate and cause a fracture. Also, while bone breakdown is suppressed, the mineralization process continues, potentially resulting in “hypermineralized” bone, which may be more brittle and less resilient to wear and tear. This is all largely speculative, as no studies have produced empirical evidence that such mechanisms actually lead to fractures.
Merck, the manufacturer of Fosamax, says it will undertake further study of the drug’s effects on bone. And the FDA and Merck will continue monitoring for adverse events. In the meantime, it’s important not to overreact. Fosamax has a proven capacity to prevent fractures — and the disability and death that can accompany them. By 2010, according to the National Osteoporosis Foundation (NOF), as many as 12 million Americans will have osteoporosis, and over 40 million will have osteopenia (low bone mass). Most experts believe that when Fosamax is used appropriately, its benefits greatly outweigh the risks.
Clinicians diagnose osteoporosis by measuring bone mineral density with a technique known as dual-energy x-ray absorptiometry (DXA). DXA results are used to calculate a statistical measure called a T-score. Experts recommend that a woman with osteoporosis (defined by a T-score of –2.5 or below) should strongly consider drug treatment to reduce her fracture risk.
Women with osteopenia — a T-score between –1.0 and –2.5 — should consider other risk factors before deciding about drug therapy. The World Health Organization has developed the Fracture Risk Assessment Tool (FRAX), an online calculator that estimates an individual’s 10-year risk of having a hip fracture or other major fracture (available at www.nof.org and www.shef.ac.uk/FRAX). The NOF suggests that a woman with osteopenia should consider drug treatment if the FRAX calculator says that her 10-year risk for a hip fracture is at least 3% — or her 10-year risk for any major fracture is at least 20%.
Currently, there’s no consensus on how long you should take a bisphosphonate medication. Until we know more, women taking Fosamax who have severe osteoporosis or a prior fracture should probably continue doing so indefinitely. But results from the Fracture Intervention Trial Long-term Extension (FLEX) study published in 2006 suggest that some women can eventually stop or take a break. In that study, women who had taken Fosamax for at least five years were randomly assigned to continue the drug or switch to a placebo for five more years. Those who discontinued Fosamax (the placebo takers) showed a gradual decline in bone density and a slight increase in the risk for spine fractures, but the rate of hip fracture, a far more serious injury, was the same in the two groups. (Women with severe osteoporosis — a T-score below –3.5 — were excluded from the study.)
What can you do?
As with any drug, don’t take Fosamax unless you’re sure you need to. If you’ve been taking it and are concerned about long-term effects, talk to your clinician about taking a break. Unfortunately, we have little solid evidence to guide us in this area. We know that bisphosphonates stay in bone for years, so it’s not clear that a “drug holiday” will lower your risk for possible long-term effects. If you decide to take a break, be sure to have your bone density tested after a year or two. If it has declined significantly, you can always resume bisphosphonate therapy.
Meanwhile, continue all the other measures that help protect and maintain bone density: take 1,200 to 1,500 milligrams of calcium and 800 IU of vitamin D every day; get 30 minutes of weight-bearing exercise at least three times a week; and if you smoke, do your best to stop.
As a service to our readers, Harvard Health Publishing provides access to our library of archived content. Please note the date of last review on all articles. No content on this site, regardless of date, should ever be used as a substitute for direct medical advice from your doctor or other qualified clinician.
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
Treatment Of Osteoporosis In Postmenopausal Women
The safety of FOSAMAX in the treatment of postmenopausal osteoporosis was assessed in four clinical trials that enrolled 7453 women aged 44-84 years. Study 1 and Study 2 were identically designed, three-year, placebo-controlled, double-blind, multicenter studies (United States and Multinational n=994); Study 3 was the three-year vertebral fracture cohort of the Fracture Intervention Trial (n=2027) and Study 4 was the four-year clinical fracture cohort of FIT (n=4432). Overall, 3620 patients were exposed to placebo and 3432 patients exposed to FOSAMAX. Patients with preexisting gastrointestinal disease and concomitant use of non-steroidal anti-inflammatory drugs were included in these clinical trials. In Study 1 and Study 2 all women received 500 mg elemental calcium as carbonate. In Study 3 and Study 4 all women with dietary calcium intake less than 1000 mg per day received 500 mg calcium and 250 international units Vitamin D per day.
Among patients treated with alendronate 10 mg or placebo in Study 1 and Study 2, and all patients in Study 3 and Study 4, the incidence of all-cause mortality was 1.8% in the placebo group and 1.8% in the FOSAMAX group. The incidence of serious adverse event was 30.7% in the placebo group and 30.9% in the FOSAMAX group. The percentage of patients who discontinued the study due to any clinical adverse event was 9.5% in the placebo group and 8.9% in the FOSAMAX group. Adverse reactions from these studies considered by the investigators as possibly, probably, or definitely drug related in greater than or equal to 1% of patients treated with either FOSAMAX or placebo are presented in Table 1.
Table 1: Osteoporosis Treatment Studies in Postmenopausal Women Adverse Reactions Considered Possibly, Probably, or Definitely Drug Related by the Investigators and Reported in Greater Than or Equal to 1% of Patients
Rash and erythema have occurred.
Gastrointestinal Adverse Reactions: One patient treated with FOSAMAX (10 mg/day), who had a history of peptic ulcer disease and gastrectomy and who was taking concomitant aspirin, developed an anastomotic ulcer with mild hemorrhage, which was considered drug related. Aspirin and FOSAMAX were discontinued and the patient recovered. In the Study 1 and Study 2 populations, 49-54% had a history of gastrointestinal disorders at baseline and 54-89% used nonsteroidal anti-inflammatory drugs or aspirin at some time during the studies.
Laboratory Test Findings: In double-blind, multicenter, controlled studies, asymptomatic, mild, and transient decreases in serum calcium and phosphate were observed in approximately 18% and 10%, respectively, of patients taking FOSAMAX versus approximately 12% and 3% of those taking placebo. However, the incidences of decreases in serum calcium to less than 8.0 mg/dL (2.0 mM) and serum phosphate to less than or equal to 2.0 mg/dL (0.65 mM) were similar in both treatment groups.
The safety of FOSAMAX 70 mg once weekly for the treatment of postmenopausal osteoporosis was assessed in a one-year, double-blind, multicenter study comparing FOSAMAX 70 mg once weekly and FOSAMAX 10 mg daily. The overall safety and tolerability profiles of once weekly FOSAMAX 70 mg and FOSAMAX 10 mg daily were similar. The adverse reactions considered by the investigators as possibly, probably, or definitely drug related in greater than or equal to 1% of patients in either treatment group are presented in Table 2.
Table 2: Osteoporosis Treatment Studies in Postmenopausal Women Adverse Reactions Considered Possibly, Probably, or Definitely Drug Related by the Investigators and Reported in Greater Than or Equal to 1% of Patients
Prevention Of Osteoporosis In Postmenopausal Women
The safety of FOSAMAX 5 mg/day in postmenopausal women 40-60 years of age has been evaluated in three double-blind, placebo-controlled studies involving over 1,400 patients randomized to receive FOSAMAX for either two or three years. In these studies the overall safety profiles of FOSAMAX 5 mg/day and placebo were similar. Discontinuation of therapy due to any clinical adverse event occurred in 7.5% of 642 patients treated with FOSAMAX 5 mg/day and 5.7% of 648 patients treated with placebo.
The safety of FOSAMAX 35 mg once weekly compared to FOSAMAX 5 mg daily was evaluated in a one-year, double-blind, multicenter study of 723 patients. The overall safety and tolerability profiles of once weekly FOSAMAX 35 mg and FOSAMAX 5 mg daily were similar.
The adverse reactions from these studies considered by the investigators as possibly, probably, or definitely drug related in greater than or equal to 1% of patients treated with either once weekly FOSAMAX 35 mg, FOSAMAX 5 mg/day or placebo are presented in Table 3.
Table 3: Osteoporosis Prevention Studies in Postmenopausal Women Adverse Reactions Considered Possibly, Probably, or Definitely Drug Related by the Investigators and Reported in Greater Than or Equal to 1% of Patients
Concomitant Use With Estrogen/Hormone Replacement Therapy
In two studies (of one and two years’ duration) of postmenopausal osteoporotic women (total: n=853), the safety and tolerability profile of combined treatment with FOSAMAX 10 mg once daily and estrogen ± progestin (n=354) was consistent with those of the individual treatments.
Osteoporosis In Men
In two placebo-controlled, double-blind, multicenter studies in men (a two-year study of FOSAMAX 10 mg/day and a one-year study of once weekly FOSAMAX 70 mg) the rates of discontinuation of therapy due to any clinical adverse event were 2.7% for FOSAMAX 10 mg/day vs. 10.5% for placebo, and 6.4% for once weekly FOSAMAX 70 mg vs. 8.6% for placebo. The adverse reactions considered by the investigators as possibly, probably, or definitely drug related in greater than or equal to 2% of patients treated with either FOSAMAX or placebo are presented in Table 4.
Table 4: Osteoporosis Studies in Men Adverse Reactions Considered Possibly, Probably, or Definitely Drug Related by the Investigators and Reported in Greater Than or Equal to 2% of Patients
In two, one-year, placebo-controlled, double-blind, multicenter studies in patients receiving glucocorticoid treatment, the overall safety and tolerability profiles of FOSAMAX 5 and 10 mg/day were generally similar to that of placebo. The adverse reactions considered by the investigators as possibly, probably, or definitely drug related in greater than or equal to 1% of patients treated with either FOSAMAX 5 or 10 mg/day or placebo are presented in Table 5.
Table 5: One-Year Studies in Glucocorticoid-Treated Patients Adverse Reactions Considered Possibly, Probably, or Definitely Drug Related by the Investigators and Reported in Greater Than or Equal to 1% of Patients
The overall safety and tolerability profile in the glucocorticoid-induced osteoporosis population that continued therapy for the second year of the studies (FOSAMAX: n=147) was consistent with that observed in the first year.
Paget’s Disease Of Bone
In clinical studies (osteoporosis and Paget’s disease), adverse events reported in 175 patients taking FOSAMAX 40 mg/day for 3-12 months were similar to those in postmenopausal women treated with FOSAMAX 10 mg/day. However, there was an apparent increased incidence of upper gastrointestinal adverse reactions in patients taking FOSAMAX 40 mg/day (17.7% FOSAMAX vs. 10.2% placebo). One case of esophagitis and two cases of gastritis resulted in discontinuation of treatment.
Additionally, musculoskeletal (bone, muscle or joint) pain, which has been described in patients with Paget’s disease treated with other bisphosphonates, was considered by the investigators as possibly, probably, or definitely drug related in approximately 6% of patients treated with FOSAMAX 40 mg/day versus approximately 1% of patients treated with placebo, but rarely resulted in discontinuation of therapy. Discontinuation of therapy due to any clinical adverse events occurred in 6.4% of patients with Paget’s disease treated with FOSAMAX 40 mg/day and 2.4% of patients treated with placebo.
The following adverse reactions have been identified during post-approval use of FOSAMAX. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Body as a Whole: hypersensitivity reactions including urticaria and angioedema. Transient symptoms of myalgia, malaise, asthenia and fever have been reported with FOSAMAX, typically in association with initiation of treatment. Symptomatic hypocalcemia has occurred, generally in association with predisposing conditions. Peripheral edema.
Gastrointestinal: esophagitis, esophageal erosions, esophageal ulcers, esophageal stricture or perforation, and oropharyngeal ulceration. Gastric or duodenal ulcers, some severe and with complications, have also been reported .
Localized osteonecrosis of the jaw, generally associated with tooth extraction and/or local infection with delayed healing, has been reported .
Musculoskeletal: bone, joint, and/or muscle pain, occasionally severe, and incapacitating ; joint swelling; low-energy femoral shaft and subtrochanteric fractures .
Nervous System: dizziness and vertigo.
Pulmonary: acute asthma exacerbations.
Skin: rash (occasionally with photosensitivity), pruritus, alopecia, severe skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis.
Special Senses: uveitis, scleritis or episcleritis. Cholesteatoma of the external auditory canal (focal osteonecrosis).
Read the entire FDA prescribing information for Fosamax (Alendronate Sodium)
May 10, 2012 — The U.S. Food and Drug Administration says doctors need to reassess which women are likely to benefit from popular bone-building drugs, given the lack of evidence showing that taking them for the long term really helps and the possibility that they put some women at risk for rare but serious side effects.
In a report published in the New England Journal of Medicine on Wednesday, the U.S. Food and Drug Administration raised concerns about the potential for some serious side effects in women taking bone-building drugs called bisphosphonates, specifically Fosamax, Actonel and Reclast.
The published findings are not new. In 2011, the agency voiced concerns that taking the drugs long-term may actually make bones weaker and increase the risk of rare but serious side effects such as atypical fractures of the thigh bone, esophageal cancer and osteonecrosis of the jaw, a rare but painful condition in which the jaw bone crumbles. To investigate, the FDA reviewed data from women who had taken the drugs for six to 10 years.
In Wednesday’s report, the agency repeated its 2011 conclusions: Women without osteoporosis seem to get few to no benefits to their bones from taking the drugs beyond five years. In light of the concerns about the potential side effects, the authors said some patients should be able to safely stop taking the drugs after that time, particularly if they are younger and at low risk of fractures.
They suggested that women who continue to have very low bone density, measured by a “T score” lower than minus 2.5, are the ones who may benefit the most from taking the drugs after five years.
A commentary accompanying the FDA’s report said it is older women who have a history of fractures or are at an increased fracture risk, particularly of spine fractures, who stand to benefit from taking the drugs for longer than five years.
Dennis Black, a professor of epidemiology at the University of California, San Francisco and the lead author of the commentary, said the drugs appear to be safe and helpful for women taking them for a just few years at a time.
“These drugs in general have very strong proven benefits for the first five years,” Black said. “I would want a patient with osteoporosis to not let the worry about these very rare side effects overwhelm the very strong benefits they would get.”
The reports reflect overall uncertainty about the optimal length of time a patient should take these drugs. Clinical trials of bisphosphonates have studied large numbers of women for up to five years and have shown that the drugs are effective for that length of time. But the trials looking at the effects after five years have included a much smaller number of patients, meaning their results are less certain.
“The problem is we don’t really know when to start or stop these drugs, and we don’t know how common those serious adverse events are,” said Dr. Rita Redberg, a professor of medicine at UCSF. “We think they’re uncommon, but we don’t really have strong data.”
According to the FDA, doctors wrote more than 150 million prescriptions for bisphosphonates between 2005 and 2009. The drugs work by targeting the body’s process of breaking down and regenerating bone cells. After age 30 or so, a woman’s bones start to break down faster than the body can rebuild them, which can lead to the brittle, vulnerable bones of osteoporosis. The drugs work to slow down the bone-dissolving process, letting the cells that work to build bone mass catch up.
The drugs are incorporated into the newly formed bone and can stay there for years, even after a woman stops taking them.
It’s not clear how many women are affected by the FDA’s recommendations, but the researchers estimated that as many as 70 percent of women currently taking bisphosphonates could be candidates for stopping the drugs after five years. A number of women stop taking the drugs after only one or two years anyway, because of several inconvenient aspects of the prescriptions, such as needing to remain upright for several hours after taking the drug.
Doctors emphasize that the risk of atypical fractures associated with bisphosphonates is very low and appears to account for less than 1 percent of leg and hip fractures overall. Dr. Beatrice Edwards, an associate professor of orthopedic surgery at the Northwestern University Feinberg School of Medicine, said she thinks the drugs are generally safe for as long as five years, but still keeps a close eye on her patients who take them.
“We usually have a discussion about the benefits and risks and look at their bone density,” Edwards said. “We may give them a five-year treatment, and then take them off for one or two years.”
The FDA’s report said additional research is needed before doctors can determine if interruption of treatments is helpful.
For now, the FDA and other experts say women should be mindful of how long they have been taking the drugs and talk to their doctors about whether continuing to use the drugs is best for them. The FDA already placed a statement on the drugs’ labels saying patients should be reevaluated periodically.
For patients at low risk of osteoporosis, experts recommend regular exercise and diets rich in calcium and vitamin D for staving off the disease.
ABC News’ Dr. C. Michael Minder contributed to this report.
Reduce Your Risk
A number of factors put both men and women at risk for osteoporosis, including age, race, family history, and a sedentary lifestyle. But there are also several ways you can reduce that risk, including:
- getting adequate amounts of calcium and Vitamin D through foods
- staying physically active, including weight-bearing exercise such as walking, jogging, skipping rope, and skiing
- not smoking
- limiting alcohol use
Researchers at the Food and Drug Administration (FDA) have taken a close look at the long-term benefit of bisphosphonates, a class of medications widely prescribed to treat osteoporosis.
An FDA review of clinical studies measuring the effectiveness of long-term bisphosphonates use shows that some patients may be able to stop using bisphosphonates after three to five years and still continue to benefit from their use, says Marcea Whitaker, M.D., a medical officer at FDA’s Center for Drug Evaluation and Research. Whitaker is one of the co-authors of the FDA review, which was published in the May 31, 2012 issue of The New England Journal of Medicine.
If you’re one of the 44 million Americans at risk for osteoporosis—a disease in which bones become weak and are more likely to break—you may be taking bisphosphonates. This class of drugs has been successfully used since 1995 to slow or inhibit the loss of bone mass. Doctors commonly prescribe such brand-name drugs as Actonel, Atelvia, Boniva, and Fosamax (as well as a number of generic products) for osteoporosis. In fact, more than 150 million prescriptions were dispensed to patients between 2005 and 2009.
According to the review, further investigation is needed on the long-term risks and benefits of these drugs.
“These drugs clearly work,” Whitaker says. “We just don’t know yet the optimum period of time individual patients should be on the drug to both maximize its effectiveness and minimize potential risks.” More research is needed on patients’ risk of fracture after they stop taking bisphosphonates, and whether taking them again later on could prove beneficial, she adds. As always, patients should talk to their health care provider about their continued need for therapy.
The studies suggest that patients at low risk of fracture (for example, younger patients without a fracture history and with a bone mineral density approaching normal) may be good candidates for discontinuation of bisphosphonate therapy after three to five years.
In contrast, patients at increased risk for fractures (for example, older patients with a history of fracture and a bone mineral density remaining in the osteoporotic range) may benefit further from continued bisphosphonate therapy.
How the Medication Works
Bones go through a continual process of remodeling, in the form of bone resorption (disintegration) and bone formation. Bone loss related to osteoporosis occurs when resorption is greater than formation. Bisphosphonates decrease bone resorption, thereby slowing bone loss.
During treatment, bisphosphonates become part of the newly formed bone and can stay there for years, through many cycles of resorption and formation. Patients continue to be exposed to the effects of the drug even long after they’ve stopped taking it.
According to Whitaker, the studies that FDA considered focused on patients who had been using bisphosphonates for at least three years and as many as 10. They looked at outcomes related both to bone mineral density and bone fractures.
“Bisphosphonates have been proven very effective in protecting against bone fractures in clinical trials lasting three to four years,” says Whitaker. But it’s still unknown whether the benefit lasts longer than that in decreasing the risk of fractures.
Bisphosphonate labels have carried a safety warning about severe jaw bone decay (osteonecrosis of the jaw) since 2002. In October 2010, FDA warned patients and health care professionals about the increased risk of unusual thigh bone fractures and directed manufacturers to include the warning in the safety labels and medication guides that come with prescription medications. FDA continues to evaluate the possible association of bisphosphonates with esophageal cancer. These associations would suggest that health care professionals may want to reconsider how long patients should continue taking the drugs.
What Should a Patient Do?
Decisions to continue treatment must be based on individual assessments of risks and benefits and on patient preference, Whitaker says
If you are taking bisphosphonates:
- Talk to your physician about whether or not you should continue this therapy. Re-evaluate the decision on a periodic basis.
- Don’t stop taking these (or any) prescribed drugs without talking to your physician first. If you do make the decision to discontinue use, talk to your physician before stopping therapy.
- Tell your health care professional if you develop new hip or thigh pain (commonly described as dull or aching pain), or have any concerns with your medications.
- Report unusual side effects of your bisphosphonate medication to FDA’s MedWatch program.
Generic Name: alendronate (a LEN dro nate)
Brand Names: Binosto, Fosamax
Medically reviewed by Kaci Durbin, MD Last updated on Feb 7, 2019.
- Side Effects
What is Fosamax?
Fosamax (alendronate) is a bisphosphonate (bis FOS fo nayt) medicine that alters bone formation and breakdown in the body. This can slow bone loss and may help prevent bone fractures.
Fosamax is used in women to treat or prevent osteoporosis caused by menopause and in men and women to treat osteoporosis caused by taking steroids.
Fosamax is also used to increase bone mass in men who have osteoporosis, and to treat Paget’s disease of bone in men and women.
You should not take Fosamax if you have problems with your esophagus, or low levels of calcium in your blood.
Do not take Fosamax if you cannot sit upright or stand for at least 30 minutes after taking the medicine.
Fosamax can cause serious problems in the stomach or esophagus. Stop using this medicine and call your doctor at once if you have chest pain, new or worsening heartburn, or pain when swallowing.
In rare cases, this medicine may cause bone loss (osteonecrosis) in the jaw or a broken leg bone called a femur fracture. Symptoms of osteonecrosis include jaw pain or numbness, red or swollen gums, loose teeth, or slow healing after dental work. Symptoms of a femur fracture include leg or groin pain.
Also call your doctor if you have muscle spasms, numbness or tingling (in hands and feet or around the mouth), new or unusual hip pain, or severe pain in your joints, bones, or muscles.
Before taking this medicine
You should not take Fosamax if you are allergic to alendronate, or if you have:
low levels of calcium in your blood (hypocalcemia); or
problems with the muscles in your esophagus (the tube that connects your mouth and stomach).
Do not take Fosamax if you cannot sit upright or stand for at least 30 minutes. Fosamax can cause serious problems in the stomach or esophagus. You must stay upright for at least 30 minutes after taking this medicine.
To make sure this medicine is safe for you, tell your doctor if you have ever had:
problems with your stomach or digestion;
low levels of calcium in your blood;
a dental problem (you may need a dental exam before you begin taking Fosamax);
kidney disease; or
any condition that makes it hard for your body to absorb nutrients from food (malabsorption).
In rare cases, this medicine may cause bone loss (osteonecrosis) in the jaw. Symptoms include jaw pain or numbness, red or swollen gums, loose teeth, or slow healing after dental work. The longer you use Fosamax, the more likely you are to develop this condition.
Osteonecrosis of the jaw may be more likely if you have cancer or received chemotherapy, radiation, or steroids. Other risk factors include blood clotting disorders, anemia (low red blood cells), and a pre-existing dental problem.
Fosamax has also been reported to cause fractures, or broken bones, in the large bones of the leg. Tell your doctor if you have any leg or groin pain while using Fosamax.
Talk with your doctor about the risks and benefits of using this medication.
It is not known whether Fosamax will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant. Stop using the medicine and tell your doctor right away if you become pregnant.
It is not known whether alendronate passes into breast milk or if it could harm a nursing baby. Ask your doctor about any risk.
How should I take Fosamax?
Take Fosamax exactly as prescribed by your doctor. Fosamax is taken either once daily or once per week. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.
Take Fosamax first thing in the morning, at least 30 minutes before you eat or drink anything or take any other medicine. If you take this medicine only once per week, take it on the same day each week and always first thing in the morning.
Take with a full glass (6 to 8 ounces) of plain water. Do not use coffee, tea, soda, juice, or mineral water. Do not eat or drink anything other than plain water.
Do not crush, chew, or suck on an Fosamax tablet. Swallow the tablet whole.
For at least 30 minutes after taking Fosamax:
Do not lie down or recline.
Do not take any other medicine including vitamins, calcium, or antacids.
Pay special attention to your dental hygiene while taking Fosamax. Brush and floss your teeth regularly. If you need to have any dental work (especially surgery), tell the dentist ahead of time that you are using alendronate.
Fosamax is only part of a complete program of treatment that may also include diet changes, exercise, bone mineral density testing, and taking calcium and vitamin supplements. Follow your doctor’s instructions very closely.
Store at room temperature away from moisture and heat.
Your doctor will determine how long to treat you with this medicine. Fosamax is often given for only 3 to 5 years.
What happens if I miss a dose?
Once-daily dosing: If you forget to take Fosamax first thing in the morning, do not take it later in the day. Wait until the following morning and skip the missed dose. Do not take two (2) doses in one day.
Once-per-week dosing: If you forget to take Fosamax on your scheduled day, take it first thing in the morning on the day after you remember the missed dose. Then return to your regular weekly schedule on your chosen dose day. Do not take 2 doses in one day.
What happens if I overdose?
Drink a full glass of milk and seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Do not make yourself vomit and do not lie down.
What should I avoid while taking Fosamax?
Avoid taking any other medicines for at least 30 minutes after taking Fosamax. This includes vitamins, calcium, and antacids. Some medicines can make it harder for your body to absorb alendronate.
Avoid smoking, or try to quit. Smoking can reduce your bone mineral density, making fractures more likely.
Avoid drinking large amounts of alcohol. Heavy drinking can also cause bone loss.
Fosamax side effects
Get emergency medical help if you have signs of an allergic reaction to Fosamax: hives; wheezing, difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop using Fosamax and call your doctor at once if you have:
chest pain, new or worsening heartburn;
difficulty or pain when swallowing;
pain or burning under the ribs or in the back;
severe heartburn, burning pain in your upper stomach, or coughing up blood;
new or unusual pain in your thigh, hip or groin;
jaw pain, numbness, or swelling;
severe joint, bone, or muscle pain; or
signs of low calcium levels – muscle spasms or contractions, numbness or tingly feeling (around your mouth, or in your fingers and toes).
Common Fosamax side effects may include:
heartburn, upset stomach;
stomach pain, nausea;
diarrhea, constipation; or
bone pain, muscle or joint pain.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What other drugs will affect Fosamax?
Tell your doctor about all your current medicines and any you start or stop using, especially:
This list is not complete. Other drugs may interact with alendronate, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide. Talk with your doctor about the best dosing schedule for your other medicines.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Fosamax only for the indication prescribed.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
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- Prevention of Osteoporosis
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What is Alendronate (Fosamax®)?
Alendronate is commonly known by the brand name Fosamax®. Fosamax® is a bisphosphonate and is used in the treatment of osteoporosis. Fosamax® decreases the rate bone cells are absorbed. This reduced absorption allows the body to increase bone density, which in turn reduces the risk of fracture.
How do I take it?
Fosamax® is taken once weekly or once daily. The pills are available in 5 mg, 10mg, 35 mg, 40 mg, and 70 mg strength. The usual dosage for osteoporosis prevention is 35 mg once weekly, or 5 mg once daily. The usual dosage for osteoporosis treatment is 70 mg once weekly, or 10 mg once daily. You doctor will tell you how many pills to take and how often. Follow your doctor’s directions. For the best results, take these pills at the same time every day. Take it on an empty stomach with a full glass of water, at least two hours after, or a full half hour before eating. Do not take it in combination with other medications or any vitamin or food supplements. DO NOT LIE DOWN FOR A FULL HALF HOUR TO REDUCE THE RISK OF UNWANTED SIDE EFFECTS.
What else should I know?
Fosamax® may cause irritation or ulceration of the esophagus, however, this is very unlikely if you are able to stand or sit upright for at least 30 minutes after taking the medication. Individuals with untreated calcium deficiency or esophageal disease should not use this treatment. Do not use Fosamax® if you are pregnant or nursing.
What about other medications?
When you are taking Fosamax®, it is very important that your doctors know if you are taking any other medicine. This includes prescription and non-prescription medicines as well as vitamins and herbal supplements.
Fosamax® treatment should be taken on its own without any other medications, and you must wait at least 30 minutes before taking other drugs. It is best to have your doctor’s advice before adding another medication to your daily routine.
GENERIC NAME: ALENDRONATE 70 MG WEEKLY SOLUTION – ORAL (a-LEN-droe-nate)
BRAND NAME(S): Fosamax
Medication Uses | How To Use | Side Effects | Precautions | Drug Interactions | Overdose | Notes | Missed Dose | Storage
USES: Alendronate is used to prevent and treat certain types of bone loss (osteoporosis) in adults. Osteoporosis causes bones to become thinner and break more easily. Your chance of developing osteoporosis increases as you age, after menopause, or if you are taking corticosteroid medications (such as prednisone) for a long time.This medication works by slowing bone loss. This effect helps maintain strong bones and reduce the risk of broken bones (fractures). Alendronate belongs to a class of drugs called bisphosphonates.
HOW TO USE: Read the Medication Guide provided by your pharmacist before you start taking alendronate and each time you get a refill. Follow the instructions very closely to make sure your body absorbs as much drug as possible and to reduce the risk of injury to your esophagus. If you have any questions, ask your doctor or pharmacist.This medication is taken once per week. Choose the day of the week that best fits your schedule and take it on that day each week.Take this medication by mouth, after getting up for the day and before taking your first food, beverage, or other medication. Drink at least 2 ounces (60 milliliters) of plain water after taking liquid alendronate. Then stay fully upright (sitting, standing, or walking) for at least 30 minutes and do not lie down until after your first food of the day. Alendronate works only if taken on an empty stomach. Wait at least 30 minutes (preferably 1 to 2 hours) after taking the medication before you eat or drink anything other than plain water.Do not take this medication at bedtime or before rising for the day. It may not be absorbed and you may have side effects.Calcium or iron supplements, vitamins, antacids, coffee, tea, soda, mineral water, calcium-enriched juices, and food can decrease the absorption of alendronate. Do not take these for at least 30 minutes (preferably 1 to 2 hours) after taking alendronate.Take this medication regularly to get the most benefit from it. Remember to take it on the same day each week. It may help to mark your calendar with a reminder. Talk to your doctor about the risks and benefits of long-term use of this medication.
SIDE EFFECTS: Stomach pain, constipation, diarrhea, gas, or nausea may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if you have any serious side effects, including: jaw pain, swelling of joints/hands/ankles/feet, increased or severe bone/joint/muscle pain, new or unusual hip/thigh/groin pain, black/tarry stools, vomit that looks like coffee grounds.This medication may infrequently cause serious irritation and ulcers of the esophagus. If you notice any of the following unlikely but very serious side effects, stop taking alendronate and talk to your doctor or pharmacist right away: new or worsening heartburn, chest pain, pain or difficulty when swallowing.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.In Canada – Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Fosamax Side Effects
12. Abdelmalek MF, Douglas DD “Alendronate-induced ulcerative esophagitis.” Am J Gastroenterol 91 (1996): 1282-3
13. Nightingale SL “Important information regarding alendronate adverse reactions.” JAMA 275 (1996): 1534
14. Levine J, Nelson D “Esophageal stricture associated with alendronate therapy.” Am J Med 102 (1997): 489-91
15. Miller PD, Woodson G, Licata AA, Ettinger MP, Mako B, Smith ME, Wang LX, Yates J, Melton ME, Palmisano JJ “Rechallenge of patients who had discontinued alendronate therapy because of upper gastrointestinal symptoms.” Clin Ther 22 (2000): 1433-42
17. Beauchesne MF, Miller PF “Etidronate and alendronate in the treatment of postmenopausal osteoporosis.” Ann Pharmacother 33 (1999): 587-99
19. McClung M, Clemmesen B, Daifortis A, et al. “Alendronate prevents postmenopausal bone loss in women without osteoporosis: a double-blind, randomized, controlled trial.” Ann Intern Med 128 (1998): 253-61
20. Rimmer DE, Rawls DE “Improper alendronate administration and a case of pill esophagitis.” Am J Gastroenterol 91 (1996): 2648-9
21. Graham DY, Malaty HM “Alendronate and naproxen are synergistic for development of gastric ulcers.” Arch Intern Med 161 (2001): 107-10
22. Yue QY, Mortimer O “Alendronate – Risk for esophageal stricture.” J Am Geriat Soc 46 (1998): 1581-2
24. Maconi G, Porro GB “Multiple ulcerative esophagitis caused by alendronate.” Am J Gastroenterol 90 (1995): 1889-90
25. Famularo G, De Simone C “Fatal esophageal perforation with alendronate.” Am J Gastroenterol 96 (2001): 3212-3
26. Liberman UA, Hirsch LJ “Esophagitis and alendronate.” N Engl J Med 335 (1996): 1069-70
27. Solomon DH, Patrick A, Brookhart MA “More on reports of esophageal cancer with oral bisphosphonate use.” N Engl J Med 360 (2009): 1789-90; author reply 1791-2
28. Wallace JL “Upper gastrointestinal ulceration with alendronate.” Digest Dis Sci 44 (1999): 311-2
29. Cummings SR, Black DM, Thompson DE, et al. “Effect of alendronate on risk of fracture in women with low bone density but without vertebral fractures: results from the fracture intervention trial.” JAMA 280 (1998): 2077-82
30. Devogelaer JP “Oral alendronate induces progressive increases in bone mass of the spine, hip, and total body over 3 years in postmenopausal women with osteoporosis (vol 18, pg 141, 1996).” Bone 19 (1996): 78
31. Bone HG, Greenspan SL, McKeever C, Bell N, Davidson M, Downs RW, Emkey R, Meunier PJ, Miller SS, Mulloy AL, Recker RR, We “Alendronate and estrogen effects in postmenopausal women with low bone mineral density.” J Clin Endocrinol Metab 85 (2000): 720-6
32. Peter CP “Upper gastrointestinal ulceration with alendronate – Response.” Digest Dis Sci 44 (1999): 312-3
33. Watts NB, Becker P “Alendronate increases spine and hip bone mineral density in women with postmenopausal osteoporosis who failed to respond to intermittent cyclical etidronate.” Bone 24 (1999): 65-8
34. Lanza F, Sahba B, Schwartz H, et al. “The upper GI safety and tolerability of oral alendronate at a dose of 70 milligrams once weekly: a placebo-controlled endoscopy study.” Am J Gastroenterol 97 (2002): 58-64
35. Lourwood DL “The pharmacology and therapeutic utility of bisphosphonates.” Pharmacotherapy 18 (1998): 779-89
37. Nussbaum SR, Warrell RP Jr, Rude R, Glusman J, Bilezikian JP, Stewart AF, Stepanavage M, Sacco JF, Averbuch SD, Gertz BJ “Dose-response study of alendronate sodium for the treatment of cancer- associated hypercalcemia.” J Clin Oncol 11 (1993): 1618-23
38. Mbekeani JN, Slamovits TL, Schwartz BH, Sauer HL “Ocular inflammation associated with alendronate therapy.” Arch Ophthalmol 117 (1999): 837-8
39. Isik A, Uras I, Uyar ME, Karakurt F, Kaftan O “Alendronate-induced asthma.” Ann Pharmacother 43 (2009): 547-8
Fosamax® and Osteonecrosis of the Jaw – Some New and Frequently Asked Questions
The alendronate (Fosamax®) drugs, known as the oral bisphosphonates, continue to be the cornerstones of treatment for prevention of osteoporosis. Unfortunately, they are associated with osteonecrosis of the jaw bone (ONJ), particularly if dental surgery is performed in long-term Fosamax users. Many questions have risen relative to the incidence, risk factors, mechanism of ONJ, symptoms of ONJ, and whether discontinuation of the drugs prior to dental surgery reduces risks of ONJ. All these questions and more are answered below.
1. According to the experts, what is the incidence of osteonecrosis of the jaw in Fosamax users?
Presently, the current estimates of the frequency of occurrence of ONJ in oral bisphosphonate users are the following. The American Dental Association has stated (and described in a previous newsletter) that the incidence is estimated to be 0.7 cases in 100,000 person years of exposure to oral bisphosphonates. The Medical Consultants of Consumer Reports On-Health Bulletin reported an incidence of 1 case for every 20,000 users of oral bisphosphonates (0.005%). A recent report from Australia estimated that the frequency of ONJ in osteoporotic patients, mainly on weekly oral alendronate (Fosamax), ranged from a minimum of 1 in 8,470 to a maximum of 1 in 2,260 (0.01% to 0.04%) patients. If extractions were performed, the frequency increased from 0.09% to 0.34%.
2. What numbers can I use to tell the dental patient their risk of developing ONJ with Fosamax?
The ADA suggests that the patient be informed that there is a very low risk of developing ONJ. The true risk posed by oral bisphosphonates remains uncertain, but researchers agree that it appears to be very small. All the data seem to point to a risk of approximately 0.1% of total users and that the risk increases with dental extractions to approximately 0.5%. Also, be aware that the risks of developing ONJ can be minimized but never totally eliminated. Good oral hygiene along with regular dental care is the best way to lower the risk of developing ONJ.
3. Is the risk of acquiring osteonecrosis of the jaw bone diminished with the use of other oral bisphosphonates, compared to Fosamax?
In addition to alendronate (Fosamax), cases of osteonecrosis of the jaw (ONJ), albeit rare, have been reported in patients taking either risedronate (Actonel®) or ibandronate (Boniva®). Among the class of oral bisphosphonates, more cases have been associated with Fosamax than with Actonel or Boniva. Also, there is no evidence to suggest that the risk of ONJ is less when taking monthly doses of Boniva. Zoledronic acid under the brand name of Reclast® has recently been approved as a once-annual, 15-minute intravenous infusion of a dose of 5 mg to prevent osteoporosis. This dosing was associated with a significant improvement in bone mineral density and bone metabolism markers. It is unknown whether this dosing schedule places the patient at risk for ONJ; however, data does show a higher risk of serious atrial fibrillation in patients receiving Reclast® compared to patients receiving placebo (Black DM, et al, NEJM, 356:1809-22).
4. Will Fosamax or the other oral bisphosphonates continue to be the standard treatment for osteoporosis?
Yes. The oral bisphosphonates continue to be the most effective class of drugs in reducing the risk of osteoporotic fractures and are the first-line therapy in the treatment of osteoporosis. Fosamax has been shown to prevent bone loss at the spine and hip in postmenopausal women, and to reduce fractures by approximately 50%. Risedronate (Actonel) produced a 30% reduction in hip fractures. Fosamax continues to be in the top 50 most widely-prescribed drugs in this country. By 2006, over 190 million prescriptions were dispensed worldwide.
5. Do we know how the jaw bone becomes necrotic from Fosamax?
This question has not been answered and information is only speculative at this time. Osteoporosis can occur due to age-related changes in the number of osteoclasts and bone resorption sites. This overwhelms the production of new bone by osteoblasts and a decrease in bone mass occurs. By inhibiting osteoclastic activity, the oral bisphosphonates seemingly arrest the osteoporotic syndrome. In the process, however, the maxilla and mandible, upon continued exposure to the bisphosphonates, are unable to repair themselves from injury from mechanical forces or invasive surgery such as tooth extraction. This, coupled with a reduction in bone blood supply by the bisphosphonates (antiangiogenic effect), leads to jaw bone necrosis.
6. What are the factors that increase the risk of jaw bone necrosis in Fosamax users?
Patients wih a history of periodontal disease and dental abscesses are at increased risk. Also, dento-alveolar trauma will increase the risk. The use of chronic steroids, such as prednisone, has been identified as a risk factor. Other factors are the duration of exposure and age, with longer treatment regimens and >65 years of age associated with a greater risk of developing the disease. Patients identified with jaw bone necrosis typically were exposed to oral bisphosphonates for 3 years or longer.
7. What are the symptoms that a Fosamax patient would experience which could indicate necrotic jaw bone?
Tooth mobility, mucosal swelling, and/or ulceration. Clinical symptoms would include a nonhealing extraction site, exposed bone surrounded by inflamed soft tissue, and purulent discharge at site of exposed bone. Exposed bone is usually more prevalent in areas such as tori and the mylohyoid ridge.
8. What kind of dental procedures can be performed in Fosamax users with no increase in risk for ONJ?
According to the American Dental Association, all routine procedures can be carried out. Routine dental treatment should not be modified on the basis of oral bisphosphonates on board the patient. However, presence of risk factors such as steroid use, >65 years of age, or prolonged exposure to the oral bisphosphonates may require consultation with an expert in metabolic bone disease prior to routine dental treatment.
9. Is dento-alveolar surgery contraindicated in Fosamax users?
No. According to Ruggiero and Drew (J Dental Research, 2007; 86(11):1013), in asymptomatic patients receiving oral bisphosphonate therapy, dento-alveolar surgery is not contraindicated.
10. Is a so-called “drug holiday” an effective way to reduce the risks of ONJ in Fosamax users prior to dental-alveolar surgery?
A “drug holiday” is a discontinuance of bisphosphonate for a length of time thought to achieve a reduction of risk of ONJ. It is suggested that one consider interrupting bisphosphonate treatment for 3-4 weeks prior to surgery and restarting after bone healing. Based on AAOMS (American Society of Oral and Maxillofacial Surgeons) guidelines, for patients who have taken an oral bisphosphonate for more than 3 years, discontinuation of the oral bisphosphonate for 3 months prior to oral surgery may reduce the risk. The bisphosphonate can be started again once osseous healing has occurred.
For individuals who have taken a bisphosphonate for less than 3 years and have no other risk factors for ONJ, no alteration or delay in the planned surgery is necessary (Ruggiero and Drew).
11. In patients about to begin oral bisphosphonate therapy, should the bisphosphonate be delayed until dental health is optimized?
No. It does not appear necessary for patients to initiate prophylactic dental treatment prior to initiating oral bisphosphonate therapy for osteoporosis. It would be prudent, however, to encourage these patients to maintain optimal dental health .
12. Is diagnostic imaging useful in assessing those bisphosphonate individuals at risk for ONJ?
Imaging modalities have proved helpful in determining the extent of existing necrotic process, but have not been able to demonstrate any efficacy in assessing patients at risk for ONJ. According to the experts, panoramic and periapical radiographs probably will not reveal significant changes in early stages of osteonecrosis and they are poor screening tools for prediction. Computerized tomography (CT) scan also has not proved helpful with early identification of osteonecrosis in asymptomatic patients.
alendronate (Binosto, Fosamax)
What should I discuss with my healthcare provider before taking alendronate (Binosto, Fosamax)?
You should not take alendronate if you are allergic to it, or if you have:
- low levels of calcium in your blood (hypocalcemia); or
- problems with the muscles in your esophagus (the tube that connects your mouth and stomach).
Do not take alendronate if you cannot sit upright or stand for at least 30 minutes. Alendronate can cause serious problems in the stomach or esophagus. You must stay upright for at least 30 minutes after taking this medicine.
To make sure alendronate is safe for you, tell your doctor if you have ever had:
- trouble swallowing;
- problems with your stomach or digestion;
- a dental problem (you may need a dental exam before you begin taking alendronate);
- kidney disease; or
- any condition that makes it hard for your body to absorb nutrients from food (malabsorption).
The effervescent tablet contains a lot of sodium. Tell your doctor if you are on a low-salt diet before using this form of alendronate.
In rare cases, this medicine may cause bone loss (osteonecrosis) in the jaw. Symptoms include jaw pain or numbness, red or swollen gums, loose teeth, or slow healing after dental work. The longer you use alendronate, the more likely you are to develop this condition.
Osteonecrosis of the jaw may be more likely if you have cancer or received chemotherapy, radiation, or steroids. Other risk factors include blood clotting disorders, anemia (low red blood cells), and a pre existing dental problem.
Talk with your doctor about the risks and benefits of using this medication.
It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.
It is not known whether alendronate passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.
How should I take alendronate (Binosto, Fosamax)?
Alendronate is taken either once daily or once per week. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.
Take alendronate first thing in the morning, at least 30 minutes before you eat or drink anything or take any other medicine. If you take alendronate only once per week, take it on the same day each week and always first thing in the morning.
Take with a full glass (6 to 8 ounces) of plain water. Do not use coffee, tea, soda, juice, or mineral water. Do not eat or drink anything other than plain water.
Measure liquid medicine with the dosing syringe provided, or with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.
Do not crush, chew, or suck on an alendronate regular tablet. Swallow it whole.
Dissolve the effervescent tablet in at least 4 ounces of water (at room temperature, not hot or cold). Let the tablet dissolve for 5 minutes. Stir this mixture for 10 seconds and drink all of it right away. Add a little more water to the glass, swirl gently and drink right away.
For at least 30 minutes after taking alendronate:
- Do not lie down or recline.
- Do not take any other medicine including vitamins, calcium, or antacids.
Pay special attention to your dental hygiene while taking alendronate. Brush and floss your teeth regularly. If you need to have any dental work (especially surgery), tell the dentist ahead of time that you are using alendronate.
Alendronate is only part of a complete program of treatment that may also include diet changes, exercise, bone mineral density testing, and taking calcium and vitamin supplements. Follow your doctor’s instructions very closely.
Store at room temperature away from moisture and heat. Keep unused effervescent tablets in the foil blister pack.
Your doctor will determine how long to treat you with this medicine. Alendronate is often given for only 3 to 5 years.
Osteoporosis Super-Foods for Strong Bones With Pictures See Slideshow
How does this medication work? What will it do for me?
Alendronate belongs to a family of medications known as bisphosphonates. It is used to treat and prevent osteoporosis for postmenopausal women. It is also used to treat osteoporosis for men.
Alendronate may also be used to treat and prevent steroid-induced osteoporosis for men and women (osteoporosis caused by taking corticosteroids such as prednisone for long periods of time). It may also be used to treat Paget’s disease of the bone for both men and women.
Alendronate increases the thickness of bone (bone mineral density) by slowing down the cells that usually break down bone (osteoclasts). This allows the cells that build bone (osteoblasts) to work more efficiently. By making bones stronger, alendronate can help to reduce the incidence of osteoporosis-related fractures.
This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.
Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.
Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.
What form(s) does this medication come in?
Each white, oval, biconvex tablet engraved “ALE70” on one side contains alendronate sodium equivalent to 70 mg of alendronate. Nonmedicinal ingredients: magnesium stearate, mannitol, and microcrystalline cellulose.
How should I use this medication?
When used for postmenopausal women, the recommended dose of alendronate to treat osteoporosis is one 10 mg tablet daily or 70 mg once weekly. To prevent osteoporosis, the recommended dose is 5 mg once a day.
To treat osteoporosis for men, the recommended dose of alendronate is one 10 mg tablet daily or 70 mg once weekly.
To treat and prevent steroid-induced osteoporosis for men and women, the recommended dose is 5 mg daily, except for postmenopausal women not taking estrogen. For those women, the recommended dose is 10 mg once a day.
When used to treat Paget’s disease of the bone for men and women, the recommended dose is 40 mg once a day for 6 months.
The tablet should be taken upon rising for the day, at least 30 minutes before the first food, beverage, or medication of the day. To reduce the risk of irritating the throat or esophagus, take the tablet with a full glass (250 mL) of plain water only.
After swallowing, do not lie down until at least 30 minutes have passed and you have eaten your first food of the day. Swallow the tablets whole. Do not chew or suck on the tablets.
Many things can affect the dose of a medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.
It is important that this medication be taken exactly as prescribed by your doctor. If you miss a dose when taking this medication once a day, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.
If you miss a dose when taking this medication once weekly, take the missed dose the morning after you remember. Then return to your weekly dose on the original day of the week. Do not take 2 doses on the same day. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.
Store this medication at room temperature and keep it out of the reach of children.
Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.
Who should NOT take this medication?
Do not take alendronate if you:
- are allergic to alendronate or any ingredients of the medication
- cannot stand or sit upright for at least 30 minutes
- have an abnormality of the esophagus (passage leading from throat to stomach) that delays the emptying of the esophagus into the stomach
- have low blood calcium
- have severely reduced kidney function
What side effects are possible with this medication?
Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.
The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.
The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.
Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.
- abdominal pain
- changed sense of taste
- hair loss
- mild skin rash or redness
- pain in bones, muscles, or joints
- rash that is made worse by sunlight
- spinning sensation
Although most of these side effects listed below don’t happen very often, they could lead to serious problems if you do not seek medical attention.
Check with your doctor as soon as possible if any of the following side effects occur:
- persistent ear pain
- severe joint, bone, or muscle pain
- symptoms of low calcium levels such as muscle spasms, and prickling or tingling sensations around the mouth or in the hands or feet
- vision changes or eye pain
Stop taking the medication and seek immediate medical attention if any of the following occur:
- delayed healing and infection of mouth and jaw (usually after tooth extraction)
- new or unusual pain in the hip or thigh
- signs of a serious allergic reaction (e.g., swelling of face or throat, hives, or difficulty breathing)
- signs of a severe skin reaction (e.g., high fever; rash; sores; painful blisters on the skin, mouth, or eyes; or skin peeling off)
- signs of damage to the esophagus (e.g., pain in the esophagus or behind the breastbone, chest pain, difficulty swallowing, pain when swallowing, or new or worsening heartburn)
- symptoms of a stomach or intestinal ulcer (e.g., nausea, vomiting, abdominal pain, loss of weight or appetite, black or bloody stools, or vomiting blood)
Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.
Are there any other precautions or warnings for this medication?
Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.
Atypical femur fracture: There is evidence that long term use of this class of medication may contribute to a type of rare fracture of the long bone in the thigh (femur) without any form of trauma.
If you experience new or unusual pain in the groin, hip, or thigh area, contact your doctor as soon as possible.
Bone, joint, and muscle problems: Rarely, people taking this medication experience severe bone, joint, or muscle pain. This is usually reversed when the medication is stopped.
Calcium and vitamin D: Calcium and vitamin D are important contributors to bone growth and strength. It may be necessary to take calcium or vitamin D supplements to get the best effect from alendronate if you are not getting enough from your diet. Your doctor may test you for low calcium levels or vitamin D deficiency before you start taking alendronate.
Effects on the esophagus: Alendronate may irritate the lining of the esophagus (the passage from the throat to the stomach). Esophagitis, ulcers, and erosions have been reported by people who take alendronate. In some cases, these effects have been severe and have required hospitalization. Contact your doctor at once if you suddenly experience problems swallowing, find it painful to swallow, develop pain behind the sternum (breastbone), or have new or worsening heartburn.
To ease the passage of the medication to the stomach and thus reduce the potential for irritation of the esophagus, swallow alendronate with a full glass of plain water upon arising for the day. Do not lie down until 30 minutes have passed and you have eaten your first food of the day. Do not chew or suck on the tablet, as this may lead to ulcers in the mouth or throat. Do not take alendronate at bedtime or before getting up for the day.
Effects on the stomach and intestines: Rarely, people taking this medication have developed ulcers of the stomach or intestines. If you suffer from stomach problems, such as ulcers and severe indigestion, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Get immediate medical attention if you have symptoms of a stomach or intestinal ulcer, such as nausea, vomiting, abdominal pain, loss of weight or appetite, black or bloody stools, or vomiting blood.
Inflammation of the eye: Conditions of eye inflammation have been reported by people using alendronate. If you experience changes to your vision, red eyes, or eye pain, contact your doctor as soon as possible.
Jaw problems: Rarely, alendronate may cause severe jaw problems associated with delayed healing and infection, especially in people with cancer or after tooth extractions. If you experience any pain in the jaw, especially after having a tooth removed, contact your doctor immediately.
Kidney function: Alendronate is removed from the body by the kidneys. If you have reduced kidney function or kidney disease, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.
Breast-feeding: It is not known if alendronate passes into breast milk. If you are a breast-feeding mother and are taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.
Children and adolescents: The safety and effectiveness of using this medication have not been established for children under 18 years of age.
What other drugs could interact with this medication?
There may be an interaction between alendronate and any of the following:
- aminoglycoside antibiotics (e.g., amikacin, gentamicin, tobramycin)
- antacids (e.g., aluminum hydroxide, calcium carbonate, magnesium hydroxide)
- ASA and ASA-containing products (when alendronate is taken in doses greater than 10 mg daily) – note that this does not apply to the 70 mg weekly dose
- calcium supplements (wait at least 30 minutes after taking alendronate to take calcium supplements)
- H2 antagonists (e.g., famotidine, ranitidine)
- non-steroidal anti-inflammatory medications (NSAIDs; e.g., diclofenac, ibuprofen, naproxen)
- proton pump inhibitors (e.g., lansoprazole, omeprazole)
- systemic angiogenesis inhibitors (e.g., axitinib, bevacizumab, lenalidomide, pazopanib, regorafenib, vandetanib)
- supplements containing minerals such as aluminum, calcium, iron, magnesium and phosphate
- other medications given by mouth (wait at least 30 minutes after taking alendronate to take any other medication by mouth)
If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:
- stop taking one of the medications,
- change one of the medications to another,
- change how you are taking one or both of the medications, or
- leave everything as is.
An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.
Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications that you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.
All material copyright MediResource Inc. 1996 – 2020. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/Alendronate-70