What can I take instead of singulair?

40 Million Sufferers

More than 40 million Americans suffer from seasonal hay fever, known medically as allergic rhinitis.

In the head-to-head comparison, Sudafed 24 Hour and Singulair proved equally effective for treating the most common hay fever symptoms, such as sneezing, nasal congestion, runny nose, and nose and throat itchiness.

The University of Chicago study included 30 hay fever sufferers who took 10-milligram doses of montelukast (Singulair) each morning for two weeks and 28 who took the once-a-day, 240-milligram dosage of pseudoephedrine. The study was financed by Singulair manufacturer Merck & Co. Inc. Merck is a WebMD sponsor.

Time-released 240-milligram capsules of pseudoephedrine cost about 80 cents a day on line, compared with nearly $3 for 10 milligrams of Singulair.

“Our hypothesis was that montelukast would have additional benefits and pseudoephedrine would interfere with sleep, but when we compared them head-to-head we found that for the treatment of allergic rhinitis, these drugs were virtually identical,” says researcher Fuad M. Baroody, MD.

The over-the-counter pseudoephedrine actually proved to be slightly more effective for reducing nasal congestion than Singulair, the researchers wrote.

The study is published in the February issue of the Archives of Otolaryngology – Head and Neck Surgery.

Question

Asked by joyce

Is There A Comparable Drug To Singulair?

I was taking singular for allergies and can no longer afford it because of no insurance.

Answer

Joyce,

Another over the counter antihistamine is Claritin/Loratidine, which is not supposed to make you sleepy. However, Zyrtec does not commonly cause drowsiness either, so the fact that you are experiencing that side effect may mean you are more susceptible. Still, the Claritin is probably worth a try. You might also try an antihistamine nasal spray and/or a nasal saline rinse, like the Netti Pot.

Before using antihistamines, tell your doctor or pharmacist your medical history, especially of:

  • breathing problems (e.g., asthma, emphysema)
  • a certain eye problem (glaucoma)
  • heart problems
  • high blood pressure
  • liver disease
  • seizures
  • stomach problems (e.g., ulcers, blockage)
  • overactive thyroid (hyperthyroidism)
  • urination problems (e.g., trouble urinating due to enlarged prostate, urinary retention)

To your health,

Kathi

Here is more information on common over-the-counter antihistamines:

3 Reasons to Choose OTC Antihistamines Over OTC Decongestants to Treat Your Allergy Symptoms

Antihistamine Oral Uses and How to Use

Nasal Decongestants and Antihistamines Oral Precautions and Side Effects

FDA Panel Rejects OTC Use of Montelukast (Singulair Allergy)

The Nonprescription Drugs Advisory Committee of the US Food and Drug Administration (FDA) has voted against recommending that montelukast (Singulair Allergy, Merck) be approved as an over-the-counter (OTC) drug for the treatment of allergic rhinitis (AR).

Montelukast has been a prescription medicine for the treatment of asthma for children and adults since 1998, for seasonal AR since 2002, for perennial AR since 2005, and for exercise-induced bronchoconstriction since 2007.

Merck has asked for FDA approval on a partial addition to OTC for adults 18 years old and older only, and only for the treatment of allergy symptoms, with specific wording that it not be used OTC for asthma treatment and specific warning that it not be used for children younger than 18 years. The dosage requested for OTC is 10 mg/day, which is the current approved dosage for individuals 15 years old and older.

On a question before the committee regarding whether “the safety of OTC use for relief of allergy symptoms, considering off-label use, been adequately demonstrated,” 11 panel members voted no and 4 voted yes.

On the other question before the committee, regarding whether “the risk/benefit profile of montelukast sodium supportive of OTC use in adults for the nasal indication ‘temporary relieves these symptoms due to hay fever and other respiratory allergies,’ ” the vote count came out the same, but with 2 panel members changing their votes on the second question.

Merck has asked the FDA to add ocular symptoms of allergies in the indication, along with currently approved language on daytime nasal symptom relief, to the OTC labeling, but FDA staff members took that option off the table for the advisory committee vote.

Montelukast has been approved for prescription use in more than 100 countries worldwide and has about 66 million patient-years of exposure with about 24 million dose units being prescribed, according to Merck officials. But no countries have approved it for OTC use.

Still Do Not Know

But it is what is still unknown that led to committee members’ decisions, particularly with regard to potential off-label use for asthma patients and for pediatric patients, as well as potential neuropsychiatric adverse effects, including suicide.

Although clinical trials assessed for approval of prescription of montelukast did not turn up neuropsychiatric adverse effects as a safety factor, adverse event reports in postmarketing databases have, primarily for depression, aggression, irritability, nightmares, and insomnia, FDA officials said at the committee hearing.

The FDA initiated a safety review of drugs that act through the leukotriene pathway, including montelukast, and potential association with neuropsychiatric events, including suicidality. The suicide of a 15-year-old boy taking montelukast in 2007 was 1 event prompting the review, according to FDA documents. The FDA review found 43 completed potentially related suicides between March 2008 and October 2013.

Merck amended its product labels to include a precaution against neuropsychiatric events, which the FDA approved in 2009 and has planned to continue the labeling for OTC use.

But committee members were not satisfied with labeling as a solution to uncertainties.

As to potential neuropsychiatric adverse effects, “We really just don’t know much about them,” said committee member Tobias Gerhard, PhD, RPh, assistant professor of pharmacy at Rutgers University, New Brunswick, New Jersey. He questioned whether the association would become a bigger problem if OTC use was approved.

He also questioned what effect OTC use for allergies might have on patients with asthma, many of whom have concomitant allergies and are already taking montelukast as a prescription.

Merck’s proposed labeling information advises patients who are taking asthma medications to continue their treatments. However, panel members questioned whether some patients, to save money, might drop their asthma medications because montelukast in prescription form is approved for asthma and allergies.

“If only 0.1% of patients stopped taking their medications, it has a potentially significant risk,” said Dr. Gerhard.

“Conflicting Testimonials”

Panel members were also struck by “conflicting testimonials” during the hearing as to montelukast’s benefits and risks, said committee member Kenneth Towbin, MD, chief of the Clinical Child and Adolescent Psychiatry Unit at the National Institutes of Health in Bethesda, Maryland. Among the witnesses at the public hearing portion of the hearing were 2 parents who described their children’s neuropsychiatric adverse reactions to montelukast.

“Conflicting testimonials are difficult to be used in making scientific decisions, especially with no scientific data to assist us in understanding neuropsychiatric events,” Dr. Towbin said.

Committee members in favor of adding the drug to OTC use and Merck officials expressed concern that the safety issues were overblown, considering that the drug has been used so much already and that the safety profile is considered positive overall.

Committee chair Ruth M. Parker, MD, professor of medicine at Emory University School of Medicine in Atlanta, Georgia, summed up the reasons for resistance to adding OTC use as the risk of being used off-label and the complexity of the labeling being too difficult for the average adult to understand.

The advisory committee members have disclosed no relevant financial interests.

No, and it looks like it won’t be. Here are the reasons a panel of experts just voted to tell the FDA not to allow Singulair to be sold without a prescription. Singulair, now available as the generic montelukast, is a popular and effective allergy medication also used in asthmatics who have allergies. It is a leukotriene receptor antagonist which works differently than the other allergy meds (the non-sedating antihistamines like Claritin, Allegra or Zyrtec). So why the rejection?

1. People will buy Singulair thinking it will help them with an acute asthma attack. The concern of members on this panel was that Singulair would be used by patients as a rescue medication, similar to their inhalers (steroid inhalers or inhaled bronchodilators). It should not be used that way.

2. Remember that Singulair is NOT approved for use to reverse bronchospasm in acute asthma attacks. This means if you are having shortness of breath and wheezing from your asthma singulair will not help you in the short term.

3. The people on this panel are worried you will choose and buy Singulair over your inhaled corticosteroid (Flovent or Pulmicort as examples) for asthma prevention. That could lead to a significant delay in appropriate treatment for exacerbations. That’s bad.

4. What we DO like Singulair for is use in patients with both asthma and allergic rhinitis (runny nose from allergies). A daily dose may help you with both your allergies and to help prevent asthma exacerbations.

5. Singulair is also good for prevention of exercise-induced bronchoconstriction (wheezing and shortness of breath worsened with exercise) at a dose of 10 mg at least 2 hours prior to exercise.

No over the counter status for Singulair any time soon.

Dr O.

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  • Camber Pharmaceuticals is recalling one lot of montelukast sodium tablets because the bottles are labeled “montelukast sodium tablets, 10-mg, 30-count” but actually contain 90 tablets of losartan potassium, 50 mg.

    “This tablet mix-up may pose a safety risk as taking losartan tablets when not prescribed has the potential to cause renal dysfunction, elevated potassium levels and low blood pressure,” the US Food and Drug Administration (FDA) warns in a news release.

    “This risk is especially high for pregnant women taking the allergy and asthma medication montelukast because losartan, which is indicated to treat high blood pressure, could harm or kill the fetus,” the FDA says.

    The lot number for the recalled product is MON17384, the expiration date is 12/31/2019, and the national drug code is 31722-726-30.

    “We want to ensure that patients who take montelukast are aware of this recall due to the serious risks associated with taking losartan in its place,” said Donald Ashley, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research. “Patients who take prescription drugs expect and deserve to have the medication their doctor prescribed.”

    The FDA is asking patients to contact their healthcare provider or pharmacist to determine whether their montelukast medication has been recalled.

    To date, Camber has not received adverse event reports associated with this recall. The FDA encourages healthcare professionals and consumers to report adverse events to the FDA’s MedWatch Adverse Event Reporting Program.

    FDA Panel Nixes OTC Singulair

    Montelukast (Singulair) should not be allowed over-the-counter use for hay fever and other upper respiratory allergy symptoms, an FDA advisory panel recommended Friday.

    The advisors voted 11-to-4 against a risk-benefit ratio supportive of OTC use to treat nasal congestion, runny nose, itchy, watery eyes, sneezing, and itching of the nose in adults.

    The vote was likewise 11 no’s versus 4 yes’s that OTC use would be safe, considering the potential for off-label use if the FDA followed a positive recommendation from the advisory committee, which it usually does.

    The partial switch from prescription to OTC use (trade name Singulair Allergy) was proposed only for adults at the once-daily 10 mg dose, while the drug would remain under prescription for the currently approved indication for seasonal allergic rhinitis in children as young as 2 years and older and for perennial allergic rhinitis in those as young as 6 months.

    However, a substantial proportion of current prescription use is in children, which the panel expressed concern could mean unintended OTC use in that group.

    A study in adolescents ages 15 to 17 submitted by drugmaker Merck to support the application showed that too many teens thought it was right for them to use, despite labeling only for adults.

    The lower bound came in at 80% correct answers versus the target of over 90%, although the teens did meet targets for comprehension of warnings for neuropsychiatric events.

    That risk was also a concern discussed by the panel.

    Montelukast poses a significantly greater risk than existing over-the-counter allergy medications, Michael Carome, MD, director of Public Citizen’s Health Research Group, argued during the open public hearing portion of the discussion.

    “Among the side effects: agitation, aggressive behavior, anxiety, depression, hallucinations, insomnia, irritability and suicidal thoughts,” he warned. “If people could buy Singulair without a prescription, the potential for inappropriate and potentially dangerous use is high.”

    While montelukast is otherwise generally safe, “you can imagine that would be concerning for a physician to not be aware of if it was happening to their patient,” Tara F. Carr, MD, director of the adult allergy program at the University of Arizona College of Medicine in Tucson, agreed in an interview with MedPage Today.

    A label comprehension study in adults with allergic rhinitis showed that nearly all understood the warnings about changes in mood, behavior, or thoughts or changes in sleep that the FDA has warned about with this class, both questions meeting the 90% threshold for lower bound.

    Montelukast would have been the first in the leukotriene receptor antagonist class to make the switch from prescription to OTC.

    Other OTC treatments for allergic rhinitis include oral antihistamines, oral combinations of an antihistamine and decongestant, intranasal decongestants, intranasal cromolyn, and an intranasal corticosteroid.

    Having another class of drugs available would be an advantage for patients, George Philip, MD, an allergist and executive director of clinical research and product development at Merck.

    He cited studies showing that nearly 40% of allergy patients switch among medications, and about a quarter aren’t satisfied with their medication.

    “Over-the-counter therapies have been playing an increasingly important role,” he told MedPage Today in advance of representing the drug before the panel. “Based on the labeling of those products, not all currently available OTC products are right for all consumers.”

    Moreover, for patients, cost is a barrier to use, commented David Lang, MD, chair of allergy and clinical immunology at the Cleveland Clinic.

    “When medications go over the counter, frequently the cost goes down, it becomes more affordable, and more individuals have access to the drug,” he told MedPage Today.

    The bigger concern for the panel, though, was montelukast would have been the first OTC drug that’s also an approved asthma controller medication.

    Although proposed to remain under prescription for that indication, off-label use and the considerable overlap between the two conditions raised the complexity of the decision.

    Up to 40% of allergic rhinitis patients are also estimated to have asthma; while up to 90% of asthma patients have allergic rhinitis.

    “The concern is that the use of the drug by patients in an unrestricted fashion may extend beyond allergic rhinitis, specifically that patients may self-medicate and treat their asthma and delay seeking medical care and get into trouble with their asthma,” Lang explained.

    The self-selection and label comprehension study in adults with asthma showed that the majority of patients correctly selected themselves for use by allergic rhinitis status, but the target of a lower bound of at least 90% correct answers wasn’t met for understanding that the drug should not be used to treat asthma.

    Merck also asked that the OTC indication include “itchy, watery eyes,” which has not been part of the existing prescription labeling.

    The evidence to support an ocular indication came from post-hoc analysis of a secondary endpoint in three seasonal allergic rhinitis trials.

    Only one of the three trials showed a significant improvement in daytime eye symptom score (an average of tearing, itchy, and red and puffy eyes), and that improvement had an effect size of 0.14.

    “It is unclear whether the small change represents a clinically meaningful improvement,” the FDA staff review noted.

    Comment

    Singulair Alternatives for Kids

    Q1. What medications are available other than Singulair for my 6-year-old son? He has taken Zyrtec since he was 2 years old, along with Singulair, which he started at 3. I recently took him off of Singulair because he acts up tremendously while on the medication. But being on Zyrtec is not enough. He has already been on one round of antibiotics and is close to being on his second.

    You did not specify whether your son is being treated for nasal symptoms or asthma, and both Singulair and antihistamines (like Zyrtec) can be used for both conditions. So, I will answer in a general way: For either problem, you should consider corticosteroid sprays. These are some of the most effective and safe types of treatments for either nasal symptoms or asthma, and they often help when antihistamines and Singulair do not.

    Corticosteroid nasal sprays are not whole-body medicines, unlike the two you have been using, and do not affect children’s behavior — although if the child can breathe better, his energy and activity may increase. The main issue with these sprays is that administration can be a bit difficult with some children. If your son doesn’t like the nose spray, try the following trick: Wait until he falls asleep and is deeply down (20 minutes or so), and then spray his nose. Just administer one spray per side to minimize dripping of the medicine down the throat. I do this with my own daughter, and she never wakes up.

    In contrast, corticosteroid inhalers for asthma shouldn’t be administered to sleeping children because their cooperation is needed to breathe in the medicine properly. However, most 6-year-old children are able to cooperate.

    Q2. My son Andre has been suffering from asthma since he was 18 months old. He’s 28 now, and his doctor recently diagnosed him with ADD/ADHD. Is that common among asthmatics? How are the two linked?

    Behavioral and emotional problems — such as attention deficit disorder, hyperactivity, and depression — are somewhat more common in children (and presumably adults) with asthma, but the link is not entirely clear. Doctors don’t know whether there is a biological reason that they occur together, or whether the social pressures caused by having asthma lead to behavioral and emotional issues.

    Researchers have also found higher rates of behavioral problems in children with other types of long-term illnesses besides asthma, so some of the effects are probably caused by the stress of dealing with a chronic condition. Behavioral and emotional problems, however, are not caused by the use of asthma medications: Several studies have indicated that inhaled corticosteroids do not influence behavior or make children hyperactive. I wish I could tell you more, but this is as much as research has currently revealed.

    Q3. I have a seven-year-old son with moderately severe asthma, and also a five-year-old son that lately has been having coughing spells that seem to start in the evening and continue off and on during the night, sometimes so bad, his gag reflex will almost kick in. You can hear some “junk” as he tries to cough, but nothing comes up. Could he possibly be showing early symptoms of having asthma? His brother was diagnosed at 15 months.

    — Aubrey, Texas

    Like most mothers, your instincts are right. Your five-year-old’s symptoms sound very much like asthma. The three most common symptoms are cough, chest tightness and wheezing, but not everyone has all three symptoms, and many people, especially children, just cough. The cough commonly gets worse in the evening when the person is trying to get to sleep and can also wake the individual up between 4 and 6 a.m., although coughing may be present any time of the day or night.

    Other cough patterns that are characteristic of asthma include cough with exercise, cough with cold air exposure, and prolonged cough (weeks to months) after colds. The cough of asthma is usually dry, although some people with asthma bring up a small amount of clear or white or yellowish sputum. It sounds like your son’s symptoms fit this description. I would talk to your pediatrician about starting an asthma medication and if the cough clears, you can be reasonably sure that asthma was the right diagnosis.

    What else could cause a chronic cough? Another common type of cough in children and adults is caused by post-nasal drip, or draining of the sinuses down the back of the throat. This type of cough sounds a bit more wet, but it is not deep in the chest like bronchitis. It sounds like the person is constantly clearing their throat. The best treatment for post-nasal drip is a prescription spray containing low doses of anti-inflammatory steroids, which are used for nasal allergies and other forms of nasal congestion.

    There are a few other causes of coughing in children, but your son’s symptoms fit so well with asthma that I would start by looking into that. I would see to it promptly too, so that he can get a good night’s sleep again. If he does turn out to have asthma or post nasal drip, ask your doctor about whether he should be evaluated for allergies, as there may be something about his environment that you could change to help him.

    Q4. I have a son who has been diagnosed with asthma but is hooked on smoking. Is there a book or booklet that will let him read about how much he’s hurting himself and his lungs by doing this?

    Smoking is an awful habit for anyone but especially bad for people with lung disease. The good news is that at least some of the damage is reversible by quitting. A study published in 2006 found that asthmatic smokers improved their performance on lung function tests by 15 percent when they quit.

    The various national groups – the American Academy of Allergy, Asthma and Immunology, the American College of Allergy, Asthma and Immunology and the American Lung Association – all have wonderful teaching materials to help your son stop smoking.

    Q5. Two years ago I was diagnosed with asthma, and scarring on both lungs. I have not smoked in almost 20 years, and I was not a heavy smoker (about six cigarettes a day). In 1996 I began to encounter upper respiratory infections almost on a monthly basis. The infections seemed to be triggered by exposure to secondhand smoke. And presently, nothing sets off my asthma like secondhand smoke. The pulmonologist hasn’t been able to give me a definitive reason for my developing asthma in my late forties (as there is no prior history). It is possible it’s the secondhand smoke?

    Even though many people develop asthma at a young age, there are those who are diagnosed with asthma at age 40, 50, 60 or even older. No one knows why people develop asthma, and it results from different causes in each individual patient.

    It sounds as though you have significant damage to your lungs from both smoking and secondhand smoke exposure. It would probably suit you to obtain a second opinion to make sure that this is indeed asthma and not chronic obstructive pulmonary disease (COPD).

    Learn more in the Everyday Health Asthma Center.

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