- Lose weight and keep it off with diet, exercise and Qsymia1,2
- FDA approves weight loss drug Qsymia, but we say skip it
- Qsymia Review: Does It Work and Is It Safe?
- What is Qsymia and Does it Work?
- FDA Approved Qsymia
- Is Qsymia Safe?
- Getting Started with Qsymia
- What Does Qsymia Cost?
- Are There Any Alternatives?
- What Are Users Reporting?
- The Bottom Line
- SIDE EFFECTS
- Editor’s Note
- In this article, you will read…
- How Does Qsymia Work?
- Is Qsymia the best weight loss pill? Are there better options available?
- Related posts:
Lose weight and keep it off with diet, exercise and Qsymia1,2
§HOME DELIVERY PHARMACY
Additional shipping and handling costs will apply. $98 pricing includes 6-week New Patient Packs, 6-week Titration Packs and all 30-day prescriptions. Please see QsymiaAdvantage.com for full program details.
Qsymia should be used together with a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of:
- 30 kg/m2 or greater (obese) or
- 27 kg/m2 or greater (overweight) in the presence of at least one weight-related medical condition such as high blood pressure, type 2 diabetes, or high cholesterol
LIMITATIONS OF USE:
- It is not known if Qsymia changes your risk of heart problems or stroke or of death due to heart problems or stroke
- It is not known if Qsymia is safe and effective when taken with other prescription, over-the-counter, or herbal weight loss products
- It is not known if Qsymia is safe and effective in children under 18 years old
Important Safety Information
Do not take Qsymia if you are pregnant, planning to become pregnant, or become pregnant during Qsymia treatment; have glaucoma; have thyroid problems (hyperthyroidism); are taking certain medicines called monoamine oxidase inhibitors (MAOIs) or have taken MAOIs in the past 14 days; are allergic to topiramate, sympathomimetic amines such as phentermine, or any of the ingredients in Qsymia. See the end of the Medication Guide for a complete list of ingredients in Qsymia.
Qsymia can cause serious side effects, including:
Birth defects (cleft lip/cleft palate). If you take Qsymia during pregnancy, your baby has a higher risk for birth defects called cleft lip and cleft palate. These defects can begin early in pregnancy, even before you know you are pregnant. Women who are pregnant must not take Qsymia. Women who can become pregnant should have a negative pregnancy test before taking Qsymia and every month while taking Qsymia and use effective birth control (contraception) consistently while taking Qsymia. Talk to your healthcare provider about how to prevent pregnancy. If you become pregnant while taking Qsymia, stop taking Qsymia immediately, and tell your healthcare provider right away. Healthcare providers and patients should report all cases of pregnancy to FDA MedWatch at 1-800-FDA-1088, and the Qsymia Pregnancy Surveillance Program at 1-888-998-4887.
Increases in heart rate. Qsymia can increase your heart rate at rest. Your healthcare provider should check your heart rate while you take Qsymia. Tell your healthcare provider if you experience, while at rest, a racing or pounding feeling in your chest lasting several minutes when taking Qsymia.
Suicidal thoughts or actions. Topiramate, an ingredient in Qsymia, may cause you to have suicidal thoughts or actions. Call your healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you: thoughts about suicide or dying; attempts to commit suicide; new or worse depression; new or worse anxiety; feeling agitated or restless; panic attacks; trouble sleeping (insomnia); new or worse irritability; acting aggressive, being angry, or violent; acting on dangerous impulses; an extreme increase in activity or talking (mania); other unusual changes in behavior or mood.
Serious eye problems, which include any sudden decrease in vision, with or without eye pain and redness or a blockage of fluid in the eye causing increased pressure in the eye (secondary angle closure glaucoma). These problems can lead to permanent vision loss if not treated. Tell your healthcare provider right away if you have any new eye symptoms.
Possible side effects of Qsymia include:
Mood changes and trouble sleeping. Qsymia may cause depression or mood problems, and trouble sleeping. Tell your healthcare provider if symptoms occur.
Concentration, memory, and speech difficulties. Qsymia may affect how you think and cause confusion, problems with concentration, attention, memory or speech. Tell your healthcare provider if symptoms occur.
Increases of acid in bloodstream (metabolic acidosis). If left untreated, metabolic acidosis can cause brittle or soft bones (osteoporosis, osteomalacia, osteopenia), kidney stones, can slow the rate of growth in children, and may possibly harm your baby if you are pregnant. Metabolic acidosis can happen with or without symptoms. Sometimes people with metabolic acidosis will: feel tired, not feel hungry (loss of appetite), feel changes in heartbeat, or have trouble thinking clearly. Your healthcare provider should do a blood test to measure the level of acid in your blood before and during your treatment with Qsymia.
Low blood sugar (hypoglycemia) in people with type 2 diabetes mellitus who also take medicines used to treat type 2 diabetes mellitus. Weight loss can cause low blood sugar in people with type 2 diabetes mellitus who also take medicines used to treat type 2 diabetes mellitus (such as insulin or sulfonylureas). You should check your blood sugar before you start taking Qsymia and while you take Qsymia.
High blood pressure medicines. If you are taking medicines for your blood pressure, your doctor may need to adjust these medicines while taking Qsymia.
Central Nervous System (CNS) side effects. The use of prescription sleep aids, anxiety medicines, or drinking alcohol with Qsymia may cause an increase in CNS symptoms such as dizziness and light-headedness. Do not drink alcohol with Qsymia.
Possible seizures if you stop taking Qsymia too fast. Seizures may happen in people who may or may not have had seizures in the past if you stop Qsymia too fast. Your healthcare provider will tell you how to stop taking Qsymia slowly.
Kidney stones. Drink plenty of fluids when taking Qsymia to help decrease your chances of getting kidney stones. If you get severe side or back pain, and/or blood in your urine, call your healthcare provider.
Decreased sweating and increased body temperature (fever). People should be watched for signs of decreased sweating and fever, especially in hot temperatures. Some people may need to be hospitalized for this condition.
Common side effects of Qsymia include:
Numbness or tingling in the hands, arms, feet, or face (paraesthesia); dizziness; changes in the way foods taste or loss of taste (dysgeusia); trouble sleeping (insomnia); constipation; and dry mouth.
Tell your healthcare provider if you have any side effect that bothers you or does not go away. These are not all of the possible side effects of Qsymia. For more information, ask your healthcare provider or pharmacist.
The Q and Me® Patient Support Program is based on the LEARN® Program provided under copyright license (September 15, 2010). All rights reserved.
*BMI (body mass index) measures the amount of fat in the body based on height and weight. BMI is measured in kg/m2.
†Or a BMI of 27 or more with one weight-related medical condition.
1. Qsymia Full Prescribing Information. Campbell, CA: VIVUS, Inc; 2017. 2. Data on File. VIVUS, Inc.
FDA approves weight loss drug Qsymia, but we say skip it
The Food and Drug Administration Tuesday approved Qsymia, a combination of the stimulant phentermine and the anti-seizure drug topiramate extended-release, to help obese and overweight people lose weight. But our medical advisers say the pill should be avoided because it can cause several serious side effects.
According to the evidence submitted to the FDA, Qsymia appears to help people drop a few pounds. In studies, obese and overweight people who took Qsymia for one year lost 3.5 to 9.4 kg more than those who took a placebo. But that small benefit is probably not worth the risks of birth defects, heart attacks, and strokes. In fact, two years ago the FDA rejected the drug, then called Qnexa, due to these concerns, and it is not clear why the FDA reversed course this time, since those side effects are still an issue.
The drug also carries a warning that it can increase heart rate and should not be used by people who have heart disease or have suffered a stroke. Due to the heart concern, Vivus, the manufacturer of Qsymia, is required to conduct a study to determine whether the drug poses a risk of major cardiovascular problems, including heart attack and stroke. Also too, pregnant women should not take Qsymia because it increases the risk of their children being born with a cleft lip or palate.
Qsymia will only be available through specially certified pharmacies under a Risk Evaluation and Mitigation Strategy, or REMS, which is intended to inform doctors and patients about the possibility of birth defects.
“The very idea that a post marketing risk evaluation strategy was a condition required by the FDA for approval of this combination drug product seems like putting the cart ahead of the horse,” says Marvin Lipman, M.D., chief medical adviser for Consumer Reports. “Such a study may very well result in preventable mortality and morbidity, a high price to pay in exchange for a few pounds of flesh.”
Qsymia contains several additional warnings, including that it can increase the risk of glaucoma, kidney stones, mood problems such as anxiety and depression, and suicidal behavior or thinking about suicide (ideation).
“This drug should only be used in the confines of a research trial in which consumers have been fully informed of its risks and benefits and, someone is responsible for the complications that occur. All the rest of us should wait until we know a lot more about its safety,” says John Santa, M.D., director of the Consumer Reports Health Ratings Center.
Bottom Line: We recommend avoiding all weight-loss drugs and supplements. Their benefits are usually marginal. And even if they do help you to shed a few pounds, the side effects can be troublesome and even dangerous.
If you need to lose weight, increasing exercise and limiting portion size when it comes to food are better options.
How to control your weight
Weight-loss drugs: Alli and Xenical (Orlistat): Slim benefits and embarrassing side effects
Lose weight, stay active: Six small changes can help keep off pounds
FDA approves weight-management drug Qsymia
Panel recommends FDA approve weight loss drug Qnexa
Note: This blog has been updated to reflect two corrections from “3.5 to 9.3 pounds” to “3.5 to 9.4 kg.”
Qsymia Review: Does It Work and Is It Safe?
By Anthony Dugarte, M.D., C.S.C.S Updated on: Jan 3, 2020
Qsymia is a prescription medication that claims to offer weight loss by helping you control hunger and resist cravings.
It’s no secret that obesity is a growing problem in the US. Nearly 40% of adults are considered obese, with a Body Mass Index (BMI) greater than 30. This condition is more like to affect minorities and those with a lower socioeconomic status.
As obesity rates appear to be climbing, there is an arms race in the medical, fitness, and wellness sectors to develop the most effective means of battling this issue.
Qsymia claims to be an effective part of a comprehensive weight loss plan. But does it work?
This review examines the safety and efficacy of Qsymia.
What is Qsymia and Does it Work?
Qsymia is an FDA approved prescription medication that, when used in conjunction with diet and exercise, claims to offer sustainable weight loss. This is thought to be possible by offering a blend of phentermine and topiramate in capsule form.
Originally approved in the late 50s to treat overweight individuals in a short-term setting, phentermine is the most commonly prescribed ani-obesity drug in the US. This medication is thought to work by suppressing appetite and increasing the activity of your sympathetic nervous system.
In 2010, treatment with 30mg of phentermine significantly reduced body weight over 12-weeks in obese individuals when compared to placebo. Treatment for longer than 12-weeks is considered an off-label use, and may warrant further investigation.
In a 36wk trial, 30mg of phentermine was associated with weight loss about 3x more than the placebo group, though less than 60% of patients completed the trial (see safety below).
Topiramate is often used to manage epilepsy and headaches. Initially discovered when treating these conditions, the weight loss effect mechanism of action remains unclear.
What is clear, is that weight loss is achievable with topiramate. Dosing at 64, 96, 192, and 384 mg/day all resulted in significant weight loss when compared to placebo. This was later confirmed in another trial, as well as a review.
FDA Approved Qsymia
In review of various combinations of currently available medications offered to treat overweight and obese adults, combining phentermine and topiramate was associated with the highest odds of achieving at least 5%weight loss.
Five clinical trials were largely responsible for Qsymia’s FDA approval.
- EQUIP demonstrated significant weight loss at 1-year when Qsymia was used in conjunction with a calorie restricted diet.
- EQUATE offered similar results in approximately 6-months.
- CONQUER investigated the effects of Qsymia over a 56-week period in obese and overweight subjects. Again, subjects were treated in conjunction with following a calorie restricted diet and significant improvements were found for weight loss and waist circumference.
- SEQUEL was a 2-year extension study of the CONQUER subjects, once again demonstrating significant weight loss when compared to placebo.
- FORTRESS, sponsored by the manufacturer of Qsymia, found that the risk for oral cleft at birth was 1.5 per 1,000 for those exposed to topiramate in the first trimester.
Qsymia contains phentermine and topiramate; each medication has been proven to be effective for weight loss in its own right. When offered together, and in conjunction with a calorie restricted diet, they offer the greatest potential for weight loss.
Is Qsymia Safe?
Though there is plenty of scientific support supporting the effectiveness of both phentermine and topiramate in managing, these medications are not without risk.
In an early study examining daily treatment with 30mg of phentermine in obese patients, less than 60% were able to finish the 36-week trial – highlighting the need to identify potential harm in long-term studies, as well as the importance of physician-guided use of this drug. Common side effects in this study were dry mouth, constipation, and headache.
Dry mouth and insomnia were noted more recently, and more dangerous side effects may include elevations in blood pressure or heart rate
Abnormal skin sensations, sleepiness, as well as decreased memory, concentration, and attention were the most common side effects in a study examining topiramate treatment at 64, 96, 192, or 384mg/day for weight loss. Twenty-one percent of those treated with topiramate left the study due to adverse events – this was nearly double the amount in the placebo group.
Topiramate is also known to negatively affect the eyes, kidneys, and is associated with an increased risk for birth defects.
Qsymia – Combination Treatment with Phentermine and Topiramate
Most commonly, abnormal skin sensations, dry mouth, constipation, altered sense of taste, and insomnia are described. Serious adverse effects like birth defects were also found.
For these reasons, Qsymia is sure to highlight both the need to be managed under the care of a physician while using this medication, as well as the potential risk involved. Their detailed breakdown can be found here, and we will summarize below.
Do not take with:
- Monoamine oxidase inhibitor treatment
Risk for Abuse and Drug Dependency
The phentermine content makes Qsymia CIV federally controlled substance. This product has the potential for abuse or drug dependence.
Qsymia states that a pregnancy test must be taken before, and during use. Heart rate, signs of depression, symptoms of increased eye pressure, mental ability, and blood glucose must all be monitored closely.
The most common adverse reactions are abnormal skin sensations, dizziness, altered taste, insomnia, constipation, and dry mouth.
Medications That Have the Potential to Interact Negatively with Qsymia
- Birth control pills
- blood pressure medications
Limitations of Use:
Safety regarding an increased risk for cardiovascular events, use with other weight loss products, and for use in those under age 18 is not yet known.
Qsymia is an effective weight loss option for overweight and obese patients. Though the most common side effects are relatively mild, the considerable risk does exist for those currently or planning to become pregnant, those on blood pressure medication, and those with a history of drug abuse.
Getting Started with Qsymia
Your doctor must send your Qsymia prescription to their certified home delivery pharmacy partner, MedVantx.
Qsymia does not offer telemedicine, so a trip to your provider is necessary. This may be a good thing as this medication requires working closely with your physician to monitor dosing, progress, and safety.
Qsymia recommends use along with a reduced-calorie diet and increased physical activity in adults with a BMI greater than 27kg/m2. Height and weight should be recorded at your doctor visit. Additionally, be sure to go over a detailed medical history and provide a list of medications for their review.
Dosages per capsule (phentermine mg/topiramate mg extended-release) are listed below. As this varies throughout treatment, management in conjunction with your physician is vital.
- 3.75 mg/23 mg – this dose is recommended for the first 2-weeks of treatment.
- 7.5 mg/46 mg – this dose is started at week 3, and continued if you have lost 3% of your body weight. After 3-months, your doctor may want to increase the dose if you’ve lost less than 3%.
- 11.25 mg/69 mg – this dose is started at week 13 if the weight loss has been less than 3%.
- 15 mg/92 mg – this is the top dose of Qsymia, started after 4 weeks of treatment at 11.25mg/69mg.
After your visit, register online (it may take 1 business day for your prescription to load), provide your payment and shipping info, complete your order, and wait 5-7 days for your Qsymia to arrive.
Once your prescription is in, the rest of the process should run smoothly.
What Does Qsymia Cost?
Qsymia Advantage offers pricing set at $98 across all doses. Whether a new patient or continuing treatment, your $98 order includes an additional 2-weeks of Qsymia – 44 days for the price of 30. You also have access to free materials that include nutrition education, physical activity recommendations, and motivational support.
They mention that insurance typically does not cover prescription treatments for obesity, though this may not be absolute. They provide a Medical Necessity Form that can be taken to your doctor visit to initiate a process that may allow from some coverage.
Are There Any Alternatives?
As Qsymia is a medication containing phentermine and topiramate, it can only be obtained through prescription.
Three other weight loss medications have been FDA approved over the last decade, all requiring a doctor’s prescription: Belviq, Contrave, and Saxenda. Though these medications offer different formulations, working closely with your physician is necessary.
While Qsymia stresses the importance of use in conjunction with diet and exercise, diet and exercise alone is likely a good starting place, particularly for those who haven’t done so regularly.
What Are Users Reporting?
Qsymia has a 7.6/10 rating in 326 reviews on drugs.com. Those rating their experience high cite weight loss success – as much as 55 lbs in a year. Even positive reviewers still mentioned experiencing side effects such as dry mouth, tingling in hands and feet, and even depression.
Negative reviews reported mainly a lack of results. One user described less weight loss in 3 months of using Qsymia, compared to one month of counting calories. He also noted needing to get glasses for new-onset blurred vision as a reason for discontinuing use.
The Bottom Line
Qsymia is a prescription-only weight loss medication that, when used in conjunction with diet and exercise, has a proven track record in overweight and obese individuals.
The most common adverse effects are abnormal skin sensations, dizziness, altered taste, insomnia, constipation, and dry mouth, more severe issues can occur.
Regular follow-up with your primary care physician is vital as this medication is not without risk and because dosing must be monitored over time.
The following important adverse reactions are described below and elsewhere in the labeling:
- Fetal Toxicity:
- Elevation in Heart Rate
- Suicidal Behavior and Ideation
- Acute Angle Closure Glaucoma
- Mood and Sleep Disorders
- Cognitive Impairment
- Metabolic Acidosis
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 studies of another drug and may not reflect the rates observed in practice.
The data described herein reflects exposure to Qsymia in two, 1-year, randomized, double-blind, placebo-controlled, multicenter clinical trials, and two Phase 2 supportive trials in 2318 adult patients (936 patients with hypertension, 309 patients with type 2 diabetes, 808 patients with BMI greater than 40 kg/m2) exposed for a mean duration of 298 days.
Common Adverse Reactions
Adverse reactions occurring at a rate of greater than or equal to 5% and at a rate at least 1.5 times placebo include paraesthesia, dizziness, dysgeusia, insomnia, constipation, and dry mouth.
Adverse reactions reported in greater than or equal to 2% of Qsymia-treated patients and more frequently than in the placebo group are shown in Table 3.
Table 3. Adverse Reactions Reported in Greater Than or Equal to 2% of Patients and More Frequently than Placebo during 1 Year of Treatment – Overall Study Population
Reports of paraesthesia, characterized as tingling in hands, feet, or face, occurred in 4.2%, 13.7%, and 19.9% of patients treated with Qsymia 3.75 mg/23 mg, 7.5 mg/46 mg, and 15 mg/92 mg, respectively, compared to 1.9% of patients treated with placebo. Dysgeusia was characterized as a metallic taste, and occurred in 1.3%, 7.4%, and 9.4% of patients treated with Qsymia 3.75 mg/23 mg, 7.5 mg/46 mg, and 15 mg/92 mg, respectively, compared to 1.1% of patients treated with placebo. The majority of these events first occurred within the initial 12 weeks of drug therapy; however, in some patients, events were reported later in the course of treatment. Only Qsymia-treated patients discontinued treatment due to these events (1% for paraesthesia and 0.6% for dysgeusia).
Mood And Sleep Disorders
The proportion of patients in 1-year controlled trials of Qsymia reporting one or more adverse reactions related to mood and sleep disorders was 15.8%, 14.5%, and 20.6% with Qsymia 3.75 mg/23 mg, 7.5 mg/46 mg, and 15 mg/92 mg, respectively, compared to 10.3% with placebo. These events were further categorized into sleep disorders, anxiety, and depression. Reports of sleep disorders were typically characterized as insomnia, and occurred in 6.7%, 8.1%, and 11.1% of patients treated with Qsymia 3.75 mg/23 mg, 7.5 mg/46 mg, and 15 mg/92 mg, respectively, compared to 5.8% of patients treated with placebo. Reports of anxiety occurred in 4.6%, 4.8%, and 7.9% of patients treated with Qsymia 3.75 mg/23 mg, 7.5 mg/46 mg, and 15 mg/92 mg, respectively, compared to 2.6% of patients treated with placebo. Reports of depression/mood problems occurred in 5.0%, 3.8%, and 7.6% of patients treated with Qsymia 3.75 mg/23 mg, 7.5 mg/46 mg, and 15 mg/92 mg, respectively, compared to 3.4% of patients treated with placebo. The majority of these events first occurred within the initial 12 weeks of drug therapy; however, in some patients, events were reported later in the course of treatments. In the Qsymia clinical trials, the overall prevalence of mood and sleep adverse reactions was approximately twice as great in patients with a history of depression compared to patients without a history of depression; however, the proportion of patients on active treatment versus placebo who reported mood and sleep adverse reactions was similar in these two subgroups. Occurrence of depression-related events was more frequent in patients with a past history of depression across all treatment groups. However, the placebo-adjusted difference in incidence of these events remained constant between groups regardless of previous depression history.
In the 1-year controlled trials of Qsymia, the proportion of patients who experienced one or more cognitive-related adverse reactions was 2.1% for Qsymia 3.75 mg/23 mg, 5.0% for Qsymia 7.5 mg/46 mg, and 7.6% for Qsymia 15 mg/92 mg, compared to 1.5% for placebo. These adverse reactions were comprised primarily of reports of problems with attention/concentration, memory, and language (word finding). These events typically began within the first 4 weeks of treatment, had a median duration of approximately 28 days or less, and were reversible upon discontinuation of treatment; however, individual patients did experience events later in treatment, and events of longer duration.
In the 1-year controlled trials of Qsymia, the incidence of persistent treatment-emergent decreases in serum bicarbonate below the normal range (levels of less than 21 mEq/L at 2 consecutive visits or at the final visit) was 8.8% for Qsymia 3.75 mg/23 mg, 6.4% for Qsymia 7.5 mg/46 mg, and 12.8% for Qsymia 15 mg/92 mg, compared to 2.1% for placebo. The incidence of persistent, markedly low serum bicarbonate values (levels of less than 17 mEq/L on 2 consecutive visits or at the final visit) was 1.3% for Qsymia 3.75 mg/23 mg, 0.2% for Qsymia 7.5 mg/46 mg dose, and 0.7% for Qsymia 15 mg/92 mg dose, compared to 0.1% for placebo. Generally, decreases in serum bicarbonate levels were mild (average 1-3 mEq/L) and occurred early in treatment (4-week visit), however severe decreases and decreases later in treatment occurred.
In the 1-year controlled trials of Qsymia, the incidence of persistent low serum potassium values (less than 3.5 mEq/L at two consecutive visits or at the final visit) during the trial was 0.4% for Qsymia 3.75 mg/23 mg, 3.6% for Qsymia 7.5 mg/46 mg dose, and 4.9% for Qsymia 15 mg/92 mg, compared to 1.1% for placebo. Of the subjects who experienced persistent low serum potassium, 88% were receiving treatment with a non-potassium sparing diuretic.
The incidence of markedly low serum potassium (less than 3 mEq/L, and a reduction from pre-treatment of greater than 0.5 mEq/L) at any time during the trial was 0.0% for Qsymia 3.75 mg/23 mg, 0.2% for Qsymia 7.5 mg/46 mg dose, and 0.7% for Qsymia 15 mg/92 mg dose, compared to 0.0% for placebo. Persistent markedly low serum potassium (less than 3 mEq/L, and a reduction from pre-treatment of greater than 0.5 mEq/L at two consecutive visits or at the final visit) occurred in 0.0% of subjects receiving Qsymia 3.75 mg/23 mg, 0.2% receiving Qsymia 7.5 mg/46 mg dose, and 0.1% receiving Qsymia 15 mg/92 mg dose, compared to 0.0% receiving placebo.
Hypokalemia was reported by 0.4% of subjects treated with Qsymia 3.75 mg/23 mg, 1.4% of subjects treated with Qsymia 7.5 mg/46 mg, and 2.5% of subjects treated with Qsymia 15 mg/92 mg compared to 0.4% of subjects treated with placebo. “Blood potassium decreased” was reported by 0.4% of subjects treated with Qsymia 3.75 mg/23 mg, 0.4% of subjects treated with Qsymia 7.5 mg/46 mg, 1.0% of subjects treated with Qsymia 15 mg/92 mg, and 0.0% of subjects treated with placebo.
In the 1-year controlled trials of Qsymia, there was a dose-related increase from baseline, peaking between Week 4 to 8, which declined but remained elevated over baseline over 1 year of treatment. The incidence of increases in serum creatinine of greater than or equal to 0.3 mg/dL at any time during treatment was 2.1% for Qsymia 3.75 mg/23 mg, 7.2% for Qsymia 7.5 mg/46 mg, and 8.4% for Qsymia 15 mg/92 mg, compared to 2.0% for placebo. Increases in serum creatinine of greater than or equal to 50% over baseline occurred in 0.8% of subjects receiving Qsymia 3.75 mg/23 mg, 2.0% receiving Qsymia 7.5 mg/46 mg, and 2.8% receiving Qsymia 15 mg/92 mg, compared to 0.6% receiving placebo.
Drug Discontinuation Due To Adverse Reactions
In the 1-year placebo-controlled clinical studies, 11.6% of Qsymia 3.75 mg/23 mg, 11.6% of Qsymia 7.5 mg/46 mg, 17.4% of Qsymia 15 mg/92 mg, and 8.4% of placebo-treated patients discontinued treatment due to reported adverse reactions. The most common adverse reactions that led to discontinuation of treatment are shown in Table 4.
Table 4. Adverse Reactions Greater Than or Equal To 1% Leading to Treatment Discontinuation (1-Year Clinical Trials)
The following adverse reactions have been reported during post approval use of phentermine and topiramate, the components of Qsymia. 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.
Suicidal ideation, Suicidal behavior
Acute angle closure glaucoma
Increased intraocular pressure
Allergic adverse reactions
Cardiovascular adverse reactions
Elevation of blood pressure, Ischemic events
Central nervous system adverse reactions
Euphoria, Psychosis, Tremor
Reproductive adverse reactions
Changes in libido, Impotence
Bullous skin reactions (including erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis), Pemphigus
Hepatic failure (including fatalities), Hepatitis
Read the entire FDA prescribing information for Qsymia (Phentermine and Topiramate)
The FDA approved the newest prescription weight-loss drug, Qsymia. It’s been 13 quiet years since the last pound-shedding drug Orlistat came out. Qsymia’s approval makes it the second weight-loss drug to hit the market in just a few weeks (Belviq was approved last month). In clinical trials, Qsymia (formerly called Qnexa), from Vivus pharmaceuticals, helped obese individuals lose about 10% of their body weight.
“Drugs like this are crucial to stemming obesity, which is such a vital issue,” says Michael Roizen, M.D., YouBeauty cofounder and chief wellness officer at the Cleveland Clinic. “We have to do something if we are going to get health costs under control. If this drug helps reverse the trend even a little bit, or at the very least raises awareness of the problem, then it can be extremely valuable.”
While patients on Qsymia shed twice as much weight as those who took Belviq, the outlook for the latest newcomer isn’t all rosy. The once-a-day, time-release capsule combines topiramate, an anti-convulsion medication know to cause birth defects, and phentermine, the half of fen-phen that’s still legal.
If this is sounding just a little too familiar, well, it’s not just you.
In Vivus’s first attempt to get Qsymia past regulators back in 2010, the FDA issued a letter expressing concerns over the safety of the two main ingredients. Phentermine has been on the market since 1959, but gained notoriety in the 1990s when fen-phen became all the rage – and then all the scourge. After widespread off-label use – which is to say, your aunt/best friend/boss using it to drop a dress size, as opposed to its official purpose to treat clinical obesity – it came to light that fenfluramine could cause fatal heart valve problems. The FDA pulled the bad fen off the market in the fall of 1997. Qsymia will be dispensed only through pharmacies to try to head off abuse.
Still, that’s not to say that the “good” phen doesn’t raise concerns of its own.
“Medicines and surgery are now cornerstones of obesity treatment,” says YouBeauty Wellness Advisor Beth Ricanati, MD. “The newest kid on the block is Qsymia, and like its pharmacological predecessors, it has side effects. Most of the other obesity medications on the market have been pulled for safety concerns. Currently, the only other FDA-approved drugs on the market are Xenical and Belviq. These are serious drugs with serious side effects. They are for those with significant obesity and who have medical complications as a result.”
During Qsymia’s clinical testing, some patients experienced an increased heart rate, which could lead to other cardiovascular problems, such as increased chance of heart attack or stroke. (Though there is no confirmed direct cause-and-effect.) In order to gain FDA approval, Vivus agreed to conduct further testing to show that Qsymia does not have dangerous cardiovascular side effects. In fact, the company is setting out to show that Qsymia actually improves cardiovascular health, including lowering blood pressure and reducing heart attack and stroke risk.
But these tests won’t start until after the drug hits pharmacy shelves.
The FDA’s initial review also required Vivus to draw up an evaluation and “mitigation strategy” to address the risks of topiramate. Marketed as Topamax to treat epilepsy and to prevent migraines, the drug is known to increase the chance of children born with cleft lips or palates if women take it during the first trimester of pregnancy. Qsymia will come with a pregnancy warning label.
Dr. Roizen contends that it’s too early to tell if women should be wary of the drug and stresses instead its potential: “This could be a powerful aid to help many people get a jumpstart or get past a plateau on the way to overcoming obesity.”
More from YouBeauty.com
QUIZ: Is Your Body Healthy?
Calorie Restriction, Longer Life & A Magic Pill
I’ve been getting comments from the readers, regarding what diet pill I consider the best. In my opinion, the best weight loss products are those which target the hormones and neurotransmitters that govern your body fat.
The functions of these hormones and neurotransmitters is to mobilize the brain and body for action and activities and create a systematic balance of fat and muscle in the body needed for survival. They also provide the appropriate signals to brain and the body’s cells whether you should feel hungry/tired or full/satisfied/energetic.
And that’s why I would recommend Phen375 and Genf20 Plus for weight loss as they target these hormones and neurotransmitters comprehensively..
Read more on my approach towards hormonal weight loss.
In this article, you will read…
- 1. Introduction
- 2. How Does Qsymia Work?
- 3. Is Qsymia the best weight loss pill?
- 1. Topiramate bad reviews
- 2. Problems with Phentermine
- 3. Qsymia’s other disadvantages
- 4. What is Phen375?
- 5. Qsymia does not target all the mechanisms of weight loss
- 6. The idea behind Qsymia is nothing new and there seems to be some marketing hype
- 7. When You Should Definitely Not Take Qsymia?
- 4. Conclusion
- 5. References
The Federal Drug Administration has recently approved two new drugs for assistance with weight loss. Qsymia (pronounced kyoo-sim-ee-uh) is a drug manufactured by Vivus Pharmaceuticals. Arena Pharmaceuticals produces a drug medicine named Belviq, (bel-veek) both drugs have undergone successful clinical trials in benefitting weight loss.
Both Qsymia and Belviq are designed with the intention of aiding obese people with a Body Mass Index, BMI of 30 or higher. A patient with a weight related condition such as high cholesterol, high blood pressure, or type 2 diabetes can be prescribed either drug as long as they have a BMI of 27 or higher. Both drugs are likely to be approved by insurance companies for assisting health conditions related to weight-loss.
Of the two different weight-loss drugs, Qsymia seems to be the more effective, with patients taking Qsymia averaging a weight loss of 9% over those who were issued a placebo.
How Does Qsymia Work?
Qsymia is the combination of two generic drugs: topiramate and phentermine. Topiramate has been known to be primarily used as anti-migraine drug, yet it prevents the absorption of fat in the body. It also provides increasing sensation of fullness. Also, foods have been known to taste less appealing when eaten with topiramate.
Topiramate was originally produced as an anticonvulsant for seizures. Later, topiramate was specifically tested with phentermine, for the purpose of testing as an off-label weight-loss medicine. Topiramate was first approved in 1996 by the FDA.
Phentermine is the other generic drug, and main ingredient in Qsymia. Phentermine is known to have a similar pharmacology to amphetamines, which is often used to treat attention deficit disorder and target the hormone dopamine and neurotransmitter norepinephrine. Phentermine is primarily used as an appetite suppressant helping the patient to stop eating sooner, and eat less.
These neurotransmitters signal a fight or flight response in your body which, in turn, puts a halt to the hunger signal by increasing the blood’s concentration of “leptin”, the neurotransmitter which basically tells the brain that the body does not require food. This results in loss in appetite because your brain doesn’t receive the hunger message.
Here is some more information on leptin:-
Being a combination of two substances that both act as weight loss agents, Qsymia is not exactly similar to Phentermine. The results of clinical trials have shown that Qsymia helps to get rid of 10% of initial weight during the first year already.
The primary reason it got approval was that is happened to be effective and more safe than other phentemrine based diet pills like phen-fen etc.
Is Qsymia the best weight loss pill? Are there better options available?
Here are the primary mechanisms by which Qsymia is supposed to work:-
- reduction of fat absorption in the body
- appetite suppression;
- decrease of insulin levels in the blood;
- reduced risk of: diabetes, hypertension and hyperlipidemia;
- anorexigenic effect (helps to stick to a low-calorie diet)
As you can see the Qsymia possesses quite effective properties and might be able to help people in dealing with obesity by targeting different mechanisms. Experts call it optimal for safe and effective weight loss.
However, there are some bad points and there are better options available. Read on.
1. There are some bad reviews around the use of Topiramate for weight loss like this one.
A user with personal experience with Topiramate says -“Regarding the use of Topamax/topiramate as an ingredient in a weight loss drug, I feel this is irresponsible drug mongering of the worst kind. I think, like most other weight loss pills, this will make some people very sick, and will most likely fail on multiple levels, seeing as it only has an 11-26 percent success rate and it has a metric ton of potential side effects, most of which are very serious. This is an antiepileptic, and shouldn’t be handed out for weight loss. There’s also evidence that, much as is seen with standard weight loss medications, once a person is taken off Topamax they return to their natural weight. Not only is there the risk of side effects and birth defects, but there is also the risk of the drug not working at all. Mainly included as a “fat blocker”, in Qsymia to slow down the absorption of fat in the body cells, the efficiency and safety of Topiramate is questionable.”
According to this study, long term use can even result in verbal learning, retention, and memory loss and for some users, it might be irreversible.
In summary, TPM as a commonly used AED with additional indications for use in migraine headaches, obesity, and psychiatry has verbal learning, retention, and memory loss as major AEs. While these effects are reversible upon discontinuation of the medication, they preclude a significant minority of individuals from continued use. At this time, it is not possible to predict which patients are most vulnerable to such cognitive effects. The mechanism by which Topomax(Topiramate) works to exert its migraine reducing effect is still unknown. It has the potential to influence the production or action of certain neurotransmitters in the brain, suppressing the abnormal activity of the nerves in the brain that cause seizures or preventing the abnormal activity from spreading to other nerves.
Other clinical studies document that it might suppress the nerves directly, thereby making them less likely to fire that prevent severe migraines.
All in all, it’s safety when it comes to weight loss is still in the grey area.
2. Problems with Phentermine
Although Qsymia contains small amounts of phentermine (probably that’s the reason for small results), it still has the side effects of Phentermine.
Appetite suppressants like Qsymia(Phentermine based pills) are currently prescribed by doctors to treat extreme cases of obesity and they help very well in dealing with one of the most common causes of obesity, however they come with side effects.
And there are equally effective, yet safer herbal alternatives to phentermine like Phen375 , which don’t get as much media hype.
Qsymia has all the side effects of Phentermine and Toparimate combined.
3. Qsymia’s other disadvantages
- A doctor’s prescription is required.
- It acts mostly as an “appetite suppressant”, with only mild “thermogenic effect” (increase in burning of calories)
- It is not available online.
- If it does not target your hormones and other factors comprehensively, especially the dopamine and brain-reward response, serotonin, acetylcholine, human growth hormone, and leptin-insulin resistance you might be having, that is why it’s not be going to be greatly effective, no matter how strong an appetite suppressant Phentermine is.
- It has a long list of potential side effects.
Some of well known Qsymia side effects are listed below:
- Restlessness or insomnia
- Constipation or diarrhea
- Elevation in blood pressure
- Difficulty in breathing
- Chest pain
- Excessive Tiredness
- decreased sense of touch
- dry mouth
- unusual thirst
- painful, frequent, or difficult urination
- hair loss
- Loss in verbal learning, retention, and memory
4. What is Phen375?
Phen375 is a herbal diet pill consisting of ingredients and compunds that mimic the actions of phentermine, only without the side effects. The Phen375 plan is a combination of thorough diet plan with a very effective weight loss supplement. These diet plans include an instructional exercise video with the diet plans.
First, Phen375 works as an appetite suppressant so you eat less. This is by the leptin’s appetite suppression mechanism, similar to Phnetermine and Qsymia.
Secondly, it makes the body use its fat reserves for energy and raises your metabolism rate. This is the dopaminergic/cholinergic mechanism and the norepinephrine mechanism.
Finally, ingredients in Phen375 help the body break down fats stored in the body.
This product is effective because of the great combination of five active ingredients.
Dimethypentylamine Hydrochloride, Sympathomimetric Amine, and Trimethylxanthine are three ingredients known to improve AMP, the body’s natural chemical messenger. AMP is needed for many functions in the body including the regulation of metabolism and fat and the sense of being full.
Tongkat Ali is a Malaysian herbal ingredient that suppresses the appetite by enhancing dopamine and norepinephrine neurotransmitters. The diet pill Contrave also primarily makes use of norepinephrine, albiet in a much safer way than Qsymia because Contrave does not contain phentermine and its side effects.
So, in a way Phen375 combines the best of Qsymia and Contrave.
Capsaicin, a chili pepper extract, helps increase metabolism and breaks down fats. It has several studies backing it, like this one.
It is because of these five ingredients that Phen375 is so effective. Some satisfied users even claim that it is like a combination of Ephedra and Phentermine.
Because it has both – the “thermogenic” effect (burning more calories) of Ephedra and “appetite suppressant” effect of Phentermine, that work in synergy, combined in one.
To make it even better, Phen375 has none of the side effects linked with Ephedra and Phentermine diet pills and other supplements.
It also has L-carnitine that increases acetylcholine levels, another very important energy giving neurotransmitter, that plays a role in insulin balancing and secreting more growth hormone which is great for weight loss.
Phen375 is effective in:
- Consuming less calories
- Raising metabolism rates
- Burning the body’s stores of fat
- Preventing muscle loss while dieting and stimulating muscle tissue
- Increasing energy levels
- Burning up to 270 calories
Phen375 is just as effective as the prescription counterpart, Phentermine, with no side effects. The best part is that it is available online without a prescription.
It has other ingredients that improve energy levels.
- Calcium carbonate raises low calcium levels in the body.
- Chromium picolinate helps to increase energy levels and decreases food cravings. It also balances insulin levels and helps to deal with insulin resistance.
- L-carnitine is an amino acid responsible for transporting fatty acids through the body and increasing acetylcholine.
- Citrus aurantium has Synephrine that works as a stimulant, boosting metabolism and energy levels. It helps to burn fat too, although very mildly.
5. Qsymia does not target all the mechanisms of weight loss
Modern research has revealed there might be several complex factors behind your weight gain. Eating more is just one of them, and is more of a “side effect” of gaining weight, rather than the real cause.
When you are making use of a weight loss pill, you are basically trying to transform your body’s composition and definition and it is governed by your brain, via several mechanisms.
However, the most crucial unconscious mechanism seems to be the endocrine or hormonal mechanism.
The hormones govern how much body fat or even muscle you will have.
There are many hormones involved like thyroid, testosterone, estrogen, human growth hormone, leptin, insulin, cortisol etc. and they all should be targeted for long term permanent weight loss.
Other factors resulting in weight gain can range from toxins in the body and colon, hormonal imbalances, aging and genetics.
The endocrine/hormonal factor and leptin-insulin resistance are one of the most crucial factors behind weight loss.
Here are some of those crucial hormones which can be manipulated using psychopharmaceuticals weight loss pills –
- Dopamine, the primary motivation and energy hormone, connected with eating behaviors
- Serotonin, nature’s own appetite suppressant and the primary satisfaction neurotransmitter
- Norepinephrine, the arousal and alertness neurotransmitter and also responsible for fight or flight response
- Human growth hormone, read the scientific study on using HGH for weight loss.
So if you are looking for a weight loss product that works by comprehensively targeting all these mechanisms, Phen375 and Genf20 Plus are multipurpose natural diet supplement that work.
Qsymia seems to target serotonin but very mildly (unlike Belviq which is primarily a serotonin drug). Qsymia does not target acetylcholine.
It definitely does not target the human growth hormone, while Genf20 Plus targets all the three- serotonin, acetylcholine and human growth hormone.
Moreover, Qsymia does not result in dramatic weight loss, for some users it might not be even significant. It is not a magical weight loss pill. Then, there are some bad reviews of Qsymia as a whole.
Didn’t do a thing for me. On day 5 I even doubled both pills. Didn’t do a thing. I found nothing on the Qsymia website that suggests it takes days and days to become effective. In fact if you read carefully there, you will always notice they say Qsymia “may” lower your appetite. Qsymia “may” help you lose weight. Well, if you word it that way – you could say the same thing about banana peels. Also, look at their studies regarding it’s weight loss results. The average weight loss in a year was a whopping 10%, at best, of the participant’s body weight. At least for those who found it effective. Big deal. Do the math. Had I read up on their website, I doubt I would have even given this a shot. – Online user review for Qsymia
Healthy eating habits and an active lifestyle are what work best, and what truly achieves weight loss. Compared to Qsymia, Phen375 and Genf20 Plus are more safe options and can be considered as long term lifestyle pills.
6. The idea behind Qsymia is nothing new and there seems to be some marketing hype.
However, using appetite suppressants like Phentermine and manipulating the levels of hormone “leptin” is a more complicated subject than you might expect, as the mechanisms aren’t always clear.
The best diet pills out there work by influencing several mechanisms simultaneously in your body, and thereby causing weight loss in synergy. In my opinion using Phen375 and Genf20 Plus together is a much better, safe and long term strategy to target all the hormones and neurotransmitters required for weight loss that we mentioned in this article.
Both of these pills are also safe and can be taken long term.
Drugs like Contrave and Qsymia have been reviewed on the Journal of Clinical Psychiatry too, however the free journal is more a platform for advertisements for the drugs companies. Qsymia also seems to be a case of good marketing.
Not all products advertised on Journal of Clinical Psychiatry are effective, mostly because they put out “supplements” bound exactly like the main journal which aren’t necessarily peer-reviewed and can be high-end academic commercials for drug companies. Although you can find some good peer reviewed products in the main paid journal.
7. When You Should Definitely Not Take Qsymia? With all medications, certain people should avoid specific drugs due to personal allergies, dysfunctions, diseases, and personal comfort and well-being. With Qsymia, following are the conditions:-
Those who are allergic to topiramate or phentermine, or medications such as midodrine (Promatine, Orvatine) should not take Qsymia.
Qsymia usually comes in extended release capsules which are to be taken once per day, in the morning. The medication may cause difficulty falling asleep if taken in the evening.
Women who are pregnant or nursing should not take Qsymia. Phentermine and topiramate taken during pregnancy has been known to cause a birth defect called a cleft palate. The baby can develop this very early during pregnancy, so do not take if you are planning on becoming pregnant. Women who are breast-feeding should also not take phentermine and topiramate.
If you have glaucoma, the condition where in increased pressure in the eye can cause vision loss, it’s not likely your doctor will recommend Qsymia to you.
Qsymia is not a prescription recommended to those who have been informed they have an overactive thyroid condition.
If you are taking a monoamine oxidase inhibitor (MAOI), or tranylcypromine (Parnate), it’s not likely your doctor will wish to prescribe Qsymia to you. You should also not take Qsymia if you have taken any MAOI anti-depressants within the past two weeks.
If you are having surgery, even oral surgery, be sure to inform the doctor that you are taking Qsymia. Some experts believe Qsymia has serious potential for heart valve damage because phentermine, one of the two drugs in the combination, was part of the notorious Fen Phen diet drug combo that caused serious heart valve damage in the 1980s and early 90s.
Phentermine and topiramate can prevent you from sweating, making it harder for your body to cool down when it gets hot. Avoid exposure to heat, and drink plenty of fluids. Tell your doctor if you are not sweating as usual.
-High Blood Pressure Medicines
If you are taking blood pressure medications you may have to stop or change dose. Consult with your doctor beforehand.
If you already have kidney stones, or are at risk of getting kidney stones, Qsymia is not for you.
It’s possible that your mental health might change in unexpected ways while taking topiramate. 1 in 500 people have been known to become suicidal during their treatment with topiramates.
It is not recommended to consume alcohol while on Qsymia, as it may cause disruptions in the central nervous system, also known to cause dizziness or create a light-headed feeling.
As with all medications, speak with your doctor before deciding if this medication is right for you. Be sure to inform your doctor if you have any other health conditions, are on any other medications, or supplements.
The best diet pills out there work by influencing several mechanisms simultaneously in your body, and thereby causing weight loss in synergy. In my opinion using Phen375 and Genf20 Plus together is a much better, safe and long term strategy to target all the hormones and neurotransmitters required for permanent and safe weight loss that we mentioned in this article.