In response to health advocates pushing for new solutions to combat obesity, the U.S. Food and Drug Administration has now approved Belviq and Qsymia, the first new prescription diet drugs approved by the FDA in 13 years.
Both these drugs have been approved for use in adults with a body mass index (BMI) of 30 or greater (obese) or adults with a BMI of 27 or greater (overweight) who have at least one weight-related condition such as high blood pressure (hypertension), type 2 diabetes, or high cholesterol (dyslipidemia). Please call us if you have any questions.
Dr. Girouard is in agreement with Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research, when she says, "obesity threatens the overall well being of patients and is a major public health concern. Belviq or Qsymia, used responsibly in combination with a healthy lifestyle that includes a reduced-calorie diet and exercise, will provide another treatment option for chronic weight management in Americans who are obese or are overweight and have at least one weight-related comorbid condition."
July 17, 2012 - The U.S. Food and Drug Administration today approved Qsymia (phentermine and topiramate extended-release) as an addition to a reduced-calorie diet and exercise for chronic weight management. Qsymia is a combination of two FDA-approved drugs, phentermine and topiramate, in an extended-release formulation. Phentermine is indicated for short-term weight loss in overweight or obese adults who are exercising and eating a reduced calorie diet. Topiramate is indicated to treat certain types of seizures in people who have epilepsy and to prevent migraine headaches.
The safety and efficacy of Qsymia were evaluated in two randomized, placebo-controlled trials that included approximately 3,700 obese and overweight patients with and without significant weight-related conditions treated for one year. All patients received lifestyle modification that consisted of a reduced calorie diet and regular physical activity.
Results from the two trials show that after one year of treatment with the recommended and highest daily dose of Qsymia, patients had an average weight loss of 6.7 percent and 8.9 percent, respectively, over treatment with placebo. Approximately 62 percent and 69 percent of patients lost at least five percent of their body weight with the recommended dose and highest dose of Qsymia, respectively, compared with about 20 percent of patients treated with placebo.
The recommended daily dose of Qsymia contains 7.5 milligrams of phentermine and 46 mg of topiramate extended-release. Qsymia is also available at a higher dose (15 mg phentermine and 92 mg of topiramate extended-release) for select patients. The most common side effects of Qsymia are tingling of hands and feet (paresthesia), dizziness, altered taste sensation, insomnia, constipation, and dry mouth. Qsymia is marketed by Vivus Inc. in Mountain View, California.
Patients who did not lose at least three percent of their body weight by week 12 of treatment with Qsymia were unlikely to achieve and sustain weight loss with continued treatment at this dose. Therefore, response to therapy with the recommended daily dose of Qsymia should be evaluated by 12 weeks to determine, based on the amount of weight loss, whether to discontinue Qsymia or increase to the higher dose. If after 12 weeks on the higher dose of Qsymia, a patient does not lose at least five percent of body weight, then Qsymia should be discontinued, as these patients are unlikely to achieve clinically meaningful weight loss with continued treatment.
Qsymia must not be used during pregnancy because it can cause harm to a fetus. Data show that a fetus exposed to topiramate, a component of Qsymia, in the first trimester of pregnancy has an increased risk of oral clefts (cleft lip with or without cleft palate). Females of reproductive potential must not be pregnant when starting Qsymia therapy or become pregnant while taking Qsymia. Females of reproductive potential should have a negative pregnancy test before starting Qsymia and every month while using the drug and should use effective contraception consistently while taking Qsymia.
Qsymia must not be used in patients with glaucoma or hyperthyroidism. Qsymia can increase heart rate; this drug's effect on heart rate in patients at high risk for heart attack or stroke is not known. Therefore, the use of Qsymia in patients with recent (within the last six months) or unstable heart disease or stroke is not recommended. Regular monitoring of heart rate is recommended for all patients taking Qsymia, especially when starting Qsymia or increasing the dose. .
The FDA approved Qsymia with a Risk Evaluation and Mitigation Strategy (REMS), which consists of a Medication Guide advising patients about important safety information and elements to assure safe use that include prescriber training and pharmacy certification. The purpose of the REMS is to educate prescribers and their patients about the increased risk of birth defects associated with first trimester exposure to Qsymia, the need for pregnancy prevention, and the need to discontinue therapy if pregnancy occurs. Qsymia will only be dispensed through specially certified pharmacies. Vivus Inc. will be required to conduct 10 postmarketing requirements, including a long-term cardiovascular outcomes trial to assess the effect of Qsymia on the risk for major adverse cardiac events such as heart attack and stroke.
FDA Approves Belviq To Treat Some Overweight Or Obese Adults
June 27, 2012 - The U.S. Food and Drug Administration today approved Belviq (lorcaserin hydrochloride), as an addition to a reduced-calorie diet and exercise, for chronic weight management.The drug is approved for use in adults with a body mass index (BMI) of 30 or greater (obese), or adults with a BMI of 27 or greater (overweight) and who have at least one weight-related condition such as high blood pressure (hypertension), type 2 diabetes, or high cholesterol (dyslipidemia).
Belviq works by activating the serotonin 2C receptor in the brain. Activation of this receptor may help a person eat less and feel full after eating smaller amounts of food.
The safety and efficacy of Belviq were evaluated in three randomized, placebo-controlled trials that included nearly 8,000 obese and overweight patients, with and without type 2 diabetes, treated for 52 to 104 weeks. All participants received lifestyle modification that consisted of a reduced calorie diet and exercise counseling. Compared with placebo, treatment with Belviq for up to one year was associated with average weight loss ranging from 3 percent to 3.7 percent.
About 47 percent of patients without type 2 diabetes lost at least 5 percent of their body weight compared with about 23 percent of patients treated with placebo. In people with type 2 diabetes, about 38 percent of patients treated with Belviq and 16 percent treated with placebo lost at least 5 percent of their body weight. Belviq treatment was associated with favorable changes in glycemic control in those with type 2 diabetes. The approved labeling for Belviq recommends that the drug be discontinued in patients who fail to lose 5 percent of their body weight after 12 weeks of treatment, as these patients are unlikely to achieve clinically meaningful weight loss with continued treatment.
Belviq should not be used during pregnancy. Treatment with Belviq may cause serious side effects, including serotonin syndrome, particularly when taken with certain medicines that increase serotonin levels or activate serotonin receptors. These include, but are not limited to, drugs commonly used to treat depression and migraine. Belviq may also cause disturbances in attention or memory.
In 1997, the weight-loss drugs fenfluramine and dexfenfluramine were withdrawn from the market after evidence emerged that they caused heart valve damage. This effect is assumed to be related to activation of the serotonin 2B receptor on heart tissue. When used at the approved dose of 10 milligrams twice a day, Belviq does not appear to activate the serotonin 2B receptor.
Heart valve function was assessed by echocardiography in nearly 8,000 patients in the Belviq development program. There was no statistically significant difference in the development of FDA-defined valve abnormalities between Belviq and placebo-treated patients. Because preliminary data suggest that the number of serotonin 2B receptors may be increased in patients with congestive heart failure, Belviq should be used with caution in patients with this condition. Belviq has not been studied in patients with serious valvular heart disease.
The most common side effects of Belviq in non-diabetic patients are headache, dizziness, fatigue, nausea, dry mouth, and constipation, and in diabetic patients are low blood sugar (hypoglycemia), headache, back pain, cough, and fatigue. Belviq is manufactured by Arena Pharmaceuticals GmbH of Zofingen, Switzerland, and distributed by Eisai Inc. of Woodcliff Lake, N.J.TOP Which One Is For Me?
Since these drugs are brand new and not available as yet in our clinics, we do not have our own patieint specific results for comparison to share with you. However, we can share with you that both drugs do help some people lose weight; neither drug is for everyone; and the two drugs are quite different. We will update you as information becomes available.
The following links are for copies of the official FDA News Releases for both drugs in English and Spanish:
With some two-thirds of Americans considered overweight or obese, researchers now realize that obesity itself is a disease. Obesity greatly increases all kinds of other serious medical risks, from diabetes to heart disease to depression, and the related cost to public health and the economy is skyrocketing. Even though both Qsymia and Belviq carry risks, FDA advisory panels thought long and hard about recommending approval. But the panels were swayed by what most members saw as the much greater risk of untreated obesity. The following FAQ have been made available through information from WebMD and the drug manufacturers.
Frequently Asked Questions
- How do you pronounce Qsymia? Belviq?
- Vivus Pharmaceuticals says you should pronounce Qsymia this way: kyoo-sim-EE-uh.
Arena Pharmaceuticals says you should pronounce Belviq this way: BEL-VEEK.
- Do Qsymia and Belviq work the same way?
- No. Qsymia and Belviq are very different drugs.
Qsymia combines two currently approved drugs. One is the appetite suppressant phentermine, the safer "phen" part of the infamously unsafe fen-phen diet drug combo. Phentermine is thought to suppress appetite by triggering release of the brain chemical norepinephrine. This suppresses the appetite by increasing blood concentrations of the appetite-regulating hormone leptin. The other half of Qsymia is the seizure/migraine drug topiramate. Topiramate causes weight loss in several ways, including increasing feelings of fullness, making foods taste less appealing, and increasing calorie burning. Qsymia is scheduled as a controlled substance because of its phentermine component.
Belviq causes weight loss by turning on a specific switch that increases levels of the brain messenger serotonin. At dosages intended for weight loss, it does not significantly turn on slightly different serotonin switches responsible for the effects of hallucinogens (such as LSD) and addictive drugs of abuse. Higher doses may trigger these switches, which is why the DEA likely will schedule Belviq as a controlled substance.
- When will Belviq and Qsymia be available?
- Qsymia will be available sometime after September 2012.
Belviq won't be available until early-to-mid 2013.
- Which works better, Belviq or Qsymia?
- There's no way to know for sure. Qsymia and Belviq have never been tested in a head-to-head clinical trial. Though these numbers cannot be used to compare the two drugs, as the clinical trials had different designs, in the independent placebo-controlled clinical trials that led to each drugs approval:
- People taking Belviq had an average weight loss that was 3% to 3.7% greater than people taking placebo.
- After taking Belviq for one or two years, some 47% of people without diabetes lost at least 5% of their body weight. Only 23% of patients taking an inactive placebo lost this much weight.
- People taking Qsymia for up to one year had an average weight loss of 8.9% over those taking an inactive placebo.
- 70% of people taking Qsymia lost at least 5% of their body weight. Only 20% of patients taking an inactive placebo lost this much weight.
- How long would I have to keep taking Qsymia or Belviq?
- People are supposed to keep taking Qsymia or Belviq for the rest of their lives, unless they develop side effects or have other reasons to stop.
- If I take Belviq or Qsymia, do I still have to diet and exercise?
- Absolutely. In clinical trials, the drugs were effective only when given along with a balanced diet and exercise.TOP
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