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FDA Approves Two New Weight-Loss Drugs
July 27, 2012
After roughly 13 years without a new weight-loss drug hitting the market, the US Food and Drug Administration has recently approved two new medicines for weight management.
Belviq (lorcaserin hydrochloride) was approved on June 27, 2012 for use, in conjunction with a healthful diet and physical activity, in adults with a body-mass index of 30 or more (considered to be obese) or those with a body-mass index of 27 or more (considered to be overweight) with at least one weight-related condition such as Type 2 diabetes or high blood pressure.
Belviq works by activating a receptor in the brain that increases levels of serotonin, which may help a person to eat less and to feel full after smaller amounts of food. The drug is taken in a dose of 10 milligrams twice a day. (Doses of this medicine should not exceed 10 milligrams twice a day.)
In trials with Belviq, roughly 38% of people with Type 2 taking the drug lost 5% of their body weight, compared to 16% of people with Type 2 being treated with a placebo (inactive treatment). In those without diabetes, approximately 47% of people taking the drug lost 5% of their body weight, compared to 23% of those taking placebo. The labeling for this medicine recommends that those who do not lose 5% of their body weight after 12 weeks of using the drug discontinue use, as they are unlikely to lose significant amounts of weight with continued treatment.
This medicine should not be taken by pregnant women or by people who are taking drugs linked to valvular heart disease, such as Dostinex. Caution should be used in those who are taking certain medicines for depression, migraine, colds, or mood, anxiety, psychotic, or thought disorders; men with conditions that predispose them to erections lasting more than four hours; and men who have a deformed penis.
The most common side effects of Belviq in people with diabetes are low blood glucose, headache, back pain, cough, and fatigue. In those without diabetes, the most common side effects are headache, dizziness, fatigue, nausea, dry mouth, and constipation.
Qsymia (phentermine and topiramate extended-release) was approved on July 17, 2012, for use, in conjunction with a healthful diet and physical activity, in adults with a body-mass index of 30 or more (considered to be obese) or those with a body-mass index of 27 or more (considered to be overweight) with at least one weight-related condition such as Type 2 diabetes or high blood pressure.
Qsymia combines two medicines: Appetite suppressant phentermine (the safe portion of the unsafe fen-phen diet drug combination) is thought to work by triggering the release of norepinephrine, which increases blood levels of the appetite-suppressing hormone leptin. Topiramate is an antiseizure and migraine drug that causes weight loss by increasing feelings of fullness and calorie burning and making foods taste less appealing. The recommended daily dose of Qsymia contains 7.5 milligrams of phentermine and 46 milligrams of topirimate extended-release, while the highest dose, available for a select group of people, contains 15 milligrams of phentermine and 92 milligrams of topirimate extended-release.
In trials with Qsymia, roughly 62% of people at the recommended dose and 69% of people at the highest dose lost at least 5% of their body weight, compared to 20% of people taking placebo. Those who have not lost at least 3% of their body weight after 12 weeks on Qsymia should be evaluated to determine whether to discontinue use of the medicine or to progress to the higher dose. Those who do not lose 5% of their body weight after 12 weeks of using the higher dose should discontinue use, as they are unlikely to lose significant amounts of weight with continued treatment.
Qsymia can cause birth defects and should not be used by women who are pregnant; women of childbearing age must use effective birth control while taking Qsymia. The medicine also should not be used by people who have glaucoma, those who have an overactive thyroid, those who are taking a type of antidepressant known as MAOIs, or people who are allergic to either of the component medicines.
The most common side effects of Qsymia are tingling of hands and feet, dizziness, altered taste sensation, insomnia, constipation, and dry mouth.
For more information about Belviq, see the press release on the FDA Web site. And to learn more about Qsymia, see the press release on the FDA Web site or see official Qsymia site. And for a side-by-side comparison of the two medicines, see this piece from WebMD.
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