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Agency Warns of Increased Risk for Oral Birth Defects

July 17, 2012 -- For the second time in less than a month, the FDA has approved a new prescription weight loss drug.

Qsymia, developed by California-based Vivus Inc., combines two already prescribed medications -- the stimulant phentermine and the anti-seizure drug Topamax (topiramate) -- in a controlled-release pill that is taken once a day.

Last February, an FDA advisory panel overwhelmingly voted to recommend the drug, formerly called Qnexa, for promoting weight loss in people who are obese, with the exception of pregnant women.

"Obesity is one of the biggest problems we are facing in health care, and we need more tools to help people lose weight," says diabetes specialist Abraham Thomas, MD, who served on the FDA advisory panel. "But these drugs are not a replacement for lifestyle changes."

Qsymia's approval came as an addition to a reduced-calorie diet and exercise.

It is approved for use in adults with a body mass index (BMI) of 30 or above, which is considered obese, or a BMI of 27 or greater (overweight) with at least one weight-related condition, such as high blood pressure, type 2 diabetes, or high cholesterol.

FDA Asks for Cardio Studies, Pregnancy Tests

Just as with Belviq (lorcaserin), the weight loss drug that was approved last month, federal officials will require post-marketing studies to look for evidence of increased heart disease or stroke risk in people who take Qsymia.

Women who might become pregnant are also being advised to use effective birth control while on the drug, and monthly pregnancy tests are also being recommended, along with an initial negative pregnancy test before starting the medication.

Fetal exposure to topiramate has been linked to an increased risk for cleft lip, with or without cleft palate.

Qsymia also must not be used in people with glaucoma or hyperthyroidism. And it's not recommended for people with recent or unstable heart disease or stroke.

Patients are recommended to have regular monitoring of heart rate when starting the drug or increasing the dose.

The FDA approved Qsymia with a Risk Evaluation and Mitigation Strategy (REMS), designed to educate prescribers and their patients about the increased risk of birth defects associated with first trimester exposure to the drug, along with the need to avoid pregnancy while taking it.

And the drug will only be dispensed through specially certified pharmacies.

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