Qysmia Diet Drug Hits Market Amid Pregnancy Risks, Other Concerns

The new weight loss drug Qsymia was introduced to the market this week, despite the risk of birth defects from topiramate, one of the active ingredients, and other safety concerns that caused the FDA to delay approval of the prescription medication. 

Originally proposed under the brand named Qnexa, Vivus, Inc. is now marketing the new diet drug as Qsymia, after gaining FDA approval in July.

Qsymia contains a combination of phentermine, an amphetamine, and topiramate, an antiseizure drug that is the active ingredient in Topamax.

Phentermine was the “Phen” in Fen Phen, which was recalled due to heart problems, and concerns emerged last year about the risk of topiramate side effects causing women using Topamax during pregnancy to have babies with cleft palate and cleft lip birth defects.

Due to safety concerns with Qsymia, the drug is only approved for people who are clinically obese or with a body mass index greater than 27 who have also been diagnosed with other weight-related health problems, such as diabetes or high blood pressure.

The pill, whose name was changed to avoid confusion with other drugs on the market, will only be available through mail order, to prevent doctors from dispensing it to patients directly.

This is only the second weight loss drug approved by the FDA in more than a decade, but its approval came only after it was rejected once and then delayed due to safety concerns. Besides the concerns over birth defects, some are worried that it could cause heart problems as well.

Weight loss drugs have been plagued by serious side effects, and the last new prescription medication to help dieters was Roche’s Xenical, which was introduced in 1999

Xenical (orlistat 120mg) is a prescription medication that was approved by the FDA in 1999. The lower dose Alli (orlistat 60mg) is an over-the-counter weight-loss drug that was approved in 2007. Both drugs are marketed by GlaxoSmithKline, PLC, though Xenical is manufactured by Roche.

The FDA issued a liver injury warning for Xenical and Alli in May 2010.  Last April, Public Citizen, a consumer watchdog group, petitioned the FDA to recall Alli and Xenical from the market.