FDA Approves Qsymia Diet Drug, with Warnings About Side Effects

Posted by Eric ChaffinJuly 31, 2012 9:45 AM

Most of us know that our country is in the grips of an obesity epidemic. Doctor recommended diet and exercise programs have not controlled the problem, so pharmaceutical companies are hard at work coming up with other solutions. Last month, the FDA approved Belviq (lorcaserin) as a weight-loss drug for those with a body mass index (BMI) of 30 or greater. More recently, the FDA approved Qsymia (phentermine and topiramate extended-release) for chronic weight management in addition to a reduced-calorie diet and exercise.

These drugs come with potentially serious side effects, and it seems like once again the public is taking part in a giant experiment. For example, federal officials are requiring post-marketing studies to look for evidence of increased heart disease or stroke risk in those who take Qsymia.

Concerns About Cardiovascular Risks

It was only about a year-and-a-half ago that the FDA rejected manufacturer Vivus first petition to approve Qsymia (pronounced kyoo sim EE uh). Among other things, the agency was concerned that the drug could increase the risk of heart attack and stroke. The FDA rejected Belviq in an earlier request for approval because of similar concerns.

Experts believe the agency has changed their position because of new data presented by the manufacturers, but also because of the ever-increasing health dangers associated with obesity. According to the Centers for Disease Control and Prevention, more than one-third of U.S. adults are obese, which can lead to heart disease, stroke, type 2 diabetes, and certain types of cancer.

In pre-approval studies, patients taking Qsymia who also made lifestyle changes lost an average of about 10 percent of their body weight after one year. Studies showed no evidence of increased cardiovascular risks. Critics note, however, that a similar drug, Fen-Phen, combined phentermine (an appetite suppressant) with fenfluramine, and was later taken off the market because of links to heart valve problems.

Concerns About Birth Defects

This time, the drug combines phentermine with topiramate, also known as Topamax, a drug currently prescribed to help control epileptic seizures and migraine headaches. In early 2011, the FDA warned that taking Topamax during pregnancy increases the risk of oral cleft birth defects such as cleft lip and palate. An analysis of the data shows that the risk is up to 16 times higher among women who take the drug than those who do not.

Many feel the warning came late, particularly women who took the drug in years past without the knowledge of the risks and gave birth to babies with birth defects. Hundreds of Topamax lawsuits were filed before awareness increased on the issue, but now the FDA has changed the classification from category C to category D risk, reflecting human data that confirms the fetal risk.

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FDA Approves Qsymia Diet Drug, with Warnings About Side Effects