FDA to reconsider diet drug that failed to get approval in 2010

Feb 18 2012

With the obesity crisis, many patients are eager for medication help, but the FDA is wary.

The New York Times: U.S. To Review Diet Treatment Once Rejected
Next week, advisers to the Food and Drug Administration will recommend whether the agency should approve the first new prescription diet pill in 13 years. The F.D.A. rejected the drug under review, Qnexa, in 2010, amid safety concerns, and the drug's manufacturer is now presenting additional data to argue its case. ... Through a regulatory loophole of sorts, many obesity doctors prescribe two separate drugs that, when taken together, are essentially the same medicine. The widespread use of the unsanctioned combination reflects the often desperate desire for a medicine to help overcome the nation's epidemic of obesity, doctors and patients say (Pollack, 2/16).

NPR: Weight-Loss Drugs Face High Hurdles At FDA
[T]he FDA rejected Qnexa in 2010 because of concerns about side effects, especially possible heart problems and birth defects. Qnexa's rejection came amid a flurry of failed attempts by drug companies to win approvals of new weight-loss drugs. The setbacks put a spotlight on how the FDA handles these drugs. Even though obesity is at epidemic levels, the FDA hasn't approved any new weight-loss medicines since 1999. ... The FDA has been especially tough on weight-loss drugs because of previous problems with those drugs, such as the diet drug cocktail fen-phen (Stein, 2/17).

In other news on weight issues, Reuters reports on a new study looking at obesity costs:

Reuters: Medicare Expenses Growing Faster For Obese Seniors: Study
Medicare is spending more money every year per person, and each obese beneficiary tacks on an extra $149 a year to that increase, according to a new study. The researchers say chronic conditions associated with obesity, such as high blood pressure and diabetes, are to blame for the steeper climb in health care expenses (Grens, 2/16).