Qnexa, a diet pill that some researchers say increases risks of birth defects and heart problems, is getting a second shot at making its way to the market. After rejecting the drug in 2010, the Food and Drug Administration will review Qnexa again Wednesday.
The New York Times reports there is pressure on the FDA to green-light the drug because the medical community needs more ammunition to combat obesity. The agency is concerned that the drug could go into widespread use and thus cause problems in a massive segment of patients.
A committee of advisers meeting with the FDA will help the agency determine whether a clinical trial should be conducted before or after the drug is approved for the public. If the FDA decides to keep Qnexa in check before a study is completed, it could delay the drug’s release for years.
Vivus, the company that owns the drug, has proposed releasing it but finding a way to withhold it from some women who are capable of having children.
These sorts of decisions are part of the reason why the FDA makes the big bucks. Hopefully the agency will ensure that the drug will be able to help those who need it without hurting them, whenever it becomes available.
Side Effects of Diet Pill Still Concern Regulators [The New York Times]