The FDA approved QSYMIA, the Vivus compound for the treatment of obesity. As regular readers of this site will know, I have been opining for many months that I didn’t think this would happen soon, if at all.
There has never been a doubt in anyone’s mind that QSYMIA (nee QNEXA) was the most effective of the diet drugs that have been submitted to the FDA. The issue has always been safety. For some it was the cardiovascular risk particularly in light of the recent negative experience with fen-phen. For others, it was the potential for neurological problems. While a concern, I never felt these potential problems would be the obstacle to approval. For me, it was the fact that this was an acknowledged teratogen and a large part of the population of patients who would use this drug would be women of child bearing potential.
The basis for my concern goes back to the very foundation of the modern FDA concern for safety. The Food and Drug Amendments of 1962 were a response to the thalidomide tragedy in Europe. The US was spared because the drug was not approved here. The 1962 Amendments were enacted to prevent such a tragedy from happening here. Some have said that since that time, the FDA has overemphasized safety, often criticized for keeping life saving drugs off the market because of a potential for harm. With the approval of QSYMIA, those critics are silenced – for now.