Obesity Drug Voted Down by FDA Panel

The Food and Drug Administration (FDA) holds a lot of power over drug manufacturers, and the makers of a new diet pill were disappointed Thursday, July 15. That is when an advisory panel voted 10 to 6, not to recommend a new pill that is supposed to combat obesity.

Consumer Affairs reports that the drug called Qnexa, made by Vivus, would have been available by prescription only as a weight control aid.

The FDA does not have to accept the recommendation of the advisory panel, but usually does. The experts voting against Qnexa noted the potential side effects such as psychiatric problems, birth defects, and an increased heart rate. A panel member from the University of Colorado said that no one wants to conduct a public health experiment on the population at large.

The FDA and Vivus may have dodged a bullet on that one. While obesity is a national dilemma and carries with it a host of medical problems, companies that develop weight control products, hoping to cash in on the national obsession, have found themselves at the receiving end of wrongful death and defective product lawsuits in Florida and throughout the United States.

Does everyone remember the weight control drug fen-phen? It was taken off the market about 13 years ago because of its link to heart damage. Qnexa contains one part of the fen-phen formulation – phentermine. While that drug has been allowed to stay on the market, do we really need a repeat of that debacle?

The Vivus CEO says he will not give up on the drug. That is because with only four states in the country with an obesity rate under 20 percent, any weight loss drug has the potential to become a blockbuster, even if it is later found to be dangerous.

No one wants to understand that weight loss takes a commitment and a plan, usually involving exercise and diet. Taking a pill is much easier, but in the long run, it has not been easy for those permanently injured by the dangerous drug fen-phen.