The FDA advisory Panel has voted in favor of approving the diet drug Contrave for treating obesity.
In what is being heralded as a diet pill breakthrough for some is yet another diet pill offering up an unproven safety record for others. The pill in question is called Contrave, a combination of Naltrexone and Bupropion, two existing FDA approved medications mixed into one pill. The result is weight loss that is significant enough that it has achieved an FDA advisory panel vote of 13-7 in favor of approving it. But is there more than what meets the eye to this supposed answer to obesity.
The FDA has recently been quit cautious when reviewing obesity medication. The reason is simple, all too often there are side effects that are reported during testing phases that just do not jive well enough to make them safe for the public. There does not seem to be too much of a problem creating something that will indeed be effective, but at what cost. In the case of Contrave, the FDA advisory panel figured that the side effects to benefits ratio warranted an approval vote. The FDA will then deliberate on their findings at the end of January 2011 to determine its fate. In most cases, the FDA will go ahead and approve a drug that has been deemed approvable by its advisory panel. However this is not always the case. What I have heard however is that in order to keep a close eye on the effects of Contrave that there will most likely be a post approval test that will be required in order to ensure its safety.
I question this sort of behavior, perhaps it is just as a precautionary principle but it sounds to me like they don’t really know the safety effects over the longer term. This could be a little concerning for some because it sounds like the safety is still in question. I suppose it is better to find out that a thousands of people where damaged as apposed to millions. On the other hand, it is more likely just a test that could probably be avoided but is placed there to be extra safe, kind of like creating a new apple and having a long term study to determine the safety of it when nothing really needs to be done. One thing that I feel Contrave has on its side is that the two drugs Bupropion and Naltrexone have been around for years and have been used on patient’s long term, just not together. But this is not an entirely new drug with an unseen chemical make up.
