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FDA Panel Recommends Approval For Contrave
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by Jordan Yerman | December 7, 2010 at 02:51 pm
232 views | 0 Recommendations | 3 comments
Orexigen Therapeutics' Contrave: Diet Pill gets FDA Approval Recommendation
Contrave, a diet pill manufactured by Orexigen, is the first weight-loss pill to get a recommendation for approval by an FDA panel. This means that Contrave's benefits may outweigh the potential side effects. It should be pointed out that Contrave did not bring about significant weight loss; the FDA advisory panel asked further studies into the risks of high blood pressure and heart attack associated with the drug. However, the FDA can approve Orexigen's diet pill without the results of those tests.
Contrave is not approved by the FDA yet, however. Should Orexigen's Contrave go all the way, it would be the first prescription diet pill to win FDA approval in ten years. Contrave's competitors, Qnexa and lorcaserin, manufactured by Vivus and Arena Pharmaceuticals respectively, have been rejected by the FDA.
The panel of experts voted 13 to 7 Tuesday for Contrave's approval, and 11 to 8 that additional studies be conducted on heart risks. Experts had voiced safety concerns on the drug, but determined the benefits outweigh the risks.
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Most RecentMost Recommended Comments (3)
at 13:21 on December 9th, 2010
Lorquess and Meridia were recently pulled for damaging health effects. Is it really worth the risk? There is an interesting article at the Health Journal Club that makes the case that the healthiest thing to do is simply not eat anything that wasn't a food 100 years ago.healthjournalclub.blogspot.com/2010/01/100-year-diet.htmlCertainly gets rid of the trans fats, artificial food colors, bleached flour, transgenic frankenfoods etc, likely would lead to healthy weight loss as well.
at 15:51 on December 9th, 2010
Lorqess was never actually approved but your right with Meridia. I also think a crazy thing is, is that apparently the FDA panel wants to do some testing AFTER it is approved as opposed to BEFORE it is approved. With so many health concerns that have been raised with d pills perhaps they should be a little more careful. But then some argue that with all the health concerns there are being obese, perhaps get the pill out quickly.
at 20:13 on January 23rd, 2011
Contrave is a combination of two relatively safe drugs that already have FDA approval. If you look at the safety data of the clinical trials, the relative risks of taking the drug are quite minor compared to the health risks of continued obesity and depression. The patients that had the heart complications, cannot be blamed on Contrave. These people were already obese, and it is unknown to the public what other health risks ie, cholesterol levels etc were also present. At least one patient ignored chest pain for almost 14 days before his cardiac event. Obviously, other factors were at work in that case. While Contrave might not be a panacea for obesity, I think that Contrave, combined with nutritional improvements and a regular exercise routine, will be an excellent tool in the battle of obesity. And while further heart studies may be warranted, there is no reason to delay FDA approval, and the opportunity for patients (35% of the population) to potentially benefit from this drug.It is important to note that for the first time, children are not necessarily expected to outlive their parents, due to the overwhelming obesity epidemic rampant among young people today. A very, very sad fact.