6 ms·
> Even if these drugs have risks, the risks of obesity are likely much higher. "Likely", nice weasel word there. In fact, sibutramine was pulled after the SCOU
by losvedir 16y ago
> Even if these drugs have risks, the risks of obesity are likely much higher.
"Likely", nice weasel word there. In fact, sibutramine was pulled after the SCOUT trial showed that the risks of obesity were not higher. The cardiovascular risks of the drug more than offset the decresae in risks from lower weight.
Lorcaserin was barely efficacious, and had a cancer signal.
Qnexa was very efficacious, but had even more serious side effects. One serious one-two punch is that it makes women much more fertile because of the hormonal effects of weight loss (in the clincial trial something like 20 women got pregnant despite double birth control protection), and at the same time contains topiramate, a Pregnancy Category C drug known to cause birth defects.
You'll get no argument from me that the FDA is very risk averse (and I think there are several drugs rejected this year that should have been approved, e.g. pirfenidone for IPF), but I think you're wrong that the FDA should have approved these obesity drugs. As you say, obesity is a big problem in the US, which means lots and lots of people are going to take any drugs once they're approved. Such drugs have to be incredibly safe or there will be lots of problems.
The next obesity drug to come up for FDA approval is Orexigen's Contrave, and we'll see what happens there.