After recently posting about the FDA’s early communication on its safety review of Alli (aka orlistat) things seemed kind of quiet. The communication indicated that there had been reports of liver-related serious adverse events.
The Alli adverse event reports were low in numbers—especially when you consider that it was over a 9 year period. Regardless, there have been serious reports of liver injury. And once word came out about them via the FDA, Alli manufacturer GSK needed to respond.
So, GSK has begun its damage-control campaign—starting with yesterday’s press release that was carried on reuters.com with the following headline: “FDA states consumers should continue to use Alli”. That is a true statement—but it’s also standard operating procedure as far as FDA Read the rest of this entry »