Alli Damage Control: Maybe it’s those extra pounds?

September 3rd, 2009. By AbiK

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 early communications on a drug go; once the FDA begins to watch a drug more closely, they typically advise continued use of the drug as directed until they’ve had a chance to complete their study and make a determination on the drug’s overall safety.

But no corporate PR department is going to leave it at that—not when there’s opportunity to throw some additionally supportive evidence in to bolster their position. So the GSK release went on to say:

To put FDA’s communication into perspective, there is a high prevalence of liver disease in people who are overweight. It is estimated that about 15-20% of obese people have liver injury due to excessive fat in the liver♦. Additionally, in obese individuals, gradual weight loss can prevent injury or improve liver function.

♦Preiss, D., Sattar, N. Non-alcoholic fatty liver disease: An overview of prevalence, diagnosis, pathogenesis and treatment considerations. (2008) Clinical Science, 115 (5-6), pp. 141-150.

Translation: uh, maybe those adverse liver problems are because, well, you’re overweight. And see, there’s a scientific study out there that supports this! See?!? See?!?

I’m exaggerating, of course. But that’s the message. So until more information is provided, you’ve got some Alli and Xenical adverse events being reported and a company that stands by its product. Just another day in big pharma land! We’ll be watching this one…

Tags: Alli, Orlistat, orlistat-side-effects-orlistate-liver-damage-alli, Xenical

This was posted on Thursday, September 3rd, 2009 at 1:18 pm and is filed under Drugs/Medical . Feel free to respond, or trackback. Read our comments policy.