Does it Work? - Orlistat/Xenical/Alli under FDA probe for possible liver damage

The Food and Drug Administration announced today that regulators are assessing at least 32 reports of liver problems between 1999 and 2008 in patients taking the weight-loss drug orlistat, sold as a prescription drug Xenical and more recently, as an over-the-counter medication called Alli.

Of the 32 reports of liver problems the FDA has in hand, 27 patients were hospitalized and six suffered liver failure. In an "early communication" of a drug safety review, the FDA said it will also review additional data on "suspected cases of liver injury" submitted by drug firms that make and market orlistat in its branded and generic forms. Orlistat was originally marketed, and still is, by Roche Pharmaceuticals as Xenical, a prescription drug. The medication, which blocks the absorption of fat through the digestive tract, gained approval as an over-the-counter drug in 2007, and is marketed as Alli by GlaxoSmithKline. Orlistat has been approved for use in 100 countries.

The rest of the article is located at:
http://latimesblogs.latimes.com/booster_shots/2009/08/fda-studying-reports-of-liver-failure-with-weight-loss-drug-orlistat.html

I don't know if this has been elevated but I was at Target today and they had pulled it off their shelves.

I've been expecting this - especially after the medication went OTC, in the form of Alli.

When Alli came out, I told my husband that I suspected that people would be more likely to abuse the drug (taking significantly more than prescribed or directed) after it went OTC. It's happened with many other drugs, including tylenol. There's been a push in some sectors recently to return tylenol to prescription status, because of the number of deaths and severe organ damage that occur every year from misuse.

Many people falsely believe that over-the-counter medications are essentially overdose proof, or that at least the maximum "safe" dosage is many times higher than stated on the information sheets that come with the medication. I know people personally who double their Alli dose because Alli is half the dose of prescription Xenical. Just as I've seen people take five or six tylenol or wash it down with alcohol (when I tell them how dangerous that is, they laugh and say it's never hurt them yet - and I tell them that by the time they "feel" organ damage occuring, it will be too late!)

I suspect that there are both Alli and Xenical users who believe that "if one is good, three are better."

It will be difficult to determine how many of the people with liver damage, used the drug as prescribed, because many people will be reluctant to admit that they did something so stupid (especially if they're seeking monetary damages).

Hi, I am on the Alli pill, I take them exactly as prescribed and not at all if I don't eat a meal with more than 5gms of fat, I hope I don't need to stop them because of them taking the pills off the shelves, thanks, LIz

The things I've read don't make it clear as to whether the liver damage cases are a result of the OTC Alli or not. The articles just say Orlistat which can be either Alli or Xenical.

I think it is a bit concerning though that a drug that claims to be perfectly safe and only operates on digestion of fatty foods is causing liver damage.

I'm also not sure what it means for Alli. They may decide to pull Orlistat completely or they may just decide to pull Alli and keep Xenical as is or they could lower the dosage of Xenical and make it prescription only.

Well the key here is "are they taking it as prescribed?" If the answer is No, then there's no reason for them to pull the drug from the market. People are abusing it, so they're suffering consequences.

If these people are getting liver damage and using AS PRESCRIBED or as the OTC label says to use it, that's when they'll pull it and discontinue.

As already stated, deducting how it was taken could prove difficult.

This seems to happen with every diet pill eventually. Each time a new one comes out I assume it's just a matter of time before these things get reported.