After approving Alli (orlistat) the only weight-loss drug more than two years ago, the FDA has been forced to backtrack on its safety, amid reports the over-the-counter drug may be connected to liver damage.
The news isn't a complete surprise, considering the prescription counterpart to Alli -- Xenical -- includes liver problems among its potential side effects. And it comes a month after Canadian-based Iovate Health Sciences pulled 14 of its Hydroxycut weight-loss products based on 23 cases of serious liver damage and one death associated with their use.
This is the second time orlistat was included in a list of drugs associated with safety risks compiled by the FDA this year. The agency took no action on reports that Xenical may have been linked to rectal bleeding.
Alli and Xenical are only two out of more than 900 drugs connected with liver problems, among the most typical reasons a drug is withdrawn from the market.
Nutra Ingedients-USA.com June 5, 2009
AboutLawsuits.com May 27, 2009
Alli is a trademark of SmithKline Beecham Corporation.