martes, 9 de junio de 2009

ROCHE: Las cosas se le ponen "gordas" a Alli y Xenical con la FDA...

WASHINGTON -(Dow Jones)- The Food and Drug Administration is conducting a safety review of weight-loss drugs Alli and Xenical and looking at whether the drugs are linked to liver problems.

The FDA, in a quarterly report of drugs that lists potential safety issues the agency is evaluating, also said it was looking at serious skin problems possibly involving the smoking cessation drug Chantix and the over-active bladder drug Detrol. Both drugs are made by Pfizer Inc. (PFE). The most recent quarterly report was posted to the FDA's Web site Thursday.

Alli is an over-the-counter weight loss drug by GlaxoSmithKline PLC (GSK) and Xenical is the prescription strength version of the same drug made by Roche.

Con respecto a alli:

Alli, approved in 2007, is currently the only FDA-approved over-the-counter weight loss product.

Malesia Dunn, a spokeswoman for GlaxoSmithKline's consumer health division, said there's no evidence Alli causes liver problems. She said the company has received a "few" reports of mild liver side-effects in relation to Alli, but noted that such reports don't mean a product has caused a particular problem. Dunn said about six million people use Alli daily.

Con respecto a XENICAL:

Terence Hurley, a Roche spokesman, also said there's no evidence of a link between Xenical and liver injury and noted obesity is also a high risk factor for hepatic injury. However, he said the company "takes issues of patient safety very seriously and will continue to be in contact with the FDA on this."


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