FDA Probes Weight Loss Drug Liver Damage

Fda Warning Dozens Hospitalized from Over-the-Counter Drug Alli Prescription Counterpart Xenical..

by CBS/AP

Published: Tue, August 25, 2009 - 10:07 am CST Last Updated: Tue, August 25, 2009 - 10:09 am CST

(CBS/ AP) The Food and Drug Administration is investigating reports of liver damage in patients taking "alli," the only nonprescription weight loss drug approved by the agency.

Regulators said Monday they have received more than 30 reports of liver damage in patients taking alli and Xenical, the prescription version of the drug. The reports, submitted between 1999 and October 2008, included 27 hospitalized patients, and six who suffered liver failure.

Alli and Xenical are both marketed by British drugmaker GlaxoSmithKline PLC, though Xenical is manufactured by Swiss firm Roche.

The FDA says it has not established a direct relationship between the weight loss treatments and liver injury, and advised patients to continue using the drugs as directed.

Appearing on The Early Show Tuesday, Dr. Holly Phillips said, "Most people shouldn't take this drug. This is only for people who are obese, meaning they have a body mass index over 30. And even though it's over the counter - you should only take it under the advice of your doctor. …It's not to lose five pounds to squeeze into your jeans - it's really for people who are obese."

"Consumers should consult their health care professional if they are experiencing symptoms," the agency said on its Web site. Signs of liver damage include fatigue, fever, nausea and vomiting.

The FDA said it's reviewing additional details about the suspected cases of liver injury submitted by manufacturers.

Roche referred questions to GlaxoSmithKline.

A spokeswoman for GlaxoSmithKline said there is no evidence the company's drug causes liver injury, noting that it primarily acts on the intestinal tract. She said alli's safety has been studied in more 30,000 patients enrolled in 100 clinical studies.

"Liver changes can have many causes," said Debbie Bolding, in a statement. "People who are overweight and obese are predisposed to liver-related disorders."

The FDA first approved Xenical in 1999 and alli in 2007. The prescription pill is twice as potent as alli, which can be bought over the counter. Glaxo reported $123 million in sales for alli last year, while Roche posted $472 million in revenue for Xenical.

In general, the FDA has started notifying the public earlier about possible safety issues with drugs, after coming under fire for acting too slowly on problems with blockbuster treatments like Merck's painkiller Vioxx.

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