FDA probes liver damage with weight loss pill alli

Aug 24, 2009 By MATTHEW PERRONE , AP Business Writer

(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 , though Xenical is manufactured by Swiss firm Roche.

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

"Consumers should consult their health care professional if they are experiencing symptoms," the agency said on its Web site. Signs of 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. Glaxo representatives did not immediately return calls for comment Monday afternoon.

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 Vioxx.

Shares of London-based Glaxo fell 57 cents to $39.46 in afternoon trading.

©2009 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.

Explore further: Britain to offer all infants meningitis B vaccine

Related Stories

Questions and answers about pain medicine dangers

Jul 07, 2009

(AP) -- A Food and Drug Administration panel has recommended limits on Tylenol and other drugs containing acetaminophen because of risks for liver failure. Maximum recommended doses for over-the-counter Tylenol would be ...

FDA: Dieters should stop Hydroxycut use now

May 01, 2009

(AP) -- Government health officials warned dieters and body builders Friday to immediately stop using Hydroxycut, a widely sold supplement linked to cases of serious liver damage and at least one death.

Fatty liver disease medication may have no effect

Jan 13, 2009

A new randomized, prospective trial has shown that orlistat, a commonly prescribed inhibitor of fat absorption, does not help patients with fatty liver disease (FLD) lose weight, nor does it improve their liver enzymes or ...

FDA requires Chantix, Zyban to have warning

Jul 01, 2009

(AP) -- The Food and Drug Administration will require two smoking-cessation drugs, Chantix and Zyban, to carry the agency's strongest safety warning over side effects including depression and suicidal thoughts.

FDA group recommends acetaminophen liver warnings

May 27, 2009

(AP) -- A Food and Drug Administration report released Wednesday recommends stronger warnings and dose limits on drugs containing the painkiller acetaminophen, citing an increased risk of liver injury.

Recommended for you

US aims to cut antibiotic use

Mar 27, 2015

US President Barack Obama on Friday rolled out plans to cut inappropriate antibiotic use by half, in an effort to tackle drug resistance.

Questions over value of new antibiotics to tackle resistance

Mar 26, 2015

In the first installment of a new series, Peter Doshi, Assistant Professor at the University of Maryland School of Pharmacy and Associate Editor at The BMJ, asks why authorities are approving drugs with little evidence they d ...

User comments : 0

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.