Call for Ban on Xenical and Alli

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Group Calls on FDA to Pull Alli, Xenical

Weight Loss Drugs Linked to Liver, Kidney, and Pancreas Damage

By Mann

WebMD Health News

Reviewed by J. , MD

April 15, 2011 -- The consumer advocacy group Public Citizen is urging the FDA

to immediately pull two weight loss drugs, Xenical and Alli, from the market.

The group says the drugs' risk for liver, pancreas, and kidney damage greatly

outweighs any potential weight loss benefits.

Xenical and Alli are different strengths of the drug orlistat.

Prescription-strength Xenical is manufactured by Roche. Alli is available over

the counter, and is one-half the strength of Xenical. These drugs block the

absorption of fat in the gastrointestinal tract. Alli manufacturer

GlaxoKline announced plans to sell the rights to the over-the-counter drug

Alli.

In May 2010, the FDA issued a warning based on post-marketing adverse events

about risk of severe liver injury in people taking orlistat, citing 12 foreign

reports of liver toxicity with Xenical and one case of liver toxicity in the

U.S. associated with the use of Alli. Two of these patients died, and three

needed liver transplants as a result of this damage.

Washington-D.C. based Public Citizen has now identified 73 cases of kidney

stones linked to use of these drugs, 23 of which required hospitalization, along

with 47 cases of acute pancreatitis from the FDA adverse event reports. This is

Public Citizen's second petition to have Xenical removed from the market. Their

first petition was rejected. The FDA will now mull the new petition.

If you are taking these drugs, don't wait for the FDA to act, says Public

Citizen director Sidney Wolfe, MD.

" Stop taking them, " he says. " Unlike other drugs, which have a withdrawal

syndrome that you would go through if you suddenly stop, there is no downside to

stopping Xenical or Alli.

" The risks greatly outweigh the benefits, " he says. " The drug doesn't add all

that much to weight loss efforts. This has got to be the end of the drug. How

much more danger do you need for a drug that doesn't work very well? "

According to Public Citizen, the average additional weight loss after one year

among people taking orlistat while dieting and exercising compared to those who

just did diet and exercise was 5.6 additional pounds with the 60 mg dose and 7

additional pounds with the 120 mg dose. The drugs are also known to cause other

mild side effects, including inability to control bowel movements, oily or fatty

stools, and oily spotting.