Consumer group urges withdrawal of Xenical

By Hubert Vigilla

Published on April 11, 2006

Public Citizen's request was based on research from a December 2005 pharmacological study published in the journal Cancer Letters. The study showed "a significant increase" of precancerous lesions in the large intestine of lab animals that were given Xenical.

The consumer group also found that there have been at least 28 cases of breast cancer among Xenical users since the drug entered the market in 1999.

Roche, the company that distributes and markets orlistat under the brand name Xenical, has yet to comment on the petition.

Public Citizen has also petitioned the FDA to prohibit over-the-counter sales of Xenical. The FDA recently granted GlaxoSmithKline conditional approval for over-the-counter sales of Xenical.

Xenical is a fat-blocking drug taken with meals three times a day. It is designed to prevent the body from absorbing fat, but has been known to cause excess gas and other types of gastronomical problems.

According to the Xenical label, lab rats and lab mice showed no evidence of cancer even when given doses that would be dozens of times greater than the equivalent recommended human dose.

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