Obesity Drug, Orlistat (Xenical®), May Have Harmful Side Effects
WASHINGTON, DC — June 30, 2006 — The obesity drug orlistat is dangerous and should be banned, according to a petition to the Food and Drug Administration filed by the consumer group, Public Citizen, over two months ago. Despite the group’s petition, a panel advising the FDA has now approved an over–the–counter version of orlistat. The FDA must give its final approval before GlaxoSmithKline can sell its nonprescription version of the drug. Roche continues to market Xenical®, the prescription version of orlistat.
Orlistat use may lead to the formation of abnormal or “aberrant crypt foci.” Crypts are folds found in the lining of the intestine that lead into the tissue of the gastrointestinal tract. Aberrant crypt foci are either single crypts or groups of crypts that have errors such as increased size, thick linings, or unusual openings (Aberrant Crypt Focus). Many medical experts say that aberrant crypt foci are precancerous and biomarkers for colon cancer. Others believe that the association between aberrant crypt foci and cancer is not yet fully proven, however.
The Public Citizen petition cites a Brazilian study that shows that orlistat caused aberrant crypt foci in rats (Cancer Letter, 2005 Dec 22) and an extensive review of medical literature that suggests that aberrant crypt foci are precursors to colon cancer in humans (Biochim Biophys Acta., 2005 Nov 25; 1756(2): 83–96). The group also points to Roche’s own animal studies involving orlistat.
The FDA became aware of Roche’s animal studies linking orlistat to aberrant crypt foci in 1997, according to an article in the Cancer Letter (Vol. 32, No. 21, June 2, 2006). However, the agency failed to share this information with its advisory panel that met in January of this year to consider over–the–counter orlistat sales. Four researchers have now protested the withholding of this information, including one member of the panel, Neal Benowitz, a professor of medicine and biopharmaceutical sciences at the University of California, San Francisco. “This was not in any of the documents that we reviewed,” he commented about the aberrant crypt foci issue. “Unless it gets reported by the manufacturer or FDA, or unless someone brings it up who gives testimony, we may not know about this.”
Other Orlistat (Xenical®) Side Effects
Orlistat is not that much more effective than other drugs used for weight reduction, the Public Citizen petition said. In addition, the group analyzed the FDA database and found 28 cases of breast cancer among orlistat users. Another problem is that patients using orlistat excrete fat–soluble vitamins along with fat. This loss results in lowered levels of vitamins D, E, K, and beta–carotene.
“The FDA should not allow a drug ... to remain on the market for the long–term treatment of a non–lethal condition when it combines so little efficacy coupled with a still unresolved potential to cause breast and colon cancer,” the Public Citizen petition concluded. “[The] FDA is now considering increasing the number of people exposed to the drug by allowing OTC [over–the–counter] use. There is no scientific justification for this decision.”
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