Consumer advocacy group Public Citizen has petitioned the FDA to immediately remove the prescription version of Xenical from the market due to unacceptable safety risks. Xenical (orlistat), an obesity medication made by Roche Pharmaceuticals, significantly increases the risk of a precursor to colon cancer, called aberrant crypt foci (ACF).
Recently the FDA sent an approvable letter to GlaxoSmithKline regarding sales of an over-the-counter version of orlistat. If GlaxoSmithKline meets the FDAs conditions, which have NOT been made public, this drug would enter the final approval phase for over-the-counter distribution.
Evaluation of Roches pharmacological findings and independent clinical research indicates that orlistat causes ACF in animals. According to Public Citizen, a large body of scientific research indicates that ACF is a common precursor to colon cancer. In 1997, the FDAs own review of orlistat showed concern with colonic cell proliferation. This drug was not approved at that phase because literature indicated a four- to seven- fold increase in the risk of developing breast cancer while taking orlistat.
In addition to the risk of cancer, orlistat has been shown to increase the risk of serious gastrointestinal complications and the depletion of important vitamins and minerals from the body. The efficacy of orlistat is also been questioned, as research shows less than a three percent difference in weight loss in patients taking orlistat for four years compared to those taking a sugar pill.
The director of Public Citizens Health Watch Group, Dr. Sidney Wolfe, says, The failure to ban the prescription version of this drug or, worse, to make it much more widely available by allowing OTC sales, is a decision that is likely to increase the cancer risk.
Allowing such a dangerous drug to remain on the market for long-term treatment of a non-fatal condition is absolutely unacceptable, according to the group. Public Citizen has an exceptional record when it comes to exposing the dangers of prescription medications while urging regulators to recall or add warnings to these defective drugs. The group has issued warnings over Vioxx, Bextra, Baycol, and others years before these drugs were recalled due to unacceptable side effect risks.
Orlistat is known to increase the risk of cancer and should not be approved as a prescription or over-the-counter medication.
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