The FDA announced yesterday that new warning labels about liver injury will be placed on two market leading weight loss drugs, prescription strength Xenical and the-over-the counter Alli. The decision was based on just 13 reports of liver injury over the pas decade 12 reports of liver damage associated with Xenical outside the U.S., and a single case in the U.S. from Alli. An estimated 40 million people worldwide have taken either Xenical or Alli, manufactured by Roche and GlaxoSmithKline.
The FDA does note that, At this time, a cause-and-effect relationship of severe liver injury with [Xenical or Alli] use has not been established. This over-reaction again highlights the FDA s emphasis of risks over benefits, an ideology that dominates the FDA, says ACSH s Dr. Gilbert Ross. Why would anyone at the agency slap a warning on effective drugs for so infrequent adverse events not even definitely linked to those drugs?
ACSH's Dr. Elizabeth Whelan emphasizes it s important to keep these drugs available. Alli is the only over-the-counter weight loss drug on the market that has proven results by effectively blocking absorption of fat ingested by up to 25 percent, she says, adding that it s likely the warning label will deter people from continuing with their weight loss program, which would be completely counterproductive to countering the effects of obesity.
