OTC Weight-Loss Drug Alli May Put Users at Risk for Liver Damage | Shapiro, Washburn & Sharp

The U.S. Food and Drug Administration announced Monday that it “is reviewing adverse event reports of liver injury in patients taking the weight loss drug orlistat, marketed as the prescription drug Xenical and the over-the-counter medication Alli.”

Thus, the poor safety record of weight-loss drugs seems unblemished. Or, more accurately, as filled with blemishes as ever.

In the late 1990s, the FDA ordered all versions of the then-popular diet pill phen-fen–a combination of the prescription medications phentermine and fenfluramine–off the market because users experienced usually rare heart and lung disorders. And while phentermine continues to be available, its severe side effects limit its use.

The dietary supplement for weight loss Hydroxycut was subject to an FDA warning and recall this past May because of liver damage among users. According to the agency, 32 orlistat users have experienced “serious liver injury.”

I give FDA credit for alerting consumers to newly identified potential dangers from using Alli or Xenical. At the same time, my colleagues and I have often found it necessary to comment on the agency’s slow or absent response to drug and dietary supplement safety issues.

If FDA finds it necessary to request stronger warnings on prescription or OTC versions of orlistat, any liability for injuries to patients would rest primarily with the drug’s makers, Roche and GlaxoSmithKline. Neither company is a stranger to patient lawsuits. Roche, facing numerous civil claims concerning harm from its antiacne drug Accutane, recently withdrew the product for the U.S. market. GSK currently faces civil suits over its diabetes drug Avandia.

About the Editors: Shapiro & Appleton& Duffan personal injury law firm is based in Virginia (VA), near the Northeast North Carolina (NC) border. Lawyers with the firm practice primarily in the southeastern U.S. and handle injury law cases, including car, truck and railroad accidents, medical negligence cases, and more. The firm’s website is hsinjurylaw.com. Lawyers with Shapiro & Appleton& Duffan also edit the injury law blogs Virginia Beach Injuryboard, Norfolk Injuryboard, and Northeast North Carolina Injuryboard and have compiled a video library covering many FAQs on personal injury subjects. The firm’s lawyers are licensed in VA, NC, SC, WV, DC and KY.