FDA probes safety of weight-loss med

FDA drug-safety types are training their magnifying glass on orlistat, the weight-loss drug sold in prescription and over-the-counter forms. The agency has received at least 32 reports of liver problems in patients using either the prescription version Xenical (marketed by Roche) or the OTC strength Alli, sold by GlaxoSmithKline. Twenty-seven of those patients were hospitalized and six of them suffered liver failure.

"The issues here are complex," said Dr. Steven Osborne, executive director of the FDA's safety board, in a statement. The "early communication" from the agency stressed that "no definite association between liver injury and orlistat has been established" and that consumers should continue using the meds as directed unless they experience symptoms of liver injury.

Both Glaxo and Roche defended the weight-loss remedy. Glaxo said that people who are overweight or obese tend to be predisposed to liver disorders and pointed out that orlistat works in the gastrointestinal tract, with "no obvious biological mechanism that would suggest liver damage can occur." Roche said it had "continually monitored and analyzed the hepatic safety of Xenical," finding "no evidence of a link between Xenical and liver injury."

- see the FDA communication
- check out the article in the Los Angeles Times
- read the Reuters story

Suggested Articles

Mylan and Pfizer's Upjohn have a name for their pending merger: Viatris. Heard that before? So has Mylan, which owns a subsidiary with the same name.

Intercept presented a data analysis that found treatment with Ocaliva led to "early and consistent improvements" in a range of noninvasive tests.

Days before Amarin faces a pivotal FDA vote on its Vascepa expansion, advisors are set to scrutinize the placebo used in its pivotal outcomes trial.