FDA staff questions Meridia safety

As the advisory panel showdown over Abbott Labs' weight loss drug Meridia nears, FDA scientists have released their assessment of the safety data. Their conclusion? They are worried about the deaths of Meridia patients--especially those who don't have the cardiovascular risks that, according to the drug's label, contraindicate its use.

The scientists last fall reviewed 17 reported deaths, finding that they "cannot be dismissed as coincidental and unrelated to" the patients' Meridia use. Another review of death reports noted that "young people without known risk factors (aside from obesity) have died" soon after starting Meridia therapy, NPR reports.

Abbott maintains that the risks of Meridia are outweighed by its benefits and that new data on its cardiovascular safety doesn't change the fact that it's safe for patients when used strictly according to its label. But in a memo for review at Wednesday's meeting, the company also said that the label might need upgrading with a boxed warning.

The FDA is asking the advisory panel to weigh in on ways Meridia's use might be made safer--and to determine whether the drug should stay on the market at all. European regulators have already pulled it. We'll see what the FDA's experts decide. In any event, Meridia has already lost ground on the sales front, so it's not as big a drug for Abbott as it once was. Analysts expect $101 million in global sales this year, compared with $340 million in 2008.

- see the NPR blog post
- get more from the Wall Street Journal
- read the Reuters news
- check out the Bloomberg coverage