Wednesday, June 4, 2008
Today's Wall Street Journal reports that Acompli has been linked to several deaths in the United Kingdom. The U.S. FDA rejected Acompli for sale in the United States last year. Here's an excerpt from the Journal's report:
A spokesman for Paris-based Sanofi-Aventis said two of the deaths were the result of heart attacks, a risk that is linked to obesity. One patient died of infectious disease, and the fifth died from "sudden death," he said. The deaths occurred mostly before 2008, he said. He declined to comment further.
With such "real-world" reports, it is often unclear if the drug was the culprit. It isn't clear what actions regulators will take, if any. All approved drugs must have surveillance programs after they go on sale to record adverse reactions or deaths in patients taking them. The document, posted Tuesday on the agency's Web site, is a routine report.
That said, this report may draw more scrutiny, given Acomplia's difficulty getting approval in other countries.
With so many people suffering from obesity around the world, drug companies have been eager to find drugs to treat the disease. Before regulators' concerns, Acomplia and a drug from Merck & Co. had initially seemed promising, offering a new kind of obesity treatment that blocks certain brain receptors that regulate appetite.