Tuesday, May 22, 2007

Avandia flagged by FDA as a possible heart risk five years ago

Warning apparently buried

From the LA Times via Star-Tribune:

Diabetes drug Avandia caused concern 5 years ago

FDA reviewers flagged it in 2002 as possibly causing heart failure, yet a safety alert went out for it Monday.

By Ricardo Alonso-Zaldivar, Los Angeles Times

Last update: May 22, 2007 – 9:27 PM

WASHINGTON - Federal investigators warned nearly five years ago that the diabetes drug Avandia might be causing heart failure, according to an internal government memo released Tuesday by a consumer group.

Separately, in fast-moving developments in the latest drug safety investigation, a senior Republican senator said he learned that the Food and Drug Administration's safety office recommended the strongest possible warning for Avandia -- only to be overruled.

"The FDA didn't take that advice," said Sen. Charles Grassley, R-Iowa, a critic of the agency. "Instead, the warning about congestive heart failure risks with this drug is currently buried."

FDA spokeswoman Julie Zawisza said debate and disagreement are not unusual within the agency, "particularly when the science is unclear, complex or emerging."We do not have sufficient understanding of the data at this time to make a regulatory decision," she said.

The FDA issued a safety alert about Avandia on Monday after a study in the New England Journal of Medicine linked the drug to increased risk of heart attacks and death from cardiac disease. The alert underscored less prominent warnings of heart risks in prescribing literature primarily intended to inform doctors.

But a memo from FDA drug safety reviewers -- dated July 16, 2002 -- indicates there were significant concerns much earlier within the agency about Avandia and Actos.

Released by the watchdog group Public Citizen, the memo analyzed 47 early reports to the FDA of patients who went into heart failure and had to be hospitalized while taking one of the drugs. Congestive heart failure, or CHF, is a life-threatening condition that comes about when the heart can't pump enough blood to the rest of the body.

"This case series strongly supports the hypothesis that [these drugs], as a class, may be associated with CHF in diabetics," the memo said.