Science

FDA Knew About Avandia Risks in 2002

According to a memo uncovered by activist group Public Citizen, the FDA knew five years ago about the dangers of Avandia, the diabetes drug recently linked to high risks of heart failure. Another drug, Takeda Pharmaceuticals’ Actos, was also mentioned in the memo. The 2002 FDA memo analyzed 25 cases of heart failure in Avandia […]

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According to a memo uncovered by activist group Public Citizen, the FDA knew five years ago about the dangers of Avandia, the diabetes drug recently linked to high risks of heart failure. Another drug, Takeda Pharmaceuticals' Actos, was also mentioned in the memo.

The 2002 FDA memo analyzed 25 cases of heart failure in Avandia patients and an additional 22 cases in patients who were taking Actos. In 26 of the cases, the patients had not previously been diagnosed with heart failure — a signal the safety reviewers found worrisome. One patient taking Avandia died.

In the memo, the safety reviewers said the symptoms of fluid retention appeared to build up slowly over a period of several months in an "insidious" manner that might not be easy for doctors to detect. And they expressed concern that such risks were not "clearly defined" in the prescribing literature available to doctors.

Concerns about diabetes drug Avandia aren't new [Los Angeles Times]