Monday, July 30, 2007

The rise (and possible fall) of the glitazones - so far

January 1997: The FDA approves Rezulin to treat type 2 diabetes the first glitazone drug, a class of drugs that help the body use insulin more effectively.

May 1999: The FDA OKs Avandia, the second glitazone.

July 1999: The FDA approves Actos, the third glitazone.

March 2000: The FDA asks Rezulin's maker to withdraw the drug because it is more toxic to the liver than Avandia or Actos.

April 2002: Avandia and Actos labels get new warnings about an increased risk of heart failure.
December 2005: Avandia maker GlaxoSmithKline and the FDA notify doctors of reports of new or worsening diabetic macular edema, fluid retention in the eye that can cause vision impairment, in patients taking the drug.

February 2007: Glaxo sends out a "Dear Health Care Professional" letter saying a clinical trial found a "significantly" higher risk of fracture in women who received Avandia compared with those who received metformin or glyburide, two older diabetes medications.

March 2007: Actos maker Takeda sends out a "Dear Health Care Professional" letter saying a review of its clinical trials database found an increased risk of fracture in women who received the drug.

May 2007: A New England Journal of Medicine study suggests Avandia raises risk of heart attacks. The FDA issues an Avandia "safety alert."

Source: USA Today

No comments: