PCOS News Alert:  F.D.A. Reviewing Rezulin Deaths
by Ellen Friedman Bender

The New York Times reported on February 23, 2000 that the Food and Drug Administration is investigating the recent increase in deaths caused by the diabetes medication Rezulin. According to the article, Rezulin is reported to have caused 58 deaths and 10 liver transplants since it was approved by the FDA in 1997.    The article quoted a Los Angeles Times story which reported that the F.D.A. official "most closely involved with the government's rapid approval of the drug " informed his superiors at the F.D.A. "that he saw no reason the agency should delay removing the drug from the market."

Disturbingly, the article reported that an F.D.A. investigation "found that only 2.7% of patients taking Rezulin for three months were being monitored in the close way the agency had recommended, " despite repeated warnings given to doctors.

Rezulin, which is marketed by Parke-Davis and is also known as troglitazone, is one of the insulin sensitizing medications that has been creating a buzz in the PCOS community (despite the fact that the drug has never been approved by the F.D.A. for use in non-diabetic PCOS patients). Research has found that insulin sensitizing medications such as rezulin may be effective in restoring ovulation and diminishing some of the other symptoms associated with PCOS. Other insulin sensitizing medications which have been F.D.A. approved for diabetics but not non-diabetic women with PCOS include Metformin (Glucophage), Pioglitazone (ACTOS), Rosiglitazone (Avandia). None of these medications were mentioned in the New York Times article.

If you are currently taking Rezulin or considering taking it, you should discuss the risks with your physician and make sure that you are being adequately monitored. To read the full text of the article, go to www.nytimes.com

Ellen Friedman Bender is a member of the board of directors of the American Infertility Association. She co-chaired AIA's 1999 symposium on PCOS. She has appeared on national and local media to discuss PCOS.