Chevy Chase, MD — Responding to the Senate Finance Committee’s report to the FDA detailing concerns about the safety of the drug rosiglitazone (Avandia), The Endocrine Society released today a statement (http://www.endo-society.org/advocacy/policy/upload/avandia.pdf) urging the FDA to re-convene its Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) to examine the safety and efficacy of the drug.  Avandia is a drug approved by the FDA to treat type 2 diabetes.

The Senate Finance Committee’s recent report is the result of an inquiry into the drug that began after the release of a 2007 study published in the New England Journal of Medicine (NEJM) on the cardiovascular effects of rosiglitazone.  The study indicated a 43 percent higher risk of heart attack for those taking Avandia compared to people taking other diabetes drugs or no diabetes medication.

Following publication of the NEJM study, the FDA asked the maker of rosiglitazone to perform a cardiovascular safety trial called TIDE (Thiazolidinedione Intervention With Vitamin D Evaluation) to compare Avandia to other diabetes treatments.  TIDE, currently enrolling patients, is a six-year study involving 16,000 participants.

“Based on new information surrounding the cardiovascular health risks of rosiglitazone that has come to light since 2007, the Society recommends that the FDA re-convene the EMDAC prior to the completion of the TIDE Study,” said Robert A. Vigersky, president of The Endocrine Society.  “The FDA’s EMDAC process of open and objective deliberation between outside experts, FDA specialists and the general public is aimed at ensuring scientifically valid conclusions.”

While the FDA re-examines the safety of rosiglitazone and the appropriate criteria used to define such safety, the Society suggests that health care providers react in a measured way to the ongoing controversy.  In addition, the Society recommends that physicians discuss with each diabetic patient taking rosiglitazone both the safety issues that have been raised with the use of this drug and the risk/benefit of its continued use.

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Founded in 1916, The Endocrine Society is the world's oldest, largest, and most active organization devoted to research on hormones and the clinical practice of endocrinology. Today, The Endocrine Society's membership consists of over 14,000 scientists, physicians, educators, nurses and students in more than 80 countries. Together, these members represent all basic, applied, and clinical interests in endocrinology. The Endocrine Society is based in Chevy Chase, Md. To learn more about the Society, and the field of endocrinology, visit our web site at www.endo-society.org.