Aaron Lohr
Manager, Media Relations
Phone: (240) 482-1380
Email: alohr@endo-society.org

July 31, 2007

Chevy Chase, MD—The Endocrine Society supports the nearly unanimous decision of the U.S. Food and Drug Administration’s (FDA) advisory committee to keep the diabetes drug Avandia (rosiglitazone) on the market and available to patients while including a warning on the drug's label regarding its possible link to heart disease.

The FDA’s decision on Avandia is consistent with a statement issued by The Endocrine Society on May 21, 2007, in response to concerns raised about this drug in a meta-analysis published in the New England Journal of Medicine (NEJM).

In its written testimony to the FDA, the Society expressed its belief that no precipitous action should be taken by the FDA based solely on the NEJM study. The Society also urged the FDA to use the most rigorous scientific data in its evaluation of rosiglitazone.

The Society continues to advise healthcare providers to counsel their patients about the drug, discuss its implications on an individual basis, and review the risks and benefits of remaining on rosiglitazone versus changing therapy.

It its May 21 statement, the Society also acknowledged that: “It would also seem prudent, given the very high baseline risk of cardiovascular events in patients with diabetes, to redouble efforts to reduce other cardiovascular risk factors… in those diabetic patients taking medications with postulated cardiovascular side effects.”

The full text of the Society’s statement can be found here: http://www.endo-society.org/publicpolicy/policy/avandia.cfm

 

 

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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.