The U.S. Food and Drug Administration’s (FDA) Joint Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee has completed their evaluation of the scientific research available on the safety of rosiglitazone. The deliberations of the panel reflected the complexity of the issues, with several members voting to add additional warnings or to withdraw the drug from the U.S. market. Ultimately, the final recommendation was to allow Avandia to remain on the market. Now that the expert panel has concluded its meeting, the FDA will review their recommendations and make the final decision on whether the drug remains available to patients.
Even with the panel’s recommendation, the amount of scrutiny the drug has received may lead some diabetes patients who currently take rosiglitazone to want to stop taking the drug. The Endocrine Society, American Diabetes Association and the American Association of Clinical Endocrinologists urge patients to not make any changes to their medication use without discussing their treatment with their physician.
“Patients should continue taking all currently prescribed medications unless instructed otherwise by their health care provider,” said Dr. Robert A. Vigersky, immediate Past President of The Endocrine Society. “Stopping diabetes medications can cause significant harm and result in higher levels of blood glucose that may cause severe short term health problems and could increase the risk of diabetes-related complications in the long term.”
“The worst outcome would be to not treat diabetes properly, thereby risking its complications,” said Dr. Daniel Einhorn, President of the American Association of Clinical Endocrinologists. “This unintended consequence has happened with past inquiries into diabetes medications, and we very much want to avoid it happening again.”
Reports regarding the cardiovascular safety of rosiglitazone have not been definitive. While some analyses have suggested an increased cardiovascular risk with use of the diabetes drug others have not shown substantial evidence of such an association.
“Patients should be aware that regardless of the opinion and decisions on rosiglitazone, there are numerous drugs available to maintain glucose control in people with type 2 diabetes. Patients should discuss these options with their health care providers,” said Dr. Richard Bergenstal, President, Medicine and Science, American Diabetes Association.
Following any decision from the FDA, The Endocrine Society, The American Diabetes Association and the American Association of Clinical Endocrinologists will provide detailed information interpreting FDA action for both health care professionals and patients with diabetes.
On July 12th, The Endocrine Society, The American Diabetes Association and the American Association of Clinical Endocrinologists issued a joint statement to help patients and physicians make informed decisions regarding use of rosiglitazone. The statement can be found online at: http://www.endo-society.org/advocacy/policy/upload/Potential-CDV-Associated-with-Rosiglitazone.pdf.
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 100 countries. Society members represent all basic, applied, and clinical interests in endocrinology. The Endocrine Society is based in Chevy Chase, Maryland. To learn more about the Society and the field of endocrinology, visit our site at www.endo-society.org.
The American Diabetes Association is leading the fight to stop diabetes and its deadly consequences and fighting for those affected by diabetes. The Association funds research to prevent, cure and manage diabetes; delivers services to hundreds of communities; provides objective and credible information; and gives voice to those denied their rights because of diabetes. Founded in 1940, our mission is to prevent and cure diabetes and to improve the lives of all people affected by diabetes. For more information please call the American Diabetes Association at 1-800-DIABETES (1-800-342-2383) or visit www.diabetes.org. Information from both these sources is available in English and Spanish.
AACE is the world’s largest professional medical organization of clinical endocrinologists with more than 6,500 members in the United States and 91 other countries. AACE members are physicians who specialize in endocrinology, diabetes, and metabolism. For more information about AACE, visit our Web site at http://www.aace.com/, become a fan on Facebook at www.facebook.com/theaace or follow us on Twitter at www.twitter.com/theaace.
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AACE press release