FDA Announces It Will Significantly Restrict Access to the Diabetes Drug Avandia
September 23, 2010
Today, the Food and Drug Administration (FDA) announced that it will significantly restrict the use of the diabetes drug Avandia and other drugs containing rosiglitazone to patients with Type 2 diabetes who cannot control their diabetes on other medications. These new restrictions are in response to data that suggest an elevated risk of cardiovascular events, such as heart attack and stroke, in patients treated with Avandia.
The FDA, in its announcement, noted that it will require GlaxoSmithKline (GSK) to develop a restricted access program for Avandia under a risk evaluation and mitigation strategy (REMS). Under the REMS, Avandia will be available to new patients only if they are unable to achieve glucose control on other medications and are unable to take Actos (pioglitazone), the only other drug in this class. Current users of Avandia who are benefiting from the drug will be able to continue using the medication if they choose to do so. Doctors will have to attest to and document their patients' eligibility; patients will have to review statements describing the cardiovascular safety concerns associated with this drug and acknowledge they understand the risks. The agency anticipates that the REMS will limit use of Avandia significantly.
The European Medicines Agency (EMA) has suspended the marketing authorization for all rosiglitazone-containing medicines (Avandia, Avandamet® and Avaglim®). These medicines will no longer be available in Europe within the next few months.
The American Diabetes Association, The Endocrine Society and the American Association of Clinical Endocrinologists urge patients who are currently taking Avandia or any combination pill that includes Avandia to contact their diabetes care provider’s office for instructions about treatment options. Patients should be aware that stopping a diabetes medication without consulting a doctor can result in higher levels of blood glucose that may cause serious short term health problems and could increase the risk of long term diabetes-related complications.
Patients and health care professionals should also be aware that multiple classes of drugs, often with more than one agent per class, are available to achieve and maintain glucose control in type 2 diabetes. In order to limit the risk of long-term complications, optimal glucose control, along with control of other risk factors, such as high blood pressure and cholesterol, is critically important for patients with type 2 diabetes. A number of other medications can be used to control diabetes and should be discussed with a patient’s health care team. For more information on the different classes of available medications drugs: http://www.diabetes.org/living-with-diabetes/treatment-and-care/medication/oral-medications/what-are-my-options.html.
The American Diabetes Association, The Endocrine Society, and American Association of Clinical Endocrinologists continue to support the FDA in its role as the regulatory agency that makes decisions regarding drug safety and efficacy.
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.
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.
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 www.aace.com, become a fan on Facebook at www.facebook.com/theaace or follow us on Twitter at www.twitter.com/theaace.