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M. Regina Castro, M.D.
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Avandia and Actos safety concerns: What should I do?
I've heard the Food and Drug Administration has issued restrictions and cautions about diabetes drugs Avandia and Actos. If I take one of these drugs, what should I do?
from M. Regina Castro, M.D.
Avandia and Actos — which belong to a class of drugs known as thiazolidinediones — are two of many oral medications designed to control blood sugar in those with diabetes. These drugs lower the amount of sugar in your blood by making your tissues more sensitive to insulin, a hormone that regulates the absorption of sugar into your cells.
Risks associated with Avandia and Actos
Avandia and Actos have been linked to serious risks, including the Food and Drug Administration's (FDA's) primary concern — an increased risk of heart attack with Avandia, and of heart failure with Actos. Actos has also been linked to an increased risk of bladder cancer.
Because of these risks, the FDA has issued strong cautions about the use of both of these drugs and has implemented a restricted access program for Avandia.
FDA restrictions allow the use of Avandia only if:
- You're already taking Avandia and have determined with your doctor that the benefits of the medication outweigh the potential cardiovascular risks for you.
- You're unable to take or control your blood sugar with other medications and have determined with your doctor that the benefits of Avandia outweigh the potential cardiovascular risks for you.
In addition, the FDA requires your doctor to provide you a copy of the Avandia medication guide and review it with you. The FDA then requires that you and your doctor enroll in a program — the Avandia-Rosiglitazone Medicines Access Program — to be able to receive and prescribe this medication. Avandia is only available by mail from pharmacies enrolled in the program.
What's best for you?
If you take or are considering taking either of these drugs, talk with your doctor about what's best for you.
If Avandia or Actos is already part of your diabetes treatment plan, take the drug as prescribed. Although an increased risk of heart attack, heart failure or bladder cancer is nothing to take lightly, the risk isn't considered an emergency. Discuss your concerns with your doctor. It's much riskier to stop taking a diabetes medication on your own.Next question
Blood glucose monitors: What factors affect accuracy?
Castro RM (expert opinion). Mayo Clinic, Rochester, Minn. April 8, 2013.
- FDA drug safety communication: Update to ongoing safety review of Actos (pioglitazone) and increased risk of bladder cancer. Food and Drug Administration. http://www.fda.gov/Drugs/DrugSafety/ucm259150.htm. Accessed April 8, 2013.
- FDA drug safety communication: Reminder to healthcare providers and patients to enroll in the Avandia-Rosiglitazone Medicines Access Program. Food and Drug Administration. http://www.fda.gov/Drugs/DrugSafety/ucm277629.htm. Accessed April 8, 2013.
- Pioglitazone hydrochloride. Food and Drug Administration. http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm183120.htm. Accessed April 8, 2013.
- Cariou B, et al. Thiazolidinediones and PPARy agonists: Time for a reassessment. Trends in Endocrinology & Metabolism. 2012;23:205.
- Ferrara A, et al. Cohort study of pioglitazone and cancer incidence in patients with diabetes. Diabetes Care. 2011;34:923.
- What I need to know about diabetes medicines: Insert J. National Diabetes Information Clearinghouse. http://diabetes.niddk.nih.gov/dm/pubs/medicines_ez/insert_J.aspx. Accessed April 8, 2013.
- Medical societies respond to the FDA's safety announcement on the use of the diabetes medication Actos (pioglitazone). American Diabetes Association. http://www.diabetes.org/for-media/2011/medical-societies-respond-to-pioglitazone.html. Accessed April 8, 2013.