
- With Mayo Clinic endocrinologist
Maria Collazo-Clavell, M.D.
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Maria Collazo-Clavell, M.D.
Maria Collazo-Clavell, M.D.
Dr. Maria Collazo-Clavell is board certified in internal medicine, endocrinology, diabetes and metabolism. She's a consultant in the Division of Endocrinology, Diabetes, Metabolism & Nutrition at Mayo Clinic and an associate professor at College of Medicine, Mayo Clinic.
The Aibonito, Puerto Rico, native has been with Mayo Clinic since 1994.
She's a member of the American Association of Clinical Endocrinologists, the American College of Endocrinology, the American Diabetes Association and The Endocrine Society.
Dr. Collazo-Clavell is medical editor of diabetes content on Mayo's health information website and for "Mayo Clinic The Essential Diabetes Book." Her clinical interests include management of type 1 and type 2 diabetes, obesity and nutritional disorders.
Risk factors (1)
- Diabetes: Does alcohol and tobacco use increase my risk?
Symptoms (1)
- The dawn phenomenon: What can you do?
Complications (1)
- Diabetes: How do I help protect my liver?
Treatments and drugs (5)
- Diabetes management: Does aspirin therapy prevent heart problems?
- Blood glucose monitors: What factors affect accuracy?
- Avandia safety concerns: What should I do?
- see all in Treatments and drugs
Lifestyle and home remedies (11)
- Vegetarian diet: Can it help me control my diabetes?
- Diabetes: Are electric blankets off-limits?
- Caffeine: Does it affect blood sugar?
- see all in Lifestyle and home remedies
Alternative medicine (1)
- Diabetes treatment: Can cinnamon lower blood sugar?
Question
Avandia safety concerns: What should I do?
I've heard the news that the Food and Drug Administration has restricted the use of Avandia. I currently take this drug — what do I do?
Answer
from Maria Collazo-Clavell, M.D.
If you're currently taking or considering the drug, Avandia, the news regarding the Food and Drug Administration's (FDA's) increased restrictions on Avandia should prompt you to talk with your doctor about what's best for you as soon as possible. Avandia will no longer be available in retail pharmacies as of November 2011.
Avandia — which belongs to a class of drugs known as thiazolidinediones — is one of many oral medications designed to control blood sugar in those with diabetes. Avandia lowers 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.
Avandia has been linked to serious risks, including the FDA's primary concern — an increased risk of heart attack.
Initial FDA restrictions still allow the use of Avandia 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.
The FDA requires your doctor to provide you a copy of the Avandia medication guide and review it with you. The FDA also 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. After November 18, 2011, you'll no longer be able to obtain Avandia at retail pharmacies. It will only be available to you by mail, from pharmacies enrolled in the program.
If Avandia is part of your diabetes treatment plan, continue taking the drug as prescribed until you have the opportunity to talk to your doctor. Although an increased risk of heart attack is nothing to take lightly, the risk isn't considered an emergency. It's much riskier to stop taking a diabetes medication on your own.
Next questionAfter a flood, are food and medicine safe to use?
- Collazo-Clavell ML (expert opinion). Mayo Clinic, Rochester, Minn. Sept. 24, 2010.
- Avandia (rosiglitazone): REMS — Risk of cardiovascular events. Food and Drug Administration. http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm226994. Accessed Sept. 27, 2010.
- FDA drug safety communication: Updated risk evaluation and mitigation strategy (REMS) to restrict access to Rosiglitazone-containing medicines including Avandia, Avandamet, and Avandaryl. Food and Drug Administration. http://www.fda.gov/Drugs/DrugSafety/ucm255005.htm. Accessed May 18, 2011.

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