Avandia

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Initial accreditation July 2005

Updated Sept 2011

Questions about Avandia - What Does the FDA Alert Mean to Me?

With Update Jan 2008

Written by:

Hector Fontanet, M.D., FACC

Joan Stelzner, ARNP

The New England Journal of Medicine (NEJM) recently published an article that suggests that the

use of Rosiglitazone maleate (Avandia, Avandamet and Avandaryl) used to treat Diabetes Type II may be

associated with increased heart attack or angina. In conjunction with this article, on May 21, 2007, the

Food and Drug Administration (FDA) issued an alert about a potential safety issue related to the use of

Avandia. As with all medical warnings and advice provided to the public via television and radio, the information

should be considered carefully. One should always seek medical advice from a licensed healthcare provider

and not rely solely on information gathered from secondary sources.

The President of the American College of Cardiology, James Dove, has stated that it is important to put

this recent information into perspective as additional data from other clinical trials may contradict the information

published in the NEJM. In fact, the FDA has also stated that other studies show contradictory evidence

and that it is not known whether other approved medications in the same class or other drugs for Type II Diabetes

have less, the same, or more associated risks. Specific information about the Clinical Trials is attached

to this article for further analysis. These trials vary in clinical design and included different population groups

including those with underlying coronary disease and those without underlying coronary disease, and length

of patient follow-up. Though some of the data showed additional risk of cardiovascular events,

some showed no increased risk at all. Again, the FDA has not confirmed the clinical significance of the reported risks.

It is imperative that you speak with your healthcare provider and that you have all the necessary information to make

appropriate therapeutic decisions. At this time we do not recommend discontinuation of Avandia.

Loss of glucose control will be more harmful to you.

Sources:

UPDATE January 2008

Avandia can cause or worsen heart failure. If you have severe heart failure (very poor pumping ability of the heart), you cannot be started on Avandia. Avandia is also not recommended if you have heart failure with symptoms (such as shortness of breath or swelling) even if these symptoms are not severe.
Avandia may increase your risk of other heart problems that occur when there is reduced blood flow to the heart, such as chest pain (angina) or heart attack (myocardial infarction). This risk appeared higher in patients taking medicines called nitrates or insulin.
Do NOT Avandia with insulin or with nitrates.

Source: