AVANDIA
® WARNINGS STEPPED UP!
Two Wake Forest University doctors and professors have stepped to the forefront in expressing a heightened concern for the dangers of Avandia and similarly classed medications used to control type-2 diabetes. They warned against a significant increase in cardiovascular problems that can result from a continued use of this drug.
The U.S. Food and Drug Administration has issued warnings against Avandia, but the two doctors think that the medical community needs to be even more aware of the problems presented by the Avandia class of drugs and really take this information to heart. In 2007, the FDA first issued a safety alert about Avandia and then later in the year required “black box warnings” for Avandia and similar drugs.
The doctors who sounded the latest alarm are Curt D. Furberg, M.D., PhD, professor of public health, and Sonal Singh, M.D., assistant professor of internal medicine at the Wake Forest University School of Medicine. “We strongly recommend restrictions in the use of thiazolidinediones (the class of drugs) and question the rationale for leaving rosiglitazone on the market,” they said. Avandia is a rosiglitazone drug. The thiazolidinedione drugs were originally approved based on their ability to reduce blood sugar.
The concerns expressed by the doctors stem from the findings of three separate studies: ACCORD, ADVANCE and the Veterans Affairs Diabetes Study. In ACCORD, those patients who received intensive treatment to control their blood sugar had more cardiovascular disease and higher death rates than persons given more standard treatment. In ADVANCE the control of blood sugars showed no effect or benefit from the drugs over standard treatment. In the VA study, the reduction of blood sugar levels produced low levels of consciousness or unconsciousness and was also found to predict future cardiovascular events. “The unfavorable findings from the three trials have not been fully realized by the medical community,” the doctors said.
Part of the risk in taking these drugs may stem from the fact that a reported 22 percent of diabetics already suffer from some form of heart disease. It is further noted that in elderly patients, over half will develop some form of congestive heart failure over a 10-year period. According to Drs. Singh and Furberg’s research they reported in an article
The following drugs in the thiazolidinediones class of anti-diabetic drugs that currently must display a “black box warning” are: Avandia (rosiglitazone), Actos (pioglitazone), Avandaryl (rosiglitazone and glimepride), Avandamet (rosiglitazone and metformin) and Duetact (pioglitazone and glimepride).
“Safer, cheaper and more effective treatment alternatives are available that do not carry these negative cardiovascular risks in patients with diabetes,” said Dr. Singh.
http://www1.wfubmc.edu/News/NewsARticle.htm?ArticleID=2432 and the U.S. Food and Drug Administration. “Manufacturers of Some Diabetes Drugs to
Strengthen Warning on Heart Failure Risk.” August 2007. http://www.fda.gov/bbs/topics/NEWS/2007/NEW01683.html and “FDA Issues Safety Alert on Avandia.”
May 2007. http://www.fda.gov/bbs/topics/NEWS/2007/NEW01636.html
Diabetes Carein 2007, “Thiazolidinediones doubled the risk of congestive heart failure in patients with type-2 diabetes. The increased heart failure appears to be a class effect.”Source: Wake Forest University School of Medicine. “Class of Diabetes Drugs Carries Significant Cardiovascular Risks.” August 2008.
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