Avandia has been shown in studies to increase the risk of stroke. In April 2007, the U.S. Food and Drug Administration (FDA) approved safety labeling revisions to advise of the increased risk for cardiovascular events associated with use of rosiglitazone maleate tablets in patients with New York Heart Association class 1 and 2 cardiac status; the risks for stroke, and deep vein thrombosis.
*** Avandia® Labeling Update 2/4/11: The FDA has notified healthcare professionals and patients that information on the cardiovascular risks (including heart attack) of Avandia (rosiglitazone) has been added to the physician labeling and patient Medication Guide. Additionally, the drug labels have been revised to state that rosiglitazone and rosiglitazone-containing medicines should only be used:
- In patients already being treated with these medicines
- In patients whose blood sugar cannot be controlled with other anti-diabetic medicines and who, after consulting with their healthcare professional, do not wish to use pioglitazone-containing medicines (Actos, Actoplus Met, Actoplus Met XR, or Duetact).
What’s the problem?
An unpublished Avandia study has found that patients in the U .S. Medicare system who took the drug may have suffered as many as 48,000 heart attacks, strokes and other problems between 1999 and 2009. According to the study’s author, Dr. David Graham, a safety official with the U.S. Food & Drug Administration (FDA), the problems could have been averted had the patients taken a different drug.
For the study, which was authenticated by the FDA, Dr. Graham and colleagues from the FDA and Centers for Medicare and Medicaid Services retrospectively examined the medical records of 227,000 patients 65 and older. The patients took either Avandia or a competing drug, Actos, between 2006 and 2009. Many of the patients also took other diabetes drug treatments. Patients taking Avandia had a 27 percent greater chance of suffering a stroke, a 25 percent increased risk of suffering heart failure and a 13 percent greater chance of dying.
Avandia Stroke Signs & Symptoms
Signs and symptoms of an Avandia-induced stroke may include (but are not limited to):
- Weakness or numbness in the arm, leg, face, or even an entire side of the body
- Confusion, difficulty speaking and understanding
- Blurred vision
- Dizziness, vertigo, loss of balance
- Sudden severe headaches