Diabetes drug Avandia faces new, strict limitations from the U.S. and European drug regulatory agencies due to its substantial risks to the heart.

Use of Avandia will be severely restricted in the United States; it will only be prescribed to patients who have tried every other diabetes drug, and have been informed of the potential risk for Avandia heart problems. Europe has completely suspended sales of the diabetes drug.

Avandia Linked to Heart Attacks, Cardiovascular Problems

Once a popular drug to treat Type 2 diabetes, Avandia suffered a significant decline in sales after a 2007 study linked the prescription medication to serious heart problems.

According to a report published in the New England Journal of Medicine, Avandia can significantly increase the risk of heart attack and cardiovascular-related death, particularly in patients with a history of heart disease or other risk factors that may make them susceptible to a heart attack. After the report surfaced, the FDA issued a safety alert urging patients taking Avandia to speak with their doctors about other treatment options.

One study suggests that between 1999 and 2009, nearly 50,000 patients taking Avandia suffered a stroke, heart attack, heart failure or died. Additionally, a meta-analysis of 40 studies found that Avandia increases a patient’s risk of heart attack and heart-related death by 30 to 40 percent when compared with a placebo or another diabetes drug.

Avandia reduces the body’s resistance to insulin, but can also cause fluid retention—a risk factor for congestive heart failure. Because of the serious side effects of Avandia, the FDA announced that it would no longer approve drugs simply because they help control blood sugar levels in diabetes patients.

Rather, the FDA will require drug manufacturers to conduct two-year clinical trials to demonstrate that their drugs do not harm the heart and lengthen the life expectancy or improve the quality of life for diabetics.

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