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In the News: Heart failure risk prompts warning labels on diabetes drugs

In the News

Heart failure risk prompts warning labels on diabetes drugs

The concern now is whether this particular class of drugs causes other cardiovascular problems.

In May 2007, the FDA told the makers of two diabetes drugs to add "black box" warnings to their labels because of the risk of heart failure. Both medications — Avandia (rosiglitazone), marketed by GlaxoSmithKline, and Actos (pioglitazone), by Takeda Pharmaceuticals — are thiazolidinediones. This class of drugs lowers blood sugar by increasing insulin sensitivity in liver and muscle cells. Insulin is the hormone that moves sugar from the blood into cells. The FDA announced the call for labeling revisions during a Congressional hearing on reports linking Avandia to heart attacks and cardiovascular death.

Avandia made headlines on May 21, 2007, with the expedited release of a study in the New England Journal of Medicine (NEJM) suggesting that the drug increases the risk of having a heart attack by 43% and dying from cardiovascular disease (CVD) by 64%. The study's authors, from the Cleveland Clinic, analyzed 42 controlled trials comparing Avandia to placebo or a different diabetes drug in a total of 28,000 subjects. Avandia takers had 82 heart attacks and 39 CVD deaths, while those in the control groups had 72 heart attacks and 22 CVD deaths. Although the number of these events was small, the prospect of a diabetes drug causing heart problems is worrisome. People with diabetes are already at high risk for heart disease.

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