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FDA to review diabetes drug’s safety

Ten years after the Food and Drug Administration (FDA) was accused of downplaying the side effects from the popular diabetes drug Avandia, the agency reports that it will reveal the data it is reviewing ahead of an advisory panel meeting about the drug’s safety. The meeting follows two recent drug safety studies that suggest that Avandia may cause serious or life-threatening side effects. A third study appeared to show the opposite. Since 2005, evidence has suggested that the diabetes drug Avandia may increase the risk of cardiovascular complications, including heart attacks, one the major causes of death among diabetes. The drug is still on the market and scientists continue to battle over its safety, leaving patients nervous pending the FDA’s eventual findings about the product side effects.

Avandia acts primarily by increasing insulin sensitivity and improving glycemic control while reducing circulating insulin levels. The drug is not recommended for patients with symptomatic heart failure. Some studies have showed Avandia to be associated with an increased risk of myocardial ischemic events such as angina or myocardial infarction.

Prescription drugs like Avandia along with over-the-counter medications, including generic drugs, are regulated by the Food and Drug Administration’s Center for Drug Evaluation and Research (CDER). Their work, however, covers more than just medicines. They also regulate items such as fluoride toothpaste, antiperspirants, dandruff shampoos, and sunscreens.

For more information about the potential product safety issues with Avandia, click on the link.