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Monday, March 4, 2024

FDA, government debate pulling popular diabetes drug

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Diabetes sufferers now face the possible risk of developing heart failure, a new study found last week.

If patients are taking either diabetes drug Avandia or Actos it’s a possibility that they face twice the risk of being diagnosed compared to people not on the popular medications. According to the August issue of Diabetes Care, of every 50 patients with type 2 diabetes taking these drugs, one patient will develop heart failure within 26 months.

“We know these drugs increase the risk, but we found the risk is more substantial than suspected,” said Dr. Donal Singh, lead author of the study. “This occurs at even the lowest dose and among young patients.”

The report follows a U.S. government report also released last week, which found Avandia’s heart risks are far higher than Acots’.

The government study, which was compiled by a medical and safety review team at the FDA, found that Avandia is especially harmful to patients who are already on insulin whereas Actos users can take insulin as well without fearing cardiac side effects, the New York Times reported.

FDA scientist Dr. David Graham says because of such dangerous risks, Avandia should be pulled from the market.

“Those risks,” he says. “Combined with no unique short-term benefits in helping diabetics control blood-sugar levels, fail to justify keeping Avandia on the market.”

However, government health advisors said Monday, they believe the widely used drug should not be pulled saying evidence of an increased risk of heart attack doesn’t merit removal. At Recorder press time, neither the FDA nor the government had decided whether or not to prohibit the drug.

The manufacturer, GlaxoSmithKline argued that there is no increased risk citing its own analyses of studies on Avandia.

“The number of myocardial infarctions is small, the data are inconsistent and there is no overall evidence (Avandia) is different from any other oral antidiabetes agents,” said Dr. Ronald Krall, the company’s senior vice president and chief medical officer.

About 1 million Americans with type 2 diabetes use Avandia to control blood sugar by increasing the body’s sensitivity to insulin. According to the FDA, that sort of treatment has long been presumed to lessen the heart risks already associated with diabetes, which is linked to obesity. News that Avandia might actually increase those risks would represent a “serious limitation,” the FDA said.

Information from the Associated Press was used in this article.

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