NPR logo Avandia Gets Tougher Label, As Glaxo Reportedly Settles Lawsuits

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Avandia Gets Tougher Label, As Glaxo Reportedly Settles Lawsuits

European regulators decided to take Avandia off the market. FDA allowed further sales, with heavy restrictions. Justin Sullivan/Getty Images hide caption

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Justin Sullivan/Getty Images

European regulators decided to take Avandia off the market. FDA allowed further sales, with heavy restrictions.

Justin Sullivan/Getty Images

Prescriptions for Avandia, a diabetes drug, started falling years ago as evidence about heart risks from the drug mounted.

Now, the drug, which remains on the market in the United States but with lots of restrictions, got tougher warnings the Food and Drug Administration had ordered.

The changes spell out just how rarely Avandia should be prescribed. The drug's instructions now say it should only be used for patients already taking it (or a related medicine like Avandamet). And the only new patients who should get the drug are those who can't control their blood sugar with other medicines or can't use rival pill Actos for some medical reasons.

In September, FDA Commissioner Margaret Hamburg predicted the number of people taking Avandia would decline dramatically from around 600,000 at the time. She was right. Glaxo told Shots about 100,000 people in the U.S. are taking Avandia these days.

Separately, Bloomberg reported Glaxo has agreed to pay $250 million to settle a couple thousand lawsuits claiming the drug injured or killed people taking it. The Glaxo spokeswoman declined to comment on the report to Shots.

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