WASHINGTON — GlaxoSmithKline says it has updated the labeling of its diabetes pill Avandia to include safety restrictions ordered by federal health authorities because of the drug's links to heart attack.
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The Food and Drug Administration announced the changes in September as the latest safety action against the former blockbuster drug, which has triggered thousands of lawsuits and a Department of Justice investigation. The pill is banned in Europe.
The new U.S. label indicates the drug is only intended for patients who cannot control their blood sugar with any of the other diabetes medications on the market.
The FDA first approved Avandia in 1999 and it became the top-selling diabetes pill in the world by 2006. But use has plummeted since a 2007 analysis linked the drug to heart attack.
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