Avandia's labeling information revised

PHILADELPHIA — GlaxoSmithKline has changed prescribing information on the labeling for one of its Type 2 diabetes drugs to reflect new restrictions on the drug’s use, the drug maker said.

GSK said it revised the labeling for Avandia (rosiglitazone) to take into account the risks of heart attacks and heart failure in patients taking the drug.

The FDA moved to restrict access to Avandia last year and required GSK to create a risk evaluation and mitigation strategy for the drug.

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Comments

- 8:30 PM
canes1212 says

This label change is long
This label change is long overdue. Many patients lives could have been saved if this warning was placed when GSK knew of the problems related to MI's, CHF and Strokes. It is now GSK's responsibility to pay damages to those who have suffered from this medication.

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