FDA says Glaxo didn't report Avandia data

According to a new letter from the agency, GlaxoSmithKline didn't turn over post-marketing data about Avandia to the FDA, a lack of disclosure that looks pretty unfortunate given subsequent reports linking the blockbuster drug to an increased risk of heart attack. To be fair, many drug companies fail to report post-approval data to the FDA once they begin selling a drug, as the rules are pretty loose as to when and how they do so. But in Glaxo's case, the failure to report arguably could have harmed consumers, given the risks exposed by last year's article in the New England Journal of Medicine. The agency now is demanding that the company turn over all data on Avandia, pronto, or risk regulatory action.

To learn more about the FDA's actions:
- read this Triangle Business Journal piece

Related Articles:
Vytorin, Avandia raise doubt on FDA approvals. FDA report
Avandia gets black-box warning. Avandia report
Avandia critic says FDA launched smear campaign. FDA report
MD leaked Avandia results to GSK. Avandia report

Post a comment