TIME: Glaxo Knew of Avandia Heart Attack Risk


. By Charles Benson

New sealed court proceedings obtained by TIME Magazine reveal that drug maker GlaxoSmithKline may have known about the increased risks of Avandia heart attacks before it convinced the US Food and Drug Administration that studies linking the diabetes drug to heart attacks were inconclusive.

In 2007 representatives of the pharmaceutical giant met with FDA officials and told them that studies of Avandia "yielded information that is inconsistent with an increased risk of myocardial ischemic events," according to the documents obtained by the news provider.

However, two days before that meeting, GlaxoSmithKline's Global Safety Board said that a new study of the medication "strengthens the [cardiac-risk] signal observed in the [previous] analysis."

According to TIME, a number of days before the internal safety board noted the recent study, Moncef Slaoui, the company's head of research and development, sent an e-mail to GlaxoSmithKline's chief medical officer that said Avandia takers showed an "increased risk of ischemic event ranging from 30 percent to 43 percent!"

Shortly after the drugmaker's meeting with the FDA, the New England Journal of Medicine showed that Avandia could increase the risk of heart attacks by 43 percent.


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