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Draft Study Links Avandia to Thousands of Heart Attacks, Strokes

Jun 11, 2010 | Parker Waichman LLP

An unpublished Avandia study has found that patients in the U .S. Medicare system who took the drug may have suffered as many as 48,000 heart attacks, strokes and other problems between 1999 and 2009. According to the study’s author, Dr. David Graham, a safety official with the U.S. Food & Drug Administration (FDA), the problems could have been averted had the patients taken a different drug.

According to The Wall Street Journal, Dr. Graham is a long-time critic of the controversial diabetes drug. The findings of his study will be included in data presented at a meeting next month to review Avandia’s safety. Dr. Graham and others have argued that Avandia should be withdrawn from the market.

For the study, which was authenticated for the Journal by the FDA, Dr. Graham and colleagues from the FDA and Centers for Medicare and Medicaid Services retrospectively examined the medical records of 227,000 patients 65 and older. The patients took either Avandia or a competing drug, Actos, between 2006 and 2009. Many of the patients also took other diabetes drug treatments. Patients taking Avandia had a 27 percent greater chance of suffering a stroke, a 25 percent increased risk of suffering heart failure and a 13 percent greater chance of dying, the study found.

“There is no rationale for [Avandia's] continued availability on the market or its use by prescribing physicians or patients,” the researchers conclude.

According to the Journal, the unpublished study was first reported by the blog, Pharmalot, in May. The blog also published an email from Dr. Graham to the FDA’s senior leaders, in which he complained that the agency was holding up his efforts to publish his work in the Journal of the American Medical Association (JAMA).

An FDA official confirmed the email, but said the agency wasn’t preventing publication of the study. A JAMA spokeswoman said the journal doesn’t ever confirm or deny receipt or acceptance of any manuscript until publication, The Wall Street Journal said.

Avandia has been the subject of safety concerns for several years. In November 2007, a black box warning – the FDA’s strongest safety warning – detailing Avandia’s association with myocardial ischemia was added to the drug’s labeling. The black box was added after the Cleveland Clinic published a meta- analysis of 42 clinical trails that showed patients taking Avandia had a 43-percent higher risk of having a heart attack.

Earlier this year, the Senate Finance Committee released a report detailing its 2-year Avandia investigation. According to the report, in July 2007 the FDA’s own scientists estimated that Avandia was responsible for more than 80,000 heart attacks.

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