Posts Tagged ‘drug safety’

Dr. Sidney Wolfe, director of Public Citizen's Health Research Group


By failing to ban the dangerous diabetes drug, Avandia, generic name rosiglitazone, the Food and Drug Administration (FDA) again caved to industry pressure. Although the FDA has made progress highlighting the risks of using Avandia by severely restricting the drug, it did not go far enough. Too many people could still be exposed to this dangerous product. Rather, the FDA should have acted with its European counterpart and outright banned Avandia from the market.

Why did it take the FDA so long to decide that a drug with no evidence of any advantage in health benefits, but abundant evidence of a variety of risks compared to other diabetes drugs, should be severely restricted? Why did it not ban this unsafe product?

More than three years ago at an FDA advisory committee meeting, Public Citizen urged the FDA to ban Avandia. Since then, 9 million prescriptions for the drug have been filled in the United States. This means that, just in the past three years alone, tens of thousands more patients have needlessly suffered hospitalizations for heart failure or deaths than would have had they taken Actos, a comparable, but safer drug.

There is not a single study finding that Avandia is safer than Actos, but there are numerous studies finding that Avandia is more dangerous than Actos. The FDA and GlaxoSmithKline have acted recklessly in allowing Avandia to stay on the market for so long after its unique dangers have been known.

The FDA should reconsider its decision to merely restrict such a hazardous product and directly remove it from the market.

Public Citizen petitioned the FDA in 2008 to ban Avandia.

Click here to learn more about Public Citizen’s work on Avandia.

Dr. Sidney Wolfe is the director of Public Citizen’s Health Research Group.

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Photo by Bridgette Blair

Taking a mislabeled drug or using a defective medical device is a dangerous thing. Just ask actor Dennis Quaid and his wife, Kimberly.

In November 2007, their newborn twins were given a massive overdose of Heparin, an anticoagulant drug. The twins were supposed to receive another drug that would ease the intravenous administration of antibiotics. Why were they given the wrong medication? The two drugs’ labels were similar. Baxter Healthcare Corp., the manufacturer of both drugs, was aware of the problem – in 2006, the same confusion over the labeling of Heparin caused the death of three infants at an Indianapolis hospital. Baxter relabeled Heparin to avoid this confusion before the Quaid twins were born. But here’s the shocker: The company didn’t recall the drug stock with the confusing label, so it remained on pharmacy shelves and was eventually injected into the twins.

The twins survived, barely.

Dennis Quaid made his way to the Hill this morning to tell his and his wife’s story at a Congressional hearing, and Public Citizen attorney Brian Wolfman accompanied them as part of their legal counsel. (Wolfman, director of the Public Citizen Litigation Group and a preemption expert, has written an article about preemption and why its proponents are wrong in TRIAL Magazine.) (more…)

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