Black Box Warning Links Avandia to Heart Attacks

On November 14, 2007, the Food and Drug Administration (FDA) issued its toughest warning against the controversial diabetes pill Avandia, linking it to heart attacks. The new warning, which is outlined by a black box, will be placed on all of Avandia’s prescribing information. This ‘Black Box’ warning carries the strongest advisory and is considered the most serious of the FDA’s warnings issued to health providers and the public. The makers of Avandia, GlaxoSmithKline (GSK), agreed to provide the warning pending a new long-term study comparing the risks of Avandia with those of another oral type two diabetes drug called Actos.

This is the second warning issued by the FDA against Avandia. The first warning was issued in August of 2007 and it warned about the higher risks of heart failure when taking Avandia.

The new warning comes as no surprise to those familiar with the controversy surrounding Avandia this past year. What is surprising though, is that despite it being surrounded by a black box, alerting those of its severity, the message is vague and unclear. In comparison to the Canadian and European warnings of Avandia released this past year, the FDA’s alert seems weakly worded and ambiguous. Health Canada, Canada’s equivalent to the FDA, went as far as to withdraw approval for Avandia as a stand-alone therapy. The FDA’s warning, however, simply states that "the available data on the risk... are inconclusive."

This is not the first time this year Avandia has been in the forefront of the news. In June of 2007 a report in the New England Journal of Medicine linked Avandia to a 43 percent increase risk of heart attacks. This study was conducted by Cleveland Clinic cardiologist Dr. Steven Nissen, one of the doctors who found a link between Vioxx and cardiac risk. In addition, Dr. Nissen and his colleague Kathy Wolki, determined that taking Avandia also increased the risk of dying from cardiovascular causes by 64 percent.

This study brought to light data that had been acquired by GSK during clinical trials, showing a potential link between taking Avandia and heart related deaths. Within hours of the study being made public, the FDA issued an alert based on GSK’s initial data. Last summer, Avandia was the world’s best selling prescription drug for type 2 diabetes. Once the findings were made public, controversy circled Avandia and GSK, and sales of Avandia dropped by about half.

Fueling the controversy was FDA scientist, Dr. David Graham, who publicly chastised the makers of Avandia for having the dangerous drug on the market. During an FDA meeting held on July 30, 2007, an advisory panel found that Avandia increases the likelihood of heart attacks and should carry a new safety warning. It also recommended that the drug remain on the market, while safety assessments continue. As the year closes, the FDA will continue to allow Avandia to be sold as long as it displays the black box warning.

Until then, provided with an ambiguous warning, healthcare professionals as well as the public will carry the burden of deciding whether to trust Avandia as a viable and safe treatment for diabetes.


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