FDA Panel does not recommend Avandia recall
Monday an FDA advisory panel reviewed whether there should be an Avandia recall, but recommended that the type 2 diabetes drug remain on the market with stronger warnings regarding the heart risks. Although the panel voted 20 to 3 that Avandia does increase the risk of heart attacks, they did not believe that sufficient evidence exists at this time to recommend a recall.
>>PRIOR POST(7/26/07): Avandia Recall to be reviewed by FDA
The FDA convened the panel of experts to evaluate what actions should be taken to protect the public. Recent studies demonstrate that users face a 43% increase in the risk of heart attacks and a 64% increase in the risk of heart related death. Although the FDA is not required to follow the recommendations of their advisory panels, they usually do.
Strong disagreements existed within the FDA community about whether Avandia should remain on the market. Two FDA scientists testified before the advisory committee that the drug should not be sold in the U.S. According to a presentation made by Dr. David Graham, the combination of no unique short term benefits in controlling blood sugar levels and the increased Avandia heart risks should justify removing the drug from the market.
According to Dr. Graham, the Avandia heart risks could have caused over 200,000 heart attacks, strokes and deaths between 1999 and 2006. He recommended the Avandia recall, estimating that around 2,000 people each month will suffer a heart attack or stroke as long as the drug is sold.
Dr. Sidney Wolfe, a representative from the drug safety advocacy group Public Citizen, indicated that Avandia would not be approved today based on the what we now know about the heart risks and other problems associated with the drug.
Although the committee did not recommend an Avandia recall, they did express concerns regarding the heart risks. The chairman of the advisory committee, Dr. Clifford J. Rosen, indicated that Avandia should not be used by those with congestive heart failure, a history of heart disease or those taking insulin or nitrates. Although there will not be a recall, he anticipates that changes will occur in the way Avandia is promoted and prescribed by physicians.
Approximately 1 million type 2 diabetics in the United States took Avandia in 2006, and the drug generated approximately $3.4 billion in sales. It is the second best selling drug for the manufacturer, GlaxoSmithKline PLC, and they have continued to defend their product to protect the substantial profits it generates.
Since information regarding the heart risks was published in the New England Journal of Medicine in May, sales have fallen sharply and many predict that Avandia sales will plunge further with a prominent heart attack warning.
AVANDIA HEART RISK LAWSUITS
The Avandia lawyers at Saiontz & Kirk are reviewing potential lawsuits against GlaxoSmithKline for failing to provide proper warnings regarding the heart risks associated with their drug. Although the manufacturer was aware of the potential increased risk of heart attacks and death, they did not alert the public or the medical community. As a result, thousands of heart attacks, strokes and deaths have occurred.