Orlando Injury Lawyers Discuss FDA Action on Avandia
As Orlando injury lawyers handling drug product liability claims, the Food and Drug Administration’s handling of the drug Avandia is disturbing. According to Senate investigations, the Food and Drug Administration's safety staff concluded that the prescribing information for the drug should have included the most serious warning. Yet the FDA mandated no such warning.
It has come to light that FDA staff found that the risk of congestive heart failure, a condition in which the heart can't pump enough blood through the body, demanded a black box warning, the most serious type of alert. However, without satisfactory explanation, the FDA did not follow staff recommendations and instead, inserted the warning about congestive heart failure risks with Avandia on line 351 of the label. Essentially, this serious risk was buried.
Why did GlaxoSmithKline Plc's diabetes drug not carry the strongest possible warning about congestive heart failure? Interestingly, after an analysis by the New England Journal of Medicine found patients on Avandia to be 43 percent more likely to have a heart attack, lawmakers began raising questions about the FDA's handling of Avandia. The risk of the drug causing congestive heart failure is another concern over this federal agency’s handling of this diabetes drug.
While the FDA is still reviewing data on Avandia's heart-attack risks, it is interesting to note that Avandia was approved in the U.S. in 1999, and is the world's top-selling diabetes pill and had $3 billion in sales last year. Perhaps the need to get important drugs to market should be better balanced with the need to ensure proper warnings accompany them.
