Avandia's Black Box Warning
A black box warning is the strongest safety warning issued by the U.S. Food and Drug Administration. Named for their black border, the warnings are supposed to call attention to life-threatening of very serious potential side effects of a drug.
They are the most serious action the FDA can take without recalling a drug or subjecting it to strict regulations. It was this type of warning that the FDA issued for Type II Diabetes drug Avandia, after a study was published showing that Avandia raises its users risk of heart attack by 43 percent and their risk of death from heart problems by 64 percent.
The black box warning on Avandia's label was issued in May 2007 and revised twice in the following six months. The original warning said that Avandia may raise the risk of congestive heart failure; its August revision added a warning that Avandia may raise patients' risk of heart attacks. These revisions have done nothing to silence critics who point out that the warning is written in "medicalese" that not all patients can understand; for example, the label refers to heart attacks as the myocardial infarctions. And of course, many other wonder why the FDA has chosen not to take Avandia off the market altogether, or taken stronger steps to restrict its use.
That question is particularly troubling because emerging evidence shows that the FDA knew about Avandia's cardiac risks before the May 2007 study came out. The agency's own public statements acknowledged that is had "recently" received evidence showing the same safety problems that the New England Journal of Medicine Report uncovered. In Congressional hearings shortly after, it was revealed that some FDA regulators had called for a black box warning months before the study; one expert had sent a letter with concerns as early as 2000. The same hearing revealed that agency officials estimated that Avandia may have caused 60,000 to 100,000 avoidable heart attacks between 1999 and 2006.
Furthermore, regulators elsewhere in the world have reacted more strongly to the news that Avandia causes life-threatening cardiac events. Health Canada has banned the drug's use with multi-drug cocktails or insulin and restricted it to last-resort use for diabetics for whom other drugs have failed.. European Union regulators never approved Avandia for heart patients in the first place, and strengthened Avandia's warning labels there in October 2007.
In the wake of these concerns, Congressional regulators have started asking why the FDA didn't take action sooner, or take more drastic action to protect the public from this potentially dangerous drug. The House Committee on Government Oversight and Reform has held hearings investigating why the FDA has not conducted its own post-market study. These hearings spawned another Congressional investigation when they revealed intimidation tactics by Avandia's manufacturer, GlaxoSmithKline. Dr. John Buse, a diabetes expert, testified that he spoke out on Avandia's potential to increase its users's risk of heart problems in 1999, only to be threatened with a lawsuit by the manufacturer over potential losses to the company. This surprising news spurred another Congressional investigation , but the Senate Finance Committee, which found that GlaxoSmithKline harassed and intimidated the doctor. The investigation also found that the manufacturer, like other drug companies, maintained an overly cozy relationship with the FDA that allowed it to stifle concerns Avandia's relationship to heart problems -- until the independent study was published.
Call us at 1-800-LAW-3333, speak to Attorney Jack Yankowitz and learn how we can help you obtain the justice and financial compensation you deserve.
