Avandia Pulled Off the Market? Is an Avandia Recall Near?
The popular GlaxoSmithKline diabetes drug Avandia may soon be pulled off the market by the Federal Food & Drug Administration because of the dangerous propensities of the drug. The drug has been known to cause increased risk of heart attacks, stroke, and congestive heart failure in users.
Today marks day two of hearings underway by the FDA ro determine whether the FDA will pull Avandia off of the market and force a recall of Avandia.
Beginning Tuesday, the 33 members of the FDA's advisory committee began a hearing to determine whether or not to recall Avandia. During the first day of hearings, a safety study by GlaxoSmithKline came under attack throughout the hearing.
"You can't trust it, and if we do trust it, we're engaging in the willing suspension of disbelief," said FDA scientist Dr. David Graham.
Last week, in a strongly worded FDA report, the company's study was called "inappropriate and biased." The FDA said that GSK repeatedly submitted sloppy data and failed to follow up on reports of problems among patients, including deaths.
The FDA panel could vote as early as today on whether to remove Avandia from the market.
Published estimates indicate sales of Avandia have dropped from about $3 billion in 2006 to about $1 billion.
In a study published in June, Dr. Graham found that patients on Avandia are more likely to suffer stroke, heart failure or premature death than patients who used another drug.
GSK also "failed to publish studies that found serious health risks associated with Avandia in a timely manner and actively promoted the drug despite the known safety concerns" according to the Senate Finance Committee.
Bahe Cook Cantley & Nefzger attorney says, "I applaud the FDA for finally forcing the makers of Avandia to answer the tough questions about this drug. It has caused numerous instances of heart attack, stroke and congestive heart failure, which in turn has caused numerous families to suffer the heartache of losing a loved one. If GSK wanted to make billions off of a drug, it should have carefully tested Avandia before putting it on the market. Instead, GSK put profits over people and hid the bad data about Avandia."
