FDA Hearings on the Drug Avandia

The U.S. Food and Drug Administration opens hearings into the safety of the diabetes drug Avandia on Tuesday after a strongly worded report that suggested the drug may be more dangerous than previously reported.

An FDA advisory panel will hear two days of testimony about the drug, and will end up voting whether or not to remove the drug from the market.

Avandia is used to control blood sugar levels in diabetics.

Its manufacturer, GlaxoSmithKline, says several trials have shown the drug is safe. However its usage has fallen drastically since a 2007 study concluded that Avandia raised the risk of heart problems, proving otherwise.

FDA released a report Friday, sharply criticizing a Glaxo study released, known as RECORD, which painted a more reassuring picture of the drug. RECORD found no increased risk of heart problems.

But the FDA found that Glaxo researchers repeatedly submitted poor data and failed to follow up on reports of problems in patients -- including reports of patient deaths.

The author of the FDA analysis, Dr. Thomas Marciniak, called the study's engineering "inappropriate and biased."

Glaxo's vice president for clinical development, Dr. Murray Stewart, said last week that six clinical studies -- not just the one criticized by the FDA -- "show that this medicine does not increase the overall risk of heart attack, stroke or death."

In May of 2007 the FDA issued a safety alert for heart attacks and cardiovascular events for those taking Avandia. In August of 2007, the FDA made Glaxo issue a Black Box Warning about Congestive Heart Failure, which is a very serious warning aimed at informing the public and prescribing doctors of problems associated with the drug.

Clearly the FDA realized there was a problem with the drug in 2007. Hopefully this year when they vote, they will vote to remove Avandia from the market.

Our firm has been reviewing cases where people have suffered health problems due to taking the diabetes drug Avandia. If you or a loved one has experienced side effects of Avandia call the Anderson Law Firm today. We can be reached toll free at 877.294.1115 or you can contact us online for a free consultation.