Toll-Free: 800-354-6275
Phone: 817-294-1900
Federal health experts voted Wednesday that GlaxoSmithKline's drug Avandia should stay on the market, but the much-debated diabetes medication will have new restrictions due to uncertain heart side effects. A panel of Food and Drug Administration advisers voted 20-12 to keep the pill available for diabetics. However, 10 panelists also called for limiting who can receive and prescribe the controversial drug.
The vote favors the British drug company Glaxo, which is facing thousands of lawsuits from patients who say Avandia caused their heart attacks or strokes. While the ruling may help the company in court, sales of Avandia are expected to drop drastically.
In the past the FDA has followed to advice of the panelists, however the FDA is not required to do so. FDA officials said they would review the recommendations and make a decision on Avandia as soon as possible. In an earlier ruling Panelists voted 21-4 that Avandia is more likely to cause heart attack than its closest competitor Actos. Eight panelists said there was not enough information to make a decision.
Ultimately though, panelists said the risks were not severe enough to justify removing a pill used by hundreds of thousands of patients.
The FDA first approved Avandia in 1999 and it quickly became the top-selling diabetes drug in the world. Recently U.S. sales have plummeted from $2.2 billion in 2006 to $520 million last year as safety risks began to be publicized.
The drug works by increasing the body's sensitivity to insulin, a key protein that diabetics don’t adequately produce.
While there are more than a dozen diabetes drugs on the market, only Actos from Japan-based Takeda Pharmaceuticals works the same way as Avandia. U.S sales of Actos have risen steadily — hitting $3.4 billion last year — as Avandia's name has been questioned.
Critics of Avandia say there is no reason to leave the medication on the market when Actos provides the same benefits without the potential heart risks.
FDA is requiring GlaxoSmithKline to conduct a definitive study comparing the safety of the two drugs, but patient enrollment has been slow due to Avandia's negative reputation.
The FDA panel said the study should proceed, though results will not be available for at least five years.
While, originally I had hoped they would vote to remove Avandia from the market, I am still happy about the outcomes of the drugs hearing. The panel acknowledged that Avandia has risks; they just couldn’t find enough evidence and data to remove the drug from the market. With their decision to conduct a comparison study they will get the information they need to make an informative decision.
I wish the study would have been started earlier so we could the results sooner, but I am willing to wait five years to get the correct information on this controversial medication.
Information and commentary is provided by Personal Injury Attorney Mark Anderson. 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.
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.
15 Mistakes That Will Wreck Your Texas Accident Case!