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News Articles >> Scientists Demand Action on Avandia: New..
Scientists Demand Action on Avandia: New FDA Panels Formed
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| July 8, 2007. By Anne Borden |  RSS  Del.icio.us  Seed Newsvine  Facebook |
Cleveland, OH: At the recent American Diabetes Association's annual meeting in Chicago, Dr. Steven Nissen, chief of cardiology at the Cleveland Clinic, said early data on links between Avandia and cardiac events were ignored by the drug's maker, Glaxo Smith Klein, including findings presented at the FDA advisory meeting prior to Avandia's approval.
"The FDA rushed to approve [Avandia]", said Dr. Nissen. "In my view that was a regulatory mistake. A strong safety signal of excess cardiovascular events was ignored."
Avandia is part of a class of drugs which have been linked to liver and cardiovascular issues. Avandia labels warn of increased risk of congestive heart failure and rare but serious liver problems. In fact, the first drug in Avandia's class, Rezulin, was pulled from the market in 2000 after more than 60 people died from acute liver failure.
Kept in the Dark
Dr. Nissen spoke to a packed audience of diabetes experts and other doctors, in a session that was added to the conference at the last minute. The conference was attended by about 13,000 doctors and researchers. Dr. Nissan answered questions and addressed one physician's concerns that the findings could cause a panic among patients.
"The alternative was unacceptable: to keep the scientific community in the dark," said Dr. Nissen.
Questions about Avandia erupted early this summer when the New England Journal of Medicine published an analysis by Dr. Nissen that stated the widely used drug raised heart-attack risk by 43 percent. Nissen's study found that patients given Avandia were more likely to have a heart attack or be hospitalized for blocked coronary arteries.
New FDA Advisory Panels
In response to Dr. Nissan and other researchers' concerns, U.S. regulators have asked for stronger warnings on Avandia and are studying whether or not the drug should remain on the market.
Reuters reports that two advisory separate panels of the FDA are scheduled to study the issue of Avandia's safety at a series of meetings starting July 30. The endocrine and metabolic drugs committee and the drug safety and risk management committee will meet simultaneously, an FDA agency notice said.
The advisory panel will discuss the cardiovascular risks of the class known as thiazolidinediones, "with a focus on rosiglitazone," said an FDA statement. Rosiglitazone is the generic name of Avandia.
A Recall in the Works?
In advance of the new FDA panels, a congressional hearing was held June 6 to address the issue of risks relating to Avandia. That same day, the FDA asked Glaxo Smith Klein to put a Black Box warning on the Avandia packaging, prompting speculation that there could be a product recall.
"Before the study, the health risks were virtually ignored," says one health watchdog. "But this has turned into a public relations nightmare for [Glaxo Smith Klein], with new lawsuits in the newspapers every day. Sometimes that's what it takes for a company to act."
Drug Maker on the Defensive
USA Today reports that prescriptions for Avandia have dropped about 10% since Dr. Nissen's study was published. Many doctors are switching their patients to Actos, a similar drug, to respond to safety concerns.
The stakes are high for Glaxo Smith Klein: some 60 million prescriptions have been written for Avandia and the drug generates about $3 billion in annual sales. The drug company recently took out full-page newspaper ads to reassure the public that it stands behind Avandia. According to a spokeswoman for the New York Times, the newspaper charges $110,000 for a full-page ad.
What You Can Do
If you are currently taking Avandia, speak to your doctor. If you have experienced negative health effects that may be associated with Avandia, you should also speak with a legal professional about your options.
Avandia Legal Help
If you or a family member have used Avandia and have suffered heart attack or liver damage after taking Avandia, please contact a lawyer involved in a possible [Avandia Lawsuit] who will review your case at no cost or obligation.
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