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Avandia Must Carry FDA's Strongest Warning

Posted by Jane Akre
Thursday, November 15, 2007 12:39 AM EST
Category: Major Medical
Tags: Avandia, Actos, Avandia Heart Attack, Diabetes Drugs

Avandia is proving again to be a controversial drug for the Food and Drug Administration.

For more on Avandia, please see InjuryBoard's Avandia information page.

Avandia Information Page

The FDA announced Wednesday that Avandia, (rosiglitazone), a drug used to treat Type 2 diabetes, would begin to carry a “black box” warning on its label, the strongest warning that a drug can be forced carry.

The warning falls short of a conclusive indictment of Avandia, the subject of strong criticism since a May report in the New England Journal of Medicine found a 43 percent increase in the risk of heart attack compared to a control group.

Dr. Steven E. Nissen, a cardiologist at the Cleveland Clinic who published the May study tells the New York Times the warning “is a step in the right direction but it lacks clarity and could be difficult for some clinicians to interpret.”

The FDA is uncertain whether that is enough compelling evidence to pull the drug from the market citing conflicting results related to the risk of chest pain, heart attacks and heart-related deaths, and deaths from any cause in patients treated with Avandia.

And the FDA is not confident that driving patients to competitor Actos, made by Takeda Pharmaceuticals, does not carry a similar risk.

Patients taking Avandia are advised to be monitored by their doctor.

Meanwhile maker GlaxoSmithKline PLC (GSK) has agreed to put Avandia through a long-term study to evaluate the potential for cardiovascular risk. 

Last May, the FDA issued a strong safety alert for Avandia pointing to its potential significant increase in the risk of heart attack or heart-related deaths but said it, “had not confirmed the clinical significance of the reported increased risk in the context of other studies.”  

Avandia was again the focus of last July’s meeting of two FDA advisory committees that ultimately sent a confusing message to the public and highlighted the FDA’s credibility gap and divisions within the agency, according to a report by Consumers Union.

The FDA’s Dr. David Graham, who had been a whistleblower in drug hearings concerning Merck’s Arcoxia, found Avandia competitor, Actos has a 25 percent lower risk of heart attack among the other members of the thiazolidinedione class of diabetes treatments. 

Graham argued Avandia increased cardiovascular risk and had no special ability to control blood sugar in diabetics and should be pulled from the market. 

But an advisory panel voted 22 to 1 to keep Avandia on the market. Eventually a panel of government experts used to settle internal disputes was brought in to quiet dissent within the agency also voting to keep Avandia on the market.

Avandia was approved in 1999 to compliment diet and exercise in addressing a diabetic’s blood sugar levels.

Seven million patients have taken it over seven years and Avandia generated $2.2 billion in profit for GSK in 2006.

Following the May analysis, GlaxoSmithKline PLC lost 8 percent or $13 billion in one day.  Shares fell to 57 cents to $50.03 following Wednesday’s news. #




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