Warning Label Urged for Avandia

posted on:
July 31, 2007

author:
Staff

Gaithersburg, Md. – A Food and Drug Administration advisory panel on Monday found that people who use the popular diabetes pill Avandia face a greater risk of heart attack and urged the FDA to slap its strictest warning on its label.

The panel, however, did not go as far as to suggest pulling the drug off the market as one high-profile FDA safety reviewer had urged in his testimony Monday. The agency typically follows the recommendations of its panels but is not bound to do so.

Still, the committee's recommendation is a blow to Avandia's maker, GlaxoSmithKline PLC, which submitted its own studies that showed the drug had no greater risk of heart attack than other drugs.

The panel's recommendation comes amid a storm of criticism heaped upon the British drug giant and the FDA from members of Congress and consumer groups after it was revealed that the drugmaker knew about potential risks associated with the pill for more than a year.

In turn, critics of the FDA have urged Congress to provide the agency with more money to police drugs after they are on the market. The debate has raged since May when the New England Journal of Medicine published a study showing Avandia had increased risks of heart attacks.

More than 20 million Americans and an estimated 170 million people around the world have diabetes, a disease that affects the amount of insulin and sugar in a person's body. The most common form of diabetes is Type 2, in which the body does not produce enough insulin or effectively use insulin. People with Type 1 diabetes produce virtually no insulin of their own.

"The committee felt strongly that there was an increased risk," said Dr. Clifford Rosen, the committee chair from the Maine Center for Osteoporosis Research and Education, who described the panel's decision to issue warnings as overwhelming. "People are going to have to think twice before prescribing this medicine."

Avandia generated $3.3 billion in worldwide sales last year, but analysts estimate those sales have been tailed off more than 20 percent this year following the publication of the studies in May.

Since the New England Journal study, doctors have been moving patients away from Avandia. According to a recent analysis of doctor-prescribing patterns by New Jersey-based market research firm ImpactRx Inc., primary-care doctors are prescribing the drug at less than 5 percent. With the warning and publicity surrounding Monday's FDA advisory panel, including harsh testimony from one FDA official, Avandia's sales could suffer even more.

"Avandia increases the risk of cardiovascular risk compared to its non-use," said FDA safety reviewer David Graham, who has been critical of his own agency's handling of surveillance of drugs once they have reached the market.

Graham said he believed Avandia should be removed from the market. In his testimony, Graham said 70 percent of all diabetes patients eventually die of heart disease so any drug that raises that risk is "unacceptable."

"A wrong decision will cost thousands of lives," he told the joint meeting of two Food and Drug Administration advisory panels: the Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee.

"Avandia has not demonstrated long-term health benefits related to cardiovascular disease," Graham told the panel. "Given these conclusions, are there definitively documented population-level health benefits to Avandia to justify its continued marketing? No."

Meanwhile, Actos, sold by Deerfield-based Takeda Pharmaceuticals North America Inc. and the only other drug in Avandia's class, could benefit.

Avandia and Actos have been taken by more than 16 million Americans since they were launched in 1999, bolstered by a rise in obesity that has sparked an increase in the number of people with diabetes. The pills work by increasing the body's sensitivity to insulin and are the only two drugs in the class of diabetes drugs known as thiazolidinediones.

Avandia and Actos are already in the process of getting warnings in their labels over risks of heart failure which can affect proper blood flow.

Actos was largely spared criticism from the panel and critics who testified. The pill generates the bulk of Takeda's $2.5 billion in annual sales and has been benefited from an increase of prescriptions since May.

While most who testified said Actos has not been as aggressively studied as Avandia, Graham said "it's not increasing the risk" of heart attacks as Avandia does. "If anything, it might be decreasing the risk," Graham said.

But Avandia had a lot of support among studies presented Monday. For example, health insurance giant Wellpoint Inc. of Indianapolis said it found no higher increase in the risk of heart attacks over other diabetes drugs in an analysis of about five years of claims data. The experience of more than 22,000 patients on Avandia as well as more than 24,000 on Actos and more than 120,000 patients treated with other diabetes pills was examined by Wellpoint.

Wellpoint's evaluation appeared to support that of Avandia's maker, GlaxoSmithKline, which testified the FDA that showed "there is no overall evidence that Avandia is different from other oral anti-diabetic agents," including Actos.

"Avandia is an important option," said Dr. Ronald Krall, senior vice president and chief medical officer at GlaxoSmithKline.

Several diabetes advocates spoke out in support of Avandia and urged the committee to keep it on the market. The American Diabetes Association, for example, weighed in with a recommendation that Avandia should remain on the market "because the increased risk of heart attack has not been proven conclusively."

However, the association said Avandia should "probably" carry a warning because there is "enough concern."

Critics said there are ample diabetes treatments on the market aside from insulin. 

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