European press doesn’t alarm U.S. players
Manufacturer, FDA, ADA downplay reports
The U.S. Food and Drug Administration (FDA), the American Diabetes Association in Alexandria, VA, and SmithKline Beecham in Philadelphia are all downplaying a European report linking the new insulin resistance treatment, rosiglitazone, to liver toxicity.
The three agencies that often have different agendas when it comes to treating diabetics agree that a report in the British pharmaceutical trade magazine Scrip should not be cause for concern.
Scrip reported in late September that the FDA had received reports of adverse liver events in 25 patients taking rosiglitazone, marketed in the United States by SmithKline Beecham under the brand name Avandia.
Crystal Wyand, a spokeswoman for the FDA’s Center for Drug Evaluation and Research, said the agency has not issued any warnings in relation to Avandia. "The agency, as with any drug, continues to monitor and review reports of adverse events associated with the drug. The agency has not changed its assessment of Avandia, nor has the agency made any decisions for a regulatory action," she said in a written statement.
Brian Jones, a spokesman for SmithKline Beecham, says the Scrip article had a "really aggressive headline" that was not substantiated in the article’s body. "There is no problem with Avandia," Jones says. "Our clinical trials show a 0.2% frequency of hepatic events, which was even lower than we expected."
Since Avandia received FDA approval May 25, more than 450,000 prescriptions have been written for the drug in the United States. Package liners for Avandia call for liver function monitoring at the start of rosiglitazone therapy and quarterly during the first year and periodic testing thereafter because of the liver toxicities associated with Rezulin (troglitazone), a drug in the same class.
"I’ve not seen anything connecting Avandia to any liver problems," says Bruce Zimmerman, MD, president of the American Diabetes Association and professor of medicine and consulting endocrinologist at Mayo Clinic in Rochester, MN.
However, Zimmerman cautions against using new drugs "willy-nilly" because clinical trials, although they are encouraging in their effectiveness in reducing insulin resistance, are by definition limited by time and numbers of patients involved. New drugs may yet yield unexpected side effects, he says.
"These medications are different from the sulfonylureas and metformin, and we should be cautious in their use until we can get a better sense of their safety, especially since these are medcations we anticipate will need to be used long term," Zimmerman says.
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