GlaxoSmithKline Plc and Eli Lilly & Co have added warnings about heart and liver risks to the labels of their diabetes drugs, which are similar to a medication withdrawn from the market in 2000 because of links to fatal liver damage.
The US Food and Drug Administration today posted information about heart and liver risks in Glaxo's Avandia and Lilly's Actos, although warnings had been added to the labels earlier. The FDA posted a summary of risks associated with the medicines on its Medwatch site to inform doctors and the public.
Doctors have been watching for signs of liver damage in patients on Avandia and Actos since their 1999 US introduction because they work the same way as did the withdrawn Rezulin diabetes medicine. Warner-Lambert Co, now a unit of Pfizer Inc, yanked the drug from the market in 2000 because it caused liver damage and deaths.
"We have just started getting calls about Avandia," said Steve Sheller, a Philadelphia lawyer with more than 100 Rezulin cases. "Clients are reporting they are suffering the same problems as the folks who used Rezulin. We're going to look into it."
Avandia had sales of US$280 million in the quarter ending March 30, a 28 percent jump over the comparable quarter a year ago, according to Glaxo. Lilly doesn't break down Actos sales, but said it was in a category of products that grew last quarter.
Some diabetes sufferers taking Avandia had three times the upper limit of an enzyme linked to liver failure, wrote David Stout, president of US drugs for Glaxo in a September 2001 letter to doctors. The FDA posted it Friday in its Web site.
"Very rarely, these reports have involved hepatic failure with and without fatal outcome, although causality has not been established,"Stout wrote.
Regulators took GlaxoSmithKline officials to task for promoting the drug without revealing the risks at a recent medical conference, Stout wrote.
Actos and Avandia cause bloating, which can spur or exacerbate heart failure. At the FDA's urging, the companies sent letters urging doctors to be on the lookout for symptoms such as rapid weight gain or shortness of breath in patients taking the medications.
Both drugs will also carry new warnings on their labels advising patients with severe heart disease not to take them because of their link to fluid retention and heart failure.
Lilly markets Actos with Japan's Takeda Chemical Industries.
The FDA cited human trials comparing use of the drugs against patients taking a dummy pill. Patients taking Avandia and Actos were more likely to suffer heart failure.
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