FDA Approves Drug for Diabetes
Jul. 16, 1999
WASHINGTON (AP) _ Diabetics won another treatment today that promises to fight their disease with less risk than a popular but sometimes dangerous drug.
Actos, known chemically as pioglitazone, won Food and Drug Administration approval to treat Type 2 diabetes by resensitizing patients' bodies to insulin.
It becomes diabetics' second alternative to the competing diabetes drug Rezulin, which generated huge excitement when it hit the market in 1997 because it worked differently than any previous diabetes treatment. But Rezulin also can cause fatal liver damage, prompting recent government restrictions to limit the number of diabetics who try it.
In May, the FDA approved the first drug that worked like Rezulin but with allegedly lower liver risks, SmithKline Beecham's Avandia.
Actos, made by Takeda Pharmaceuticals and marketed by Eli Lilly & Co., is the newest alternative. It will be available, by prescription, next month. No price was announced.
In studies of over 4,500 patients, there were no signs that Actos damaged patients' livers, the FDA said. However, because Actos is related to the problematic Rezulin, the FDA insisted that as a precaution Actos patients have their livers tested before starting therapy and then every two months for a year.
That's the same liver testing the FDA insists Avandia patients get, too, because that drug also is related to Rezulin.