Makers of a new treatment for diabetes promise their medication can fight the disease with less risk than a popular but sometimes dangerous drug.
Actos, known chemically as pioglitazone, won Food and Drug Administration approval Friday for treatment of 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.
In studies of more than 4,500 patients, there were no signs that Actos damaged patients' livers, the FDA said. Because Actos is related to the problematic Rezulin, however, the FDA insisted that as a precaution Actos patients have their livers tested before starting therapy and then every two months for a year.
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.
That's the same liver testing the FDA insists Avandia patients get, too, because that drug also is related to Rezulin.
Michael Navarro is one of the millions of Americans who suffer from Type 2 diabetes. Like many patients, he often feels that the disease runs his life, reports Correspondent Sandra Maas of CBS News affiliate KFMB-TV in San Diego.
"Being a diabetic, I have to watch what I eat. I have to make sure that I get enough exercise,...get checked out regularly," Navarro says.
Left untreated, the disease can lead to blindness, amputation, kidney failure, heart attack and stroke.
There are some minimal side effects associated with Actos, including headache, muscle pain and mild respiratory problems.
Researchers at the University of California in San Diego say that taking Actos once a day helps diabetics keep their glucose levels down.
Navarro, who participated in the University of California at San Diego clinical trials, says the drug has "had a very good impact by lowering my glucose readings and making me feel very confident."