The New York Times reports that a Food and Drug Administration panel “voted 9 to 6 on Tuesday that a first-of-its-kind diabetes drug should not be approved for use because of safety concerns, including a possible increased risk of breast and bladder cancers.”
The AP notes that the drug, dapagliflozin, is a “once-a-day pill designed to help diabetics eliminate excess sugar in their urine. That differs from older drugs that decrease the amount of sugar absorbed from food and stored in the liver.” Nearly all the FDA panelists praised dapagliflozin’s “innovative approach to lowering blood glucose, but a majority said they wanted more information on a host of safety concerns, including cancer, infections and possible liver toxicity.” Dr. Erica Brittain, a biostatistician with the National Institutes of Health, who voted against the drug, said, “The level of evidence about the cancer is fairly weak, but it’s just that the uncertainty is still there.”
Medscape reported, “Across the companies’ [Bristol-Myers Squibb and AstraZeneca] 11 clinical trials, there have been nine bladder cancers in 5,478 patients on the drug compared with one case in 3,156 controls; and there have also been nine cases of breast cancer in 2,223 women on the drug compared with just one in 1,053 female controls.” Also, panelists were concerned about “one case of liver damage that was thought to be caused by dapagliflozin.” FDA reviewer Somya Dunn, MD, said, “‘It is difficult to make this estimate based off one case,’ nonetheless estimated that one in 25,000 patients exposed to dapagliflozin for at least six months would develop serious liver injury.”
From the American Association for Justice news release.