Earlier this month, the U.S. Food and Drug Administration (FDA) declined to approve a new class of diabetes medication until its creators, Bristol-Myers Squibb and AstraZeneca, provide more information on the drug's safety.

On the heels of lawsuits against the diabetes drugs Actos, which increased the risk of bladder cancer, and Avandia, which increased the risk of heart attack, the FDA is requiring additional data on dapagliflozin. It may even require new clinical trials to better assess the risks and benefits of the new drug.

Clinical trials for dapagliflozin showed it to be effective in reducing blood sugar by enabling patients to excrete blood sugar in their urine. However, nine cases of bladder cancer occurred in male patients and nine patients developed breast cancer while taking the new drug. The control group taking a placebo experienced one case of bladder cancer and one case of breast cancer.

In July, FDA advisors said the benefits of dapagliflozin did not outweigh the risks of bladder cancer and breast cancer. FDA reviewers also said there were possible liver risks and it was less effective in patients with kidney impairment.

It's unclear if the drug companies will undertake new clinical trials. A spokesperson for AstraZeneca said it would decide its next course of action after speaking with FDA officials.

If you have been injured by a defective drug, contact an Arizona Actos lawyer to discuss your options.

Source: Bloomberg Business Week, "Bristol, AstraZeneca Diabetes Drug Fails to Win FDA Backing," Allison Connolly and Molly Peterson, January 23, 2012.