AstraZeneca, Bristol diabetes pill has risks - FDA

WASHINGTON, July 15 Fri Jul 15, 2011 8:43am EDT

WASHINGTON, July 15 (Reuters) - U.S. drug reviewers said a new pill from Bristol-Myers Squibb Co (BMY.N) and AstraZeneca Plc (AZN.L) was effective in treating diabetes, but posed a number of safety risks.

The pill, with the chemical name dapagliflozin, could also be less effective if patients had kidney problems, reviewers from the Food and Drug Administration said in documents released on Friday.

In clinical trials, the drug has been linked to a higher number of bladder and breast cancer. [ID:nN1E75O04E]

The reviewers also focused on liver injury, bone safety, and urinary and genital infections.

A panel of FDA advisers will review the data on dapagliflozin next Tuesday. (Reporting by Anna Yukhananov; editing by Gerald E. McCormick)

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