Bristol-Myers Squibb Co. and AstraZeneca Plc (AZN)’s new diabetes pill may cause breast and bladder cancer, according to U.S. regulators weighing whether to clear sales of the medicine.
While Food and Drug Administration staff said the drug is effective, they focused on safety concerns in a review of dapagliflozin released today ahead of a July 19 FDA advisory panel meeting in Silver Spring, Maryland. New York-based Bristol-Myers and AstraZeneca of London have said they expect a final decision on approval by Oct. 28.
The companies said in June that more bladder and breast cancers were seen in patients taking the new medicine instead of a placebo in studies. Regulators have increased scrutiny of diabetes pills since GlaxoSmithKline Plc (GSK)’s top-selling Avandia was tied to heart attacks in 2007 and was ultimately forced off the market in Europe and severely restricted in the U.S.
“Several unexpected safety issues identified in this clinical development program were of sufficient concern to FDA to merit discussion of their impact on the overall benefit-risk consideration of dapagliflozin,” agency reviewers said in the report.
Its been a tough year for the pharmaceutical company. Pharmaceutical giant AstraZeneca must pay 124 women a total of $250,000 to settle a sex discrimination lawsuit brought by the US Department of Labor.
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