The cancer and liver toxicity risks of Bristol-Myers Squibb Co. (BMY) and AstraZeneca Plc (AZN)’s diabetes medicine may outweigh any benefit the drug has on the heart, U.S. regulators said.
The pill, potentially the second to reach the market in a new class of diabetes drugs, has cardiovascular benefit including lower blood pressure and weight loss. Food and Drug Administration staff members were wary that the heart benefits were enough to balance an increased risk of bladder cancer and indications of liver damage, according to a report posted today ahead of a Dec. 12 meeting of advisers to the agency.
