FDA

Summary Box: FDA won't OK diabetes drug for now

AP News
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Posted: Jan 19, 2012 4:49 PM
Summary Box: FDA won't OK diabetes drug for now

SHOT DOWN: U.S. regulators say that without more data and possibly more patient studies, they can't approve an experimental diabetes pill being developed by Bristol-Myers Squibb and AstraZeneca.

SAFETY CONCERNS: Government advisers last summer said dapagliflozin should not be approved because of risk of breast and bladder cancer, infections and possibly liver damage. The companies say they're committed to the drug.

RIPPLE EFFECT?: Several other companies are testing similar compounds, which likely will be scrutinized to see if they have the same risks.