Reuters logo
FDA staff cautious on AstraZeneca, Bristol diabetes drug
December 10, 2013 / 12:25 PM / 4 years ago

FDA staff cautious on AstraZeneca, Bristol diabetes drug

LONDON, Dec 10 (Reuters) - U.S. Food and Drug Administration staff said on Tuesday they were wary about the benefits versus the risks of AstraZeneca and Bristol-Myers Squibb’s new diabetes drug dapagliflozin in documents posted on the agency’s website.

It was not possible to conclude with confidence that the purported cardiovascular benefit associated with using the drug outweighed “the observed imbalance in specific malignancies or potential liver toxicity risks”, they said.

The briefing documents were posted ahead of an advisory committee meeting on Thursday.

Our Standards:The Thomson Reuters Trust Principles.
0 : 0
  • narrow-browser-and-phone
  • medium-browser-and-portrait-tablet
  • landscape-tablet
  • medium-wide-browser
  • wide-browser-and-larger
  • medium-browser-and-landscape-tablet
  • medium-wide-browser-and-larger
  • above-phone
  • portrait-tablet-and-above
  • above-portrait-tablet
  • landscape-tablet-and-above
  • landscape-tablet-and-medium-wide-browser
  • portrait-tablet-and-below
  • landscape-tablet-and-below