FDA to Review Heart Failure Risk with AstraZeneca's Diabetes Drug

Feb 13, 2014


The FDA has requested clinical trial data from AstraZeneca Plc's popular diabetes drug saxagliptin, marketed as Onglyza, to review possible associated heart risks.

The FDA request resulted from data published in the New England Journal of Medicine, which reported an increased rate of hospitalization for heart failure with use of saxagliptin, when compared to an inactive treatment.

The FDA notes that information from the NEJM study is preliminary and the study did not find increased rates of death or other major cardiovascular risks, including heart attack or stroke, in patients who received saxagliptin. The FDA recommends that patients continue to take the drug and health care professionals continue to follow the prescribing recommendations

Read the FDA press release


Join the discussion

We welcome your thoughtful comments. Please comply with our Community rules.
All comments will display your user name.

Want to participate in the discussion?

Register for free

Log in for complete access.


No one has commented on this page yet.

RSS feed for comments on this page | RSS feed for all comments