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Feb 11 (Reuters) - The U.S. Food and Drug Administrationsaid it will review possible heart risks associated withAstraZeneca Plc's widely-used diabetes drug saxagliptin,marketed as Onglyza and Kombiglyze XR.
The health regulator said it requested for data fromclinical trials after the New England Journal of Medicinepublished data that showed a small rise in hospitalizations forheart failure among patients using saxagliptin. ()
The data was published by NEJM in September and was based ona study supported by AstraZeneca and Bristol-Myers Squibb Co, with whom AstraZeneca co-developed the drug beforebuying all rights in a deal completed earlier this month.
That study did not find an increase in the rate of deaths orother major cardiovascular risks, including heart attacks orstrokes, in patients who received saxagliptin, the FDA said onits website on Tuesday.
The FDA said it asked for the trial data to be submitted byearly March, after which it would analyze and publicly reportthe findings.
The FDA said it considers the information in the NEJM studyto be preliminary and that healthcare professionals shouldcontinue to prescribe the drug according to the recommendationon the drug's label.
AstraZeneca's shares were up 0.8 percent at $64.93 inmorning trading on the New York Stock Exchange.
The review of the saxagliptin trial data was part of abroader evaluation of all type 2 diabetes drugs andcardiovascular risk, the FDA said.
Heart-related problems, such as ones seen withGlaxoSmithKline's Avandia pill, are a concern withdiabetes drugs, especially as diabetics also have an increasedrisk of heart troubles.
Saxagliptin is used along with diet and exercise to lowerblood sugar in adults with type 2 diabetes. It works byincreasing the amount of insulin produced by the body aftermeals, when blood sugar is high.
Type 2 diabetes is a disease in which there is a high levelof sugar in the blood as the body does not make or properly usethe insulin hormone.
