Saxagliptin under analysis for heart failure risk

The FDA has requested clinical trial data on saxagliptin (Onglyza and Kombiglyze XR) to investigate a possible increase in heart failure in patients taking the drug.

The FDA request was motivated by a manufacturer-sponsored trial of the drug (analyzed by ACP Journal Club) reporting an increased rate of hospitalization for heart failure compared to patients taking a placebo.

The manufacturer is expected to submit the data to the FDA by early March 2014, after which the agency will conduct a thorough analysis and report the findings publicly. The analysis is part of a broader evaluation of all type 2 diabetes drug therapies and cardiovascular risk, and clinicians should continue to follow the prescribing recommendations in the drug labels, the agency advised in a drug safety communication.