This Cardiovascular Side Effect Issue Also Involves Kombygilyze XR, A Saxagliptin - Metformin Combo Diabetes Medication
(Posted by Tom Lamb at DrugInjuryWatch.com)
AstraZeneca's diabetes drugs Onglyza and Kombygilyze, both of which contain the active ingredient saxagliptin, are under scrutiny by the FDA for an apparent association with heart failure hospitalizations which was pointed out by a New England Journal of Medicine (NEJM) study.
From the February 2014 "FDA Drug Safety Communication: FDA to review heart failure risk with diabetes drug saxagliptin (marketed as Onglyza and Kombiglyze XR)" Safety Announcement:
The U.S. Food and Drug Administration (FDA) has requested clinical trial data from the manufacturer of saxagliptin to investigate a possible association between use of the type 2 diabetes drug and heart failure. Our request resulted from a study, ["Saxagliptin and Cardiovascular Outcomes in Patients with Type 2 Diabetes Mellitus", published in the October 3, 2013 NEJM edition], which reported an increased rate of hospitalization for heart failure, when the heart does not pump blood well enough, with use of saxagliptin (marketed as Onglyza and Kombiglyze XR) compared to an inactive treatment.
For some commentary and contextual information we refer you to this February 11, 2014 FiercePharma article, "FDA puts AstraZeneca's diabetes med Onglyza on review for heart safety", from which we get the following:
The FDA has stepped up its scrutiny of diabetes drugs and their heart safety, a major concern since cardiovascular risks were associated with GlaxoSmithKline's Avandia, touching off a public controversy. After the Avandia brouhaha, FDA said it would set a higher heart-safety bar for approving new diabetes drugs....
... AstraZeneca and its development partner, Bristol-Myers Squibb, are expected to submit the relevant trial data by next month. While it's reviewing that data, the FDA says doctors should continue prescribing the drug according to labeling recommendations.
Onglyza is a DPP-4 inhibitor, a class of drugs that also includes Merck's Januvia (sitagliptin), Eli Lilly and Boehringer Ingelheim's Tradjenta/Trajenta (linagliptin) and Takeda's Nesina (alogliptin). Januvia has dominated the class, but AstraZeneca has been stepping up its bid for Onglyza sales.
We will continue to monitor this emerging drug safety issue concerning heart failure in patients using Onglyza or Kombiglyze for type 2 diabetes treatment.