Onglyza could lead to heart failure, according to a recently-issued FDA warning. The agency also asked AstraZeneca and Bristol-Myers Squibb, manufacturers of Onglyza, to turn over all of their clinical trial data for review.
In addition, the FDA asked that all medical professionals report occurrences of Onglyza side effects, heart-related or not, to the FDAMedWatch program. An advisory committee said that the Big Pharma duo behind Onglyza should amend the drug’s label to include the risk of heart failure.
The warning was precipitated by a published study found in the New England Journal of Medicine that stated using Onglyza (saxagliptin) increased “hospitalization for heart failure.” The study went on to say that it did not find that the side effects meant imminent death.
Not to say that anyone is downplaying the seriousness of the situation; rather, it’s an effort to avoid panic, while still getting the word out. The FDA’s warning even said that “at this time, we consider information from the NEJM study to be preliminary. Our analysis of the saxagliptin clinical trial data is part of a broader evaluation of all type 2 diabetes drug therapies and cardiovascular risk.” It would still be worth talking to your doctor if you’re currently taking Onglyza.
The drug is a type-2 diabetes treatment and is one of several being investigated for serious side effects, including heart failure. Onglyza was approved in 2009 and increases insulin production. Onglyza is an incretin mimetic, as is Avandia, which was recalled because several people died from heart failure connected to its use.
Others have said that Onglyza may also cause pancreatic & thyroid cancer and a host of other side effects.