In April 2016 the U.S. Food and Drug Administration (FDA) announced the need for stronger heart problem warnings on the diabetes drug saxagliptin, sold under the names Onglyza and Kombigleze XR. A 2015 internal study conducted by the pharmaceutical companies themselves did find an increased for hospitalization for heart failure after saxagliptin use. A previous FDA bulletin already called on diabetes drug developers to demonstrate their products do not increase cardiac risks.
Drug-makers AstraZeneca Pharmaceuticals and Bristol-Myers Squibb are now facing lawsuits in the District of New Jersey that claim that users of saxagliptin face elevated risks of heart failure as a result of using the drug. The suits allege that Onglyza and Kombigleze XR can lead to cardiac arrest, congestive heart failure and even death. It further states that the drug companies knew of these problems but failed to notify health care providers and patients.
The New Jersey Law Journal recently asked partner Hunter Shkolnik about the value of individual of cases to which he responded that it could be high “depending on how healthy the person was before.” Unfortunately all of the plaintiffs involved in the fourteen suits have congestive heart failure or cardiac symptoms, with a few cases having been brought on saxagliptin users who have died.
Hunter further explained that he anticipates that the litigation will be coordinated on both state and federal levels; there being approximately up to 200 pending saxagliptin cases nationwide. He said that this number could potentially grow well into the thousands.