Bristol-Myers, AstraZeneca in legal hot seat over Onglyza heart failure warning

AstraZeneca global R&D HQ
AZ and BMS didn't warn of Onglyza's heart failure risks, lawsuits allege. (AstraZeneca/Herzog & DeMeuron)

Last year, the FDA called for stronger heart-failure warnings on the label of AstraZeneca Type 2 diabetes med Onglyza. And now, AstraZeneca and former partner Bristol-Myers Squibb are being hit with 14 lawsuits related to the med’s heart-failure risks.

The suits, filed in the District of New Jersey, claim the drugmakers failed to warn users that Onglyza and related combo product Kombiglyza XR can cause cardiac arrest, congestive heart failure and death, the New Jersey Law Journal reports.

The pharma pair began marketing Onglyza in 2009 before conducting clinical trials to see whether it upped patients’ cardiac risks, the plaintiffs allege, ignoring 2008 FDA guidance that urged companies to “demonstrate that” new therapies “will not result in an unacceptable increase in cardiovascular risk.”

AstraZeneca, for its part, "is confident in the safety and efficacy of Onglyza, when used in accordance with the FDA approved label, which has been established through clinical trials. We will vigorously defend against the allegations made by the plaintiffs," a spokeswoman said in a statement.

Law firm Napoli Shkolnik, which filed the suits, told the Journal that 150 to 200 Onglyza cases are pending across the U.S., and that they could eventually tally in the thousands.

Related: AstraZeneca and Takeda DPP-4 inhibitors get another warning added to their labels

Onglyza’s heart risks most recently came into the spotlight last April, when the FDA insisted its label include a warning of increased heart-failure risk. It wasn’t the only med regulators targeted, though, with the agency also requiring Takeda to update the labels for fellow DPP-4 Nesina and combos Kazano and Oseni.

Related: No red flags in Januvia heart study means a big win for Merck

Merck’s DPP-4 giant Januvia, however, didn’t suffer the same fate, thanks to a 2015 outcomes study that put the drug in the clear. Later that year, a new analysis of the trial—dubbed TECOS—showed that even those Type 2 diabetes patients with cardiovascular disease and a history of heart failure could take the med without increasing their risk of CV complications.

Luckily for AZ and Takeda, though, Merck so far hasn’t been able to capitalize on the distinction as much as it would like. Last month, the FDA shot down the New Jersey giant’s bid to add the TECOS results to the labels of Januvia and combos Janumet and Janumet XR, which would have increased its leg up on its rivals.

DPP-4, meanwhile, isn’t the only diabetes class where AstraZeneca’s meds bear heart-related question marks. The company is currently pushing through an outcomes study that will show whether its SGLT2 entrant Farxiga can match rival Jardiance from Eli Lilly and Boehringer Ingelheim at cutting down the combined incidence of heart attack, stroke and CV-related death in high-risk patients.