Onglyza Heart Failure Warning leads to Lawsuits

In 2016, the FDA called for stronger heart-failure warnings on the Onglyza label of AstraZeneca’s Type 2 diabetes drug. Since then, AstraZeneca and Bristol-Myers Squibb (AZ’s former partner) have been hit with 14 lawsuits over Onglyza’s heart-failure risks.

Filed in the District of New Jersey, the lawsuits claim the drugmakers failed to warn users that Onglyza and a related combination product called Kombiglyza XR can cause cardiac arrest, congestive heart failure and death.

The New Jersey Law Journal reports plaintiffs charge that the Big Pharma duo began marketing Onglyza in 2009 before conducting clinical trials to see whether the drug increased users’ cardiac risks. Plaintiffs say the two ignored 2008 FDA guidance that urged drug companies to “demonstrate that” new therapies “will not result in an unacceptable increase in cardiovascular risk.”

An AstraZeneca spokeswoman said in a statement that the company “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.”

Some 150 to 200 Onglyza cases are pending so far across the U.S., but that number could eventually reach the thousands.

Onglyza Heart Failure Warning leads to Lawsuits
Onglyza’s heart risks most recently made the news in April 2016 when the FDA insisted the drug’s label include a warning of increased heart-failure risk. It wasn’t the only drug that regulators targeted, however. The FDA also required Takeda to update the labels for fellow DPP-4 Nesina and combinations Kazano and Oseni.

Januvia Outcomes Study for Merck
Merck’s DPP-4 drug Januvia did not suffer the same fate as Onglyza. A 2015 outcomes study seemed to exonerate Januvia. Later in 2015, a new analysis of the trial called TECOS – showed that even Type 2 diabetes patients with cardiovascular disease and a history of heart failure could take Januvia without increasing their risk of CV complications.

In April 2017, however, the FDA shot down Merck’s attempt to add the TECOS results to the labels of Januvia and combination drugs Janumet and Janumet XR.

DPP-4 is not the only diabetes class where AstraZeneca’s drugs face heart-related questions. The company is now running an outcomes study designed to show whether its SGLT2 drug Farxiga can match rival Jardiance (from Eli Lilly and Boehringer Ingelheim) at cutting the combined incidence of heart attack, stroke, and cardio-vascular-related death in high-risk patients.

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