New Onglyza Heart Failure Lawsuits Filed in Ohio, Texas

Published on May 8, 2018 by Sandy Liebhard

Plaintiffs from Ohio and Texas recently joined the nationwide litigation involving the Type 2 diabetes drug Onglyza and its alleged association with heart failure.

Plaintiffs Claim They Weren’t Warned of Onglyza Heart Risks

According to a complaint filed in the U.S. District Court, Southern District of Ohio, on April 27th, Charles Marcum took Onglyza (saxagliptin) from June 2012 to July 2016. (Case No. 2:18-cv-00407-ALM-KAJ)

Though he was diagnosed with heart failure in 2015, Mr. Marcus continued to take Onglyza, allegedly because of AstraZeneca’s and Bristol-Myers Squibb’s failure to provide doctors and patients with adequate warnings of its cardiovascular risks.

“A reasonable person who had actual knowledge of the increased risks associated with using the drugs would have concluded that Onglyza and saxagliptin should not have been marketed to or used by Decedent and his physicians,” the lawsuit states.

That same day, Alice Watts of Texas filed an Onglyza lawsuit in Dallas County Circuit Court that also accused the drug’s manufacturers of concealing the heart side effects allegedly associated with saxagliptin. (DC-18-05602)

According to her complaint, Watts took Onglyza and Kombiglyze XR (a combination of saxagliptin and metformin) at various times to treat Type 2 diabetes. She alleges that her exposure to saxagliptin resulted in serious adverse events including but not limited to, heart failure, congestive heart failure, and acute hypoxic respiratory failure.

“In addition to Defendants refusing and failing to warn of the risks of heart failure, congestive heart failure, cardiac failure and death, Defendants’ saxagliptin drugs lack any benefit sufficient to tolerate the risks posed by its use because other anti-diabetes drugs are available that do not carry the increased cardiac risks of saxagliptin,” her lawsuit charges.

Onglyza and Kombiglyze XR Litigation

Onglyza (saxagliptin) was approved by the U.S. Food & Drug Administration (FDA) in 2009. Kombiglyze XR (metformin and saxagliptin) came to market the following year.

In April 2016, the FDA ordered the manufacturers of all saxagliptin-containing medications to add new heart failure warnings to their product labels, after interim results from a major clinical trial called SAVOR-TMI suggested that patients treated with the drugs were 27% more likely to be hospitalized with heart failure. Saxagliptin also appeared to be associated with a higher risk of all-cause mortality.

Dozens of plaintiffs have since filed Onglyza and Kombiglyze XR lawsuits seeking compensation for heart failure and cardiovascular injuries allegedly related to the use of the Type 2 diabetes treatments.

Earlier this year, all federally-filed claims of this nature were consolidated before a single judge in the U.S. District Court, Eastern District of Kentucky. Nearly 100 cases are currently pending in that proceeding.


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