Amid Mounting Onglyza Lawsuit Filings, FDA Gives Tentative Nod to Generic Saxagliptin

Published on July 11, 2017 by Sandy Liebhard

The U.S. Food & Drug Administration (FDA) has granted tentative approval to a generic version of saxagliptin manufactured by Glenmark Pharmaceuticals Inc, USA.

AstraZeneca currently markets the brand-name version of saxagliptin. However, the company has been named a defendant in a growing number of Onglyza lawsuit filings involving the medication’s alleged association with heart failure and other cardiac side effects.

Onglyza Side Effects & FDA Warnings

The U.S. Food & Drug Administration (FDA) approved Onglyza in 2009 to treat Type 2 diabetes. Five years later, the agency launched a review of all saxagliptin-containing drugs after interim data from a large clinical trial called SAVOR-TMI indicated that patients treated with the medication were 27% more likely to be hospitalized for heart failure compared to those who were not. Saxagliptin also appeared to be associated with a higher risk of all-cause mortality.

The following year, the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) overwhelmingly voted to recommend that the prescribing information for Onglyza and other saxagliptin-containing drugs be modified to warn of a potential heart failure risk.

The FDA announced label modifications for Onglyza and Kombglyze XR (saxagliptin and metformin) in April 2016. Patients taking these medications have been advised to contact their doctor if they develop signs and symptoms of heart failure, including:

• Unusual shortness of breath during daily activities
• Trouble breathing when lying down
• Tiredness, weakness, or fatigue
• Weight gain with swelling in the ankles, feet, legs, or stomach

Onglyza Lawsuits

In May 2017, the National Law Journal reported that up 200 product liability claims had been filed in U.S. courts on behalf of patients who suffered serious cardiac problems, including heart failure, allegedly related to treatment with Onglyza and Kombiglyze XR. The report speculated that the litigation involving saxagliptin medications could eventually grow to include thousands of similar lawsuits.

Plaintiffs involved in this litigation claim that AstraZeneca failed to warn patients and doctors about the potential for saxagliptin to cause heart failure, cardiac arrest and death. They further charge that the company launched Onglyza without conducting clinical trials to assess its cardiac impacts, even though the FDA issued a directive in 2008 calling on the developers of new diabetes drugs to demonstrate their products wouldn’t increase such risks.

The pending Onglyza lawsuits involve patients who have congestive heart failure or cardiac symptoms, while a handful were filed on behalf of patients who died after using saxagliptin. The article noted that damages in some cases could be substantial, depending on the health of each plaintiff prior to exposure.