Onglyza Lawsuit Alleges Side Effects Caused Heart Failure, Death

AstraZeneca faces a wrongful death lawsuit brought by the daughter of a woman who allegedly suffered fatal heart failure due to the side effects of Onglyza, a diabetes drug that has been under recent scrutiny due to the potential heart risks. 

The complaint was filed by Rochelle Gibson on October 29, in Cook County Circuit Court. Gibson is the daughter of Lillie Ree Gibson, who allegedly died as a result of heart failure from Onglyza on October 31, 2013.

According to the lawsuit, Gibson was prescribed Onglyza in 2010, and suffered heart failure in June 2011. She was hospitalized twice before dying two years later as a result of complications associated with the condition.

Onglyza (saxagliptin) was developed jointly by AstraZeneca and Bristol-Myers Squibb, but is now owned wholly by AstraZeneca. It was approved by the FDA in July 2009, for treatment of type 2 diabetes, and the medication is part of a class of drugs known as incretin mimetics, which also includes Januvia, Janumet, Byetta, Victoza and other widely used medications.

Onglyza is a DPP-4 inhibitor, which works by mimicking the incretin hormones the body usually produces to naturally stimulate the release of insulin in response to a meal. The diabetes drug brought in more than $700 million in sales in 2012. Other DPP-4 inhibitors include Nesina and Januvia.

The FDA launched an investigation into the potential heart risks with Onglyza last year, following the publication of the SAVOR study by the New England Journal of Medicine in 2013.

In April, the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee voted 14-1 to recommend stronger warnings about the potential Onglyza heart risks, after a review of data from clinical trials suggested that users may face a higher than expected risk of hospitalization for heart failure and all-cause mortality.

The FDA’s advisory committee had several possible options, including new label warnings, limiting Onglyza’s availability, or recommending an Onglyza recall. In the end, only one committee member voted for a recall. The other 14 called for new label warnings. While the agency has not yet acted on the recommendations, the FDA usually follows the guidance of their advisory committees.

In July, Onglyza was one of several drugs that the pharmacy benefits manager Express Scripts decided not to cover in its National Preferred Formulary, the most widely used formulary in the U.S. It’s prescription drug coverage guidelines affect which drugs are insured for about 25 million Americans.

Reports and sources indicated that Express Scripts dropped Onglyza due to its health risks and because there were safer, comparably priced diabetes drugs on the market that did the same job.