A Kentucky man and his wife have filed a new Onglyza lawsuit that accuses the drug’s manufacturer of failing to properly warn patients and doctors about its allege cardiovascular risks. According to the July 13th filing in the U.S. District Court, Eastern District of Kentucky, David Taylor suffered a dangerous heart attack just months after he began taking the Type 2 diabetes medication.
Onglyza (saxagliptin) is Type 2 diabetes treatment marketed by AstraZeneca. Approved in 2009, the medication generated more than $700 million in sales in 2012.
In 2014, the U.S. Food & Drug Administration (FDA) announced that it had launched an Onglyza safety review following the publication of a clinical trial known as SAVOR-TMI. The study involved more than 16,000 patients, and suggested that Onglyza was associated with a 27% increase in hospitalizations for heart failure, as well as a higher risk of all-cause mortality. In April 2015, the agency’s Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) voted 14-to-1 to recommend that new information regarding a potential association with heart failure be included the Onglyza label.
In April 2016, the FDA announced that information about a possible increased risk of heart failure would be added to the labels of Onglyza and other saxagliptin-containing medicines.
According to the new Kentucky Onglyza lawsuit, Mr. Taylor used the medication to treat Type 2 diabetes from April 2015 through June 2015. He suffered a heart attack in July 2015, which has resulted permanent injuries and adverse effects.
“Defendants acted in concert with one another in the Commonwealth of Kentucky to fraudulently convey false and misleading information concerning the safety and efficacy of Saxagliptin and Onglyza and to conceal the risks of serious adverse events, including heart failure, congestive heart failure, cardiac failure, death from heart failure and other adverse effects associated with Saxagliptin and Onglyza from the public, including Plaintiff David Taylor, his physicians, and other healthcare providers,” the lawsuit states,” the complaint states.
The lawsuit asserts counts of strict products liability, negligence, failure to warn, breaches of warranty, violations of the Kentucky consumer protection act, and loss of consortium for Mr. Taylor’s wife. The Taylors are also seeking punitive damages from AstraZeneca and other defendants.