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According to allegations raised in a lawsuit filed by a Texas woman, the diabetes drug Onglyza caused her to suffer heart failure and acute hypoxic respiratory failure, indicating that the manufacturers knew or should have known about the risk, yet withheld information from consumers and the medical community.
The complaint (PDF) was filed by Alice Watts in Dallas County District Court in Texas on April 27, against AstraZeneca and Bristol Myers Squibb.
Watts indicates that at various times for treatment of her type 2 diabetes she was prescribed Onglyza, as well as Kombiglyze XR, which combines Onglyza with the older diabetes drug metformin. However, she indicates that she was never adequately warned that the drugs may cause heart failure, congestive heart failure and other serious health conditions, including death.
Although Onglyza and Kombiglyze XR have been marketed as a safe and effective diabetes drug, concerns have emerged in recent years about the potential heart risks, leading the FDA to add new information about the heart risks to the drug label in 2016. However, the complaint indicates that as far back as 2008, a year before Onglyza was approved, clinical trials showed that users of the drug had a statistically significant increased risk of being hospitalized for heart failure. Despite that, the manufacturers released it anyway, knowing it was no better than drugs already on the market.
“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,” Watts’ lawsuit states. “Defendants, with knowledge of the true relationship between use of Saxagliptin and heart failure, congestive heart failure, cardiac failure, and death related to those events, promoted and continue to promote Saxagliptin and a safe effective treatment for type 2 diabetes mellitus.”
An investigation into the potential heart risks with Onglyza was first launched by the FDA in 2014, following the publication of a study, known as “SAVOR”, in the New England Journal of Medicine in 2013.
In April 2015, the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee voted 14-1 to recommend stronger warnings about the potential Onglyza heart side effects, 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 review looked at two large clinical trials involving patients with heart disease. In both trials, patients given drugs containing saxagliptin or alogliptin were at a higher risk of being hospitalized for heart failure than those given a placebo.
Watts’ claim joins a growing number of similar Onglyza lawsuits filed by individuals nationwide who say they developed heart failure or other health problems due to the lack of adequate warnings on the diabetes drug.
While Watt’s lawsuit was filed at the state level in Texas, most have been filed in federal courts. Earlier this year, the U.S. Judicial Panel on Multidistrict Litigation consolidated all federal Onglyza cases in the U.S. District Court for the Eastern District of Kentucky, as part of a federal MDL, or multidistrict litigation, where they will undergo coordinated pretrial proceedings under District Judge Karen K. Caldwell.