A patient’s lawsuit recently claimed that saxagliptin side effects can include heart failure and death, possible outcomes which were allegedly not warned by the drug’s manufacturers.

Plaintiff Cyndy M. recently filed a lawsuit against Bristol-Myers Squibb, Astrazenca, and McKesson, alleging that their saxagliptin drugs, sold under brand names Onglyza and Kombiglyze XR, can cause dangerous saxagliptin side effects including heart failure and cardiac-related death.

According to her complaint, Cyndy was prescribed saxagliptin by her doctor and she took the drug as instructed for the treatment of type-2 diabetes. While using the drug, Cyndy allegedly developed serious saxagliptin side effects including heart failure and cardiovascular injury.

Cyndy alleges that her injuries were a direct result of her usage of the drug, and that she was not sufficiently warned about the possible saxagliptin side effects and risks.

“Plaintiff and the non-defendant health care providers involved could not, through the exercise of reasonable care, have discovered the risk of serious injury associated with and/or caused by Saxagliptin,” Cyndy claims. “Defendants acted with conscious and/or deliberate disregard of the foreseeable harm caused by use of their products.”

Saxagliptin drugs, sold under numerous brand names including Onglyza and Kombiglyze XR, are prescribed for the treatment of type-2 diabetes. These drugs work by manipulating the natural production of insulin to manage blood sugar levels.

However, Cyndy argues that the defendants did not properly research the long term affects of manipulating insulin production and the possible saxagliptin side effects which may result.

“Such studies are essential when developing, and then marketing, diabetic drugs to individuals already at an increased cardiovascular risk,” the saxagliptin side effects lawsuit argues.

Years after the U.S. Food and Drug Administration issued new guidance regarding cardiovascular risks in diabetes patients, the defendants allegedly initiated the SAVOR study which would asses saxagliptin side effects and cardiac risks. The results of the study reportedly showed that patients taking the drug had “a statistically significant increased risk of being hospitalized due to heart failure”.

Despite the results of the study, Cyndy says the defendants allegedly continued to not warn patients about saxagliptin side effects and the risk for heart failure. Even after the FDA reviewed the study and recommended that the manufacturers add a heart failure warning, the defendants allegedly did not.

“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,” the saxagliptin side effects lawsuit claims.

Cyndy accuses the defendants of design defect, negligence, failure to warn, and breach of warranties. The saxagliptin side effects lawsuit seeks compensatory damages, medical expenses, past and future loss of wages, consequential damages, noneconomic damages, wrongful death damages, restitution and disgorgement, punitive damages, court costs, and attorneys’ fees.

The Saxagliptin Side Effects Lawsuit is Case No. 5:18-cv-00450-KKC in the United States District Court for the Southern District of New York.