Bristol Myers Squibb and AstraZeneca Pharmaceuticals are facing a new product liability claim recently filed by a woman from California alleging she suffered complications from side effects of Onglyza.

The claim alleges the side effects of Onglyza caused the woman to develop heart failure leading to a potentially fatal cardiovascular episode.

Plaintiff Kelley M. says the manufacturers had failed to warn her against the serious side effects of Onglyza, including potential heart failure. Like millions of other patients, Kelley says she had been prescribed Onglyza (Saxagliptin) to treat her type-2 diabetes symptoms.

Onglyza is part of the incretin mimetic drug family, which works by signaling the pancreas to make more insulin to ensure a healthy blood sugar balance. Insulin is a vital component of the body’s metabolic process, and allows the body to retrieve nutrients from food.

Without sufficient insulin amounts, the body is forced to metabolize fat instead of sugar making the blood very acidic. This can cause a number of serious complications like diabetic ketoacidosis or kidney failure, making Onglyza and other type-2 diabetes medications vital for patient treatment.

Combined with diet and exercise, Onglyza is advertised as helping patients live a normal life. With these benefits in mind, Kelley says she agreed to take Onglyza and  started the prescription in August of 2012.

According to the Onglyza lawsuit, Kelley initially responded well to the medication but also allegedly suffered serious side effects of Onglyza. During the course of her prescription, Kelley claims she developed heart failure and soon discovered that the event could have been linked to the side effects of Onglyza.

Kelley’s Onglyza prescription ended in October 2016, and she says she discovered the alleged correlation soon after then.

Onglyza Heart Failure

Onglyza was approved by the FDA in July 2009 and is part of the incretin mimetic drug family. These medications are fairly new to the drug market and came under scrutiny after the drug Avandia was recalled for increased risk of cardiac death.

In addition, a recent study, SAVOR, has indicated that patients taking certain type-2 diabetes medications could be linked to an increased rate of heart failure hospitalization.

The SAVOR study was published in the New England Journal of Medicine in 2013. Researchers analyzed 16,492 type-2 diabetes patients to provide the medical community with a complete drug safety profile of Onglyza.

According to the study, Onglyza patients were found to have faced a slightly higher rate of hospitalization for heart failure compared to other medications. Even though these findings were not considered statistically significant, further research was recommended.

In April 2015, an FDA Advisory Committee urged the agency to require AstraZeneca and Bristol Myers to include potential heart failure to the list of side effects of Onglyza.

Even though these side effects of Onglyza could potentially be fatal to patients, Bristol Myers and AstraZeneca allegedly failed to warn the general public. Kelley states she would not have agreed to take the medication if she had known that heart failure was one of the potential side effects of Onglyza.

This Onglyza Lawsuit is Case No. 5:18-cv-00449-KKC, in the U.S. District Court of Southern New York.