AstraZeneca’s popular diabetes drug, Onglyza, has been linked with an increased risk of heart failure, according to a review of data conducted by the U.S. Food and Drug Administration.

Onglyza (or saxagliptin) is an incretin mimetic medication intended to treat type 2 diabetes. Incretin mimetics stimulate the release of insulin, which helps to regulate a patients’ blood sugar level.

In April, the FDA held an advisory panel in order to discuss the safety and efficacy of Onglyza, as well as a similar drug from Takeda Pharmaceuticals known as Nesina.

Onglyza and Heart Failure Risk

Onglyza has been connected with an elevated risk of heart failure and other Onglyza side effects for some time since its introduction to the market in 2009. The foremost study referenced for this link is known as the SAVOR study.

The SAVOR study was a trial of over 16,000 patients who took Onglyza, who were shown to have an increased risk of heart failure hospitalization than those who did not take Onglyza.

While the FDA found that the heart failure risk discovered in the SAVOR trial is a valid concern, the federal agency also linked Onglyza to an increase risk of fatality from all causes. According to the review, Onglyza is linked to “a significantly increased risk of all-cause mortality.”

In many cases, the causes of death from Onglyza patients were “multifactorial,” meaning that there may have been multiple factors that contributed to a patient’s likelihood of death. Some of the patients involved in the study may have already been experiencing serious medical problems prior to death.

The FDA is reportedly “not reassured” by the increased risk, and does “not necessarily view this pattern of variable causes as evidence the mortality signal is due to chance.”

There is currently a large trial being conducted on Merck’s Januvia drug, which is a leading DPP-4 inhibitor drug, and brings in about $4 billion a year. This trial will help to determine if the increased risk of death is linked to the entire class of drugs similar to Onglyza or just to individual drugs. The results of this trial are expected in June, and the medical community is anxiously waiting.

Wall Street is also waiting for the results of the trial, considering the kind of money that these drugs bring in to the industry.

According to Leerink analyst Seamus Fernandez, the FDA’s concerns that Onglyza and other similar drugs may be linked with all-cause mortality may have a huge effect on Onglyza sales. Fernandez estimates that, depending on how the trial goes, this could lead to up to a 50 percent cut of his $1.8 billion estimate for Onglyza sales.

If you or someone you know has suffered from heart failure or other serious Onglyza side effects, you may be able to take legal action. Filing an Onglyza lawsuit will not fix the damage, but it can help to alleviate the physical, emotional, and financial losses experienced as a result of using the drug.