AstraZeneca and Bristol-Meyers Squibb, the joint developers of Onglyza, have been told by a Food and Drug Administration panel to add stronger warnings about the diabetes drug’s potential to cause heart failure.

This recommendation comes after a review of clinical trials suggesting that those who use Onglyza to combat diabetes are at higher risk of heart failure hospitalization than others, as well as at a higher risk of mortality from all causes.

Onglyza (saxagliptin) was approved in July 2009 for the treatment of type 2 diabetes. This drug is part of a class of drugs called incretin mimetics, and is accompanied by similar, widely used drugs including Januvia, Janumet, Byetta, Victoza, and others. These kinds of drugs work by mimicking the body’s natural incretin hormones, used to stimulate the release of insulin in the pancreas after a meal, helping to regulate blood sugar levels.

The FDA’s Endocrinologic and Metabolic Drugs Advisory committee reviewed data from clinical trials in April which suggested Onglyza users may face a higher risk of hospitalization for heart failure than non-users. The committee found that this was a significant enough risk that it required action on the part of the manufacturer to keep consumers safe and informed.

After reviewing this data, the FDA committee voted by a vast majority (14-1) to recommend that the manufacturer add stronger warnings about potential Onglyza heart risks.

The FDA reviewed a large-scale clinical trial called SAVOR, which indicated that there may be an increased risk of heart failure hospitalization of up to 27% for those using Onglyza. The same reviewers found an indication in this study of increases in both cardiovascular death as well as death from all causes for users of Onglyza when compared to non-users.

Because of these factors, the committee found the drug’s potential risk necessitated some kind of warning to consumers as well as the medical community.

The FDA has not yet officially announced its recommendation that AstraZeneca add stronger warnings of potential risk of heart failure to the labeling. The one FDA committee member who voted against stronger label warnings advocated, not for inaction, but instead for a complete recall of Onglyza.

However, the drug’s manufacturer recently presented data to the American Diabetes Association (ADA) that suggests there is no increased risk of hospitalization from heart failure while using Onglyza compared to other, similar diabetes drugs. The manufacturer claims that Onglyza causes less of a heart failure risk than other drugs of its kind. Review of this data has not yet been published for peer review.

If you or someone you know has suffered from heart failure after using Onglyza, you may be able to take legal action.