New Heart Failure Warnings Possible for DPP-4 Inhibitors, Onglyza and Nesina

A medical panel of the US Food and Drug Administration (FDA) has recommended the agency require new warning labels for two diabetes drugs: Onglyza manufactured by AstraZeneca and Nesina by Takeda Pharmaceuticals. According to the FDA medical panel, both drugs carry increased risks of heart failure that consumers should be aware of before using them as treatment for type 2 diabetes. The FDA is not required to follow the panel’s recommendations, but it usually takes advisory committee reports into account when issuing new regulations.

The recommendation comes from the Endocrinologic and Metabolic Drugs Advisory Committee, which conducted a thorough review of DPP – 4 inhibitors, a class of drugs used to treat diabetes that contains both Onglyza and Nesina, before making its recommendation that the FDA require manufacturers to warn of the risk of heart failure. Although the FDA has not yet acted on the recommendation, the panel’s findings suggest that consumers should be aware of risks before taking the medication.

A medical panel of the US Food and Drug Administration (FDA) has recommended the agency require new warning labels for two diabetes drugs: Onglyza manufactured by AstraZeneca and Nesina by Takeda Pharmaceuticals. According to the FDA medical panel, both drugs carry increased risks of heart failure that consumers should be aware of before using them as treatment for type 2 diabetes. The FDA is not required to follow the panel’s recommendations, but it usually takes advisory committee reports into account when issuing new regulations.

The recommendation comes from the Endocrinologic and Metabolic Drugs Advisory Committee, which conducted a thorough review of DPP – 4 inhibitors, a class of drugs used to treat diabetes that contains both Onglyza and Nesina, before making its recommendation that the FDA require manufacturers to warn of the risk of heart failure. Although the FDA has not yet acted on the recommendation, the panel’s findings suggest that consumers should be aware of risks before taking the medication.

The FDA panel commissioned two clinical trials on DPP – 4 inhibitors starting in 2008 with the goal of demonstrating that patients using diabetes medication were not exposed to unacceptable levels of cardiovascular health risks. The results of both studies, which were published in the New England Journal of Medicine, suggest that patients who use Onglyza or Nesina showed close to a 30% increase in risk of heart failure over diabetic patients who did not use the drugs. Additionally, the studies showed an increased risk of first event hospitalization and a potential increase of mortality rates as a result of heart failure episodes suffered by users of DPP – 4 inhibitors.

The panel did not determine there was enough evidence to suggest the FDA issue restrictions or a recall on Onglyza or Nesina. Instead, the panel recommended the FDA increase warning requirements and continue to investigate the connection between heart failure and DPP – 4 inhibitors to ensure risks associated with the drugs are not unacceptable.

Although the FDA has not yet acted on the panel’s recommendations for increased warnings, patients and physicians can gain insight about the potential risks of heart failure associated with Onglyza or Nesina. With the results of both clinical studies and the panel’s recommendation available to the public, doctors treating patients with type 2 diabetes have more information about the drugs, and can use that information to make better informed decisions regarding drugs used in treatment.

Attorneys can also make use of the information about the risks associated with Onglyza and Nesina. A number of lawsuits have been filed alleging that similar diabetes drugs create an increased risk of pancreatic cancer, and warnings about heart failure risks could open the door for more litigation. Plaintiffs allege that manufacturers of type 2 diabetes medications including Byetta, Januvia, Janumet, and Victoza failed to warn about risks of pancreatic cancer, and have consolidated cases from across the country into a federal court in California. Although these lawsuits allege a separate harm, additional risks associated with diabetes medication could provide information necessary to file more legal action against manufacturers.

With increased scrutiny on the safety of type 2 diabetes medication from lawsuits and the FDA advisory committee recommendation, it is clear that AstraZeneca’s Onglyza and Takeda’s Nesina are under the microscope. Patients and doctors who make use of these drugs as treatment for type 2 diabetes now have the information necessary to be aware of potentials risks of heart failure, and can learn more as additional results of the ongoing FDA investigation into the safety of DPP – 4 inhibitors come to light.