FDA Review: Diabetes Drug Onglyza Linked to Increase in Heart Failure
In recent years, news of the dangers of some diabetes drugs has alarmed patients and the healthcare community. Many lawsuits have already been filed with regard to complications allegedly caused by Actos, Januvia, and Janumet. Now, patients taking Onglyza may have cause for concern. A U.S. Food and Drug Administration (FDA) advisory committee has raised red flags regarding two dipeptidyl peptidase-4 inhibitors: Onglyza (saxagliptin, Bristol-Myers Squibb/AstraZeneca) and Nesina (algoliptin, Takeda Pharmaceuticals).
Warning label recommendations
A majority of the panel voted to update the labels of both of these drugs to reflect new information about safety concerns, namely, the results of cardiovascular outcome studies. Fourteen out of 15 panelists on the Endocrinologic and Metabolic Drugs Advisory Committee voted to update the label for Onglyza to warn patients of the potential for an increased risk of heart failure.
One panel member voted in favor of withdrawing the drug from the U.S. market entirely. Additionally, the panel noted that more information would be needed regarding the possibility of an increased risk of death from all causes in association with Onglyza.
In 2008, the FDA requested that manufacturers who designed and developed any new type 2 diabetes medications be able to show that these drugs are not linked to a significant increase in adverse cardiovascular events. Onglyza was one of the first drugs with a completed safety study in compliance with the FDA’s recommendations.
The FDA guidance asked that manufacturers demonstrate that a drug does not increase the risk of heart failure or any other cardiovascular condition by 30 percent or more. The completed study involved 16,492 participants with type 2 diabetes and cardiovascular disease or risks of cardiovascular disease. Of those, 1,222 patients reported major adverse cardiovascular events, providing a hazard ratio of 1.00. This is below the 30 percent threshold.
“Clearly they’ve met that mark very easily, even if there is an increase in heart failure,” said panelist Erica H Brittain of the National Institute of Allergy and Infectious Diseases.
However, the FDA panelists noted that patients taking this class of diabetes medication had a 27 percent increase in the rate of hospitalization for heart failure. They further established that there was a potential for an increased risk of death overall, regardless of cause.
“An effect on all-cause mortality really cannot be ruled out,” said Robert J Smith, MD, who is the committee chair and professor of medicine at Alpert Medical School of Brown University.
Speak with an Onglyza lawyer to learn about your legal rights
Patients with diabetes may feel as though they’re faced with a gauntlet of choices: take a medication and risk complications or refrain from medicating and risk uncontrolled blood sugar levels. At The Sanders Firm, we understand how frustrating it can be to feel like a victim and we’re dedicated to empowering diabetes patients and their families by helping them make an informed decision about whether filing an Onglyza lawsuit is right for them.
Diabetes patients and family members who believe a heart complication or other adverse event may have been caused by Onglyza or another diabetes medication can contact the national drug injury lawyers at The Sanders Firm at 888.711.2392 to schedule a free, no-obligation case review.
- Medscape, FDA Panel Backs New Safety Warnings on Two Diabetes Drugs, http://www.medscape.com/viewarticle/843179#vp_1
- Reuters, FDA panel backs safety updates for AstraZeneca, Takeda drugs, http://www.reuters.com/article/2015/04/14/us-astrazeneca-onglyza-fda-idUSKBN0N51U920150414