Onglyza, a diabetes drug, should carry added label warnings about the risks of heart failure and death, according to an FDA panel of experts.
The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee voted 14-1 in April 2015 to recommend label warnings for Onglyza be updated to include heart failure and death. The committee had reviewed data from clinical trials suggesting users may face a higher than expected risk of hospitalization for heart failure and all-cause mortality. FDA has not yet acted on its panel’s recommendations.
Developed in tandem by AstraZeneca and Bristol-Myers Squibb, Onglyzais (saxagliptin) is now owned solely by AstraZeneca. The type 2 diabetes drug was approved by FDA in July 2009. Onglyza is part of a class of drugs known as incretin mimetics. This class includes Januvia, Janumet, Byetta, Victoza and other popular diabetes drugs; but the only drugs being reviewed contain the active ingredient saxagliptin.
At issue is data collected from a clinical trial known as SAVOR, which involved 16,492 subjects with type 2 diabetes, some of whom were given Onglyza, and some of whom were given a placebo.
An AstraZeneca press release on April 14 said the company will conduct its own interview to better understand the SAVOR results. FDA reviewers said SAVOR revealed a 27% increased risk of heart failure hospitalization linked to side effects of Onglyza. Reviewers also found increases in cardiovascular death and death from all causes.
The FDA’s advisory committee can choose from several options. It could issue new label warnings, limit Onglyza’s availability, or push for an Onglyza recall. One committee member voted for a recall; 14 wanted new label warnings.
The panel’s recommendations are not binding on the FDA; however, the agency usually weighs advisory committee recommendations heavily before making a final ruling.
Some panelists felt the health risks may be a class effect, which would mean labels for Januvia and Nesina would also need updating.
Onglyza Pancreatic Cancer Concerns
Onglyza is a DPP-4 inhibitor, which is part of a class of drugs known as incretin mimetics, which works by mimicking the incretin hormones the body usually produces to naturally stimulate the release of insulin in response to a meal. The diabetes drug brought in more than $700 million in sales in 2012. Other DPP-4 inhibitors include Nesina and Januvia.
FDA investigates Onglyza Heart Risks
The FDA launched an investigation into the potential heart risks with Onglyza last year, following the publication of the SAVOR study by the New England Journal of Medicine in 2013.
In addition to the potential risk of heart failure, studies have suggested that users may face a risk of pancreatic cancer from Onglyza and other incretin mimetic diabetes drugs.
Several Byetta lawsuits, as well as Januvia, Janumet and Victoza lawsuits are pending in courts throughout the country; all these dockets involve incretin mimetic diabetes drugs. The lawsuits all allege that makers of those medications failed to properly warn users about the increased risk of pancreatic cancer.
Incretin Mimetic MDL set in California
The incretin mimetic litigation pending throughout the country’s federal court system has been consolidated as part of an MDL, or Multidistrict Litigation court, centralized before U.S. District Judge Anthony J. Battalglia in the Southern District of California. The MDL is established to reduce duplication of discovery, as well as to avoid conflicting pretrial rulings from different judges. The MDL is also meant to serve the convenience of all involved parties, including expert witnesses and the courts.
Free Legal Consultation
If you or someone you love took Onglyza and suffered heart problems or pancreatic cancer, contact an experienced Onglyza lawyer at Matthews & Associates for a free legal consultation. regarding a potential Onglyza Lawsuit.