FDA Finds No Pancreatic Cancer Risk in Byetta, Januvia

Federal drug regulators in the U.S. are echoing the recent findings of European reviewers, stating that they have been unable to confirm an increased risk of pancreatic cancer linked to side effects of Byetta, Januvia, Janumet, Victoza and other related diabetes drugs.  

The FDA has completed its review into the pancreatic safety of a new class of medications, known as incretin mimetics, and is preparing to report that it has found no conclusive connection between the medications and pancreatic cancer.

The official findings have not yet been published, but appear likely to mirror those of the European Medicines Agency (EMA), which released a statement late last week clearing the diabetes drugs of a cancer risk.

A number of studies have previously tied Januvia, Byetta and similar drugs to an increased risk of acute pancreatitis, which experts have suggested may lead some users to ultimately develop pancreatic cancer. Several consumer and medical groups have raised concerns about the potential risk of pancreatic cancer and the lack of research into this potential side effect by the drug makers.

Safety investigations were launched earlier this year by the FDA and EMA, after an independent study found evidence of precancerous cells in the pancreas of users of the drugs. The recent findings of the FDA were based on data available at this time, and could change with future medical studies or findings.

In the August 2013 issue of Public Citizen’s Worst Pills, Best Pills Newsletter (subscription required), the prominent consumer group notes that the risk of pancreatitis associated with Januvia, Byetta, Victoza and other incretin mimetics has been acknowledged by the manufacturers, resulting in new label warnings. Chronic pancreatitis is a known risk factor for pancreatic cancer, and Public Citizen indicates that it is maintaining the drugs on its “Do Not Use” list and continuing efforts to have the FDA recall Victoza from the market due to known safety concerns and limited benefits over other available treatments.

Diabetes Drug Concerns

Incretin mimetics are a relatively new class of diabetes treatments, which work by mimicking the incretin hormones that the body usually produces to naturally stimulate the release of insulin in response to a meal.

Byetta (exenatide) was the first member of this class approved by the FDA, introduced by Amylin Pharmaceuticals and Eli Lilly in 2005 as a twice daily injection. Januvia was introduced by Merck the following year as an oral medication, and a combination pill containing Januvia and metformin was introduced in 2007, under the brand name Janumet. Victoza (liraglutide) was introduced by Novo Nordisk in 2010 as a daily injection.

The medications have quickly grown to become some of the top selling drugs for treatment of type 2 diabetes worldwide, generating billions in annual sales. Januvia and Janumet are among the best selling medications for the global pharmaceutical company Merck, generating over $4 billion in sales last year. Victoza sales were about $1.8 billion last year for Novo Nordisk and Byetta earned a reported $149 million for Amylin Pharmaceuticals last year.

It is unclear how the FDA’s findings will affect the increasing concerns in the medical community. A number of individuals diagnosed with pancreatic cancer have filed product liability lawsuits in courts throughout the country. The complaints allege that the drug makers failed to adequately research the medications or warn about the potential risk of pancreatic cancer and the importance of monitoring the pancreas for changes during treatment.

Last week, a panel of federal judges heard oral arguments on a motion to centralize and consolidate all Byetta lawsuits, Januvia lawsuits, Janumet lawsuits and Victoza lawsuits filed in U.S. District Courts nationwide. While there are currently only about 50 complaints filed in the federal court system, estimates previously suggested that hundreds, if not thousands, of cases may ultimately be brought in the coming weeks and months.