Studies Suggest Pancreatic Cancer May Be Among Byetta and Januvia Side Effects

Due to increasing concerns regarding a link between incretin mimetics and pancreatic cancer, the European Medicines Agency (EMA) has conducted a review of popular drugs including Januvia, Byetta, and others used by Type II diabetes patients, to see if there was indeed a connection. Results of the EMA study failed to confirm the existence of an association between incretin mimetics and an increased incidence of pancreatic cancer.

Januvia and Byetta work to mimic the incretin hormones in Type II diabetes patients that are produced naturally by the body to stimulate insulin after eating. Along with proper diet and exercise, these drugs are used to lower patient’s blood sugar levels.

Although the EMA failed to find a Januvia and Byetta pancreatic cancer risk, other studies have revealed information to the contrary. Results of a diabetes drug study by Johns Hopkins researchers, published in the February 2013 issue of JAMA Internal Medicine, the journal of the American Medical Association, suggest very different results. The study found that patients taking Byetta, manufactured by BMS, AstraZeneca, and Eli Lily, and Januvia, manufactured by Merck, are at an increased risk for developing pancreatic cancer, compared to those taking other drugs. Researchers analyzed the medical records of 1,269 patients with Type II diabetes who filled at least one prescription for any kind of diabetes drug during a three year period. They found that 87 of the patients who developed pancreatitis were taking either Byetta or Januvia, while 58 of the patients who developed the condition were taking another type of diabetes drug.

The Institute for Safe Medicine Practices also advised that pancreatitis and pancreatic cancer are potential Byetta and Januvia side effects. A report released by the institute suggested that injectable incretin mimetics were 28 times more likely to be linked to pancreatitis. Byetta is administered twice per day by injection. The report noted 1,723 cases recorded in a single year, including 831 cases of pancreatitis and 105 cases of pancreatic cancer. Independent studies have also linked Januvia, which is ingested orally, to acute pancreatitis, which increases the risk of developing pancreatic cancer.

FDA comments on Januvia and Byetta pancreatic cancer risk

Due to the study results published in JAMA, the FDA announced it was conducting an investigation into the incretin mimetics class of drugs, including Januvia and Byetta.

The FDA has asked researchers participating in the JAMA study to share the methods used in their research with the agency, so they can investigate further. Currently, the FDA has not reached any new conclusions on the safety of incretin mimetics. A statement on their website says, “This early communication is intended only to inform the public and health care professionals that the agency intends to obtain and evaluate this new information. FDA will communicate its final conclusions and recommendations when its review is complete or when the agency has additional information to report.”

Currently, the FDA advises patients taking Januvia, Byetta, and other incretin mimetics to continue taking their medication as directed, until speaking with their doctor. The agency asks doctors and patients to report any adverse side effects including acute pancreatitis to their FDA MedWatch program.

Litigation involving Byetta and Januvia side effects

At this time, more than 50 product liability cases are pending against the makers of Januvia and Byetta, based on several allegations.

Some of the charges leveled are that the defendants:

• Failed to conduct satisfactory clinical testing on the drugs before putting them on the market
• Failed to advise the medical community of the importance of monitoring patients for initial signs of pancreatic changes
• Failed to provide patients with sufficient warnings about Januvia’s link with increased risk for serious side effects like pancreatic and thyroid cancer, and pancreatitis.

Plaintiffs have requested that Byetta and Januvia lawsuits be centralized as multidistrict litigation in the U.S. District Court for the Southern District of California, before federal Judge Anthony Battaglia.