FDA Investigates Potential Link Between Januvia and Pancreatic Cancer

On March 14, 2013, the FDA released a drug safety communication stating that it is evaluating new findings suggesting a link between type II diabetes drugs like Januvia and pancreatic cancer. The class of drugs under investigation is called incretin memetics, and includes Januvia, Byetta, Onglyza, Nesina, Tradjenta, and more. The drugs work by mimicking hormones in the body that typically stimulate the release of insulin, helping to lower blood sugar levels in those with type II diabetes.

The FDA has not reached any new conclusions about safety risks with incretin mimetic drugs, the agency stated. 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 Issues First Warning in 2009

Januvia (sitagliptin) received FDA approval in 2006 for the treatment of type II diabetes. Manufactured by Merck & Co., the drug has since been linked to an increased risk of pancreatic cancer.

On September 25, 2009, just three years after it appeared on the market, Januvia was linked with pancreatic complications when the FDA notified the public that it was requiring new warning labels for the medication. Between October 16, 2006, and February 9, 2009, the agency received 88 reports of acute pancreatitis (inflammation of the pancreas) in patients using Januvia. About a fifth of these occurred within 30 days of starting the prescription.

The American Cancer Society states that in addition to cigarette smoking, obesity, and diabetes, chronic pancreatitis is linked with an increased risk of pancreatic cancer.

Studies Link Drug with Increased Risk of Cancer

A study published in Gastroenterology in 2011 found that compared to other treatments, patients taking Januvia or Byetta were at a sixfold increased risk of pancreatitis. Those taking Byetta had a 2.9-fold increased risk of reporting pancreatic cancer, and those taking Januvia a 2.7-fold increased risk.

A second study published in February 2013 in the JAMA Internal Medicine journal found that patients taking Januvia or Byetta were twice as likely as those who took other drugs to end up in the hospital with pancreatitis. Researchers compared over 1,200 patients with diabetes who were hospitalized with pancreatitis to a control group that was not, and found that 87 patients in the pancreatitis group had taken Januvia or Byetta compared to 58 in the control group.

Scientists Urge More Caution

On June 10, 2013, the British Medical Journal published a feature article noting that the issue of pancreatitis and pancreatic cancer associated with incretin mimetic therapies for type II diabetes has been downplayed by the pharmaceutical industry. The article also asserts that the FDA has not acted as aggressively as they should have regarding the safety concerns. Over the years, the author writes, drug assessors have become increasingly concerned that the incretin drugs have the potential for unwanted proliferative effects.

Meanwhile, though Januvia brought in $4 billion in sales in 2012, Merck is now facing a number of lawsuits involving the drug and pancreatic complications. A motion has been filed to consolidate all federal Byetta, Victoza, Januvia, and Janumet lawsuits into one court to form a multi-district litigation. California has already grouped a number of cases together into one court for pre-trial discovery.