Federal Investigation into Januvia and Pancreatitis

Januvia is a new generation type 2 diabetes medication manufactured by the global healthcare leader, Merck. Lately, however, Merck’s Januvia has come under scrutiny as new evidence has prompted the Food and Drug Administration (FDA) to conduct a safety review of the medication.  The FDA recently released a statement saying that it is evaluating studies that suggest a link to increased risk of pancreatitis and pancreatic duct metaplasia in diabetic patients receiving this diabetic medication therapy.

In March, Dr. Alexander Butler and his fellow researchers at the University of California Los Angeles reported on a small study conducted on donated organs from diabetic patients who had been treated with Januvia, a medication in a class of drugs called incretin mimetics.

Dr. Butler and his colleagues compared the pancreas of patients who had received incretin therapy to those of patients who had received other therapies and non-diabetic controls. They found that the organs from the incretin treatment group had a 40% increase in pancreatic mass and a six-fold increase in beta cell mass compared to the patients who had not received incretin therapy.

In JAMA Internal Medicine, (2/25/13),  researchers at John Hopkins published a study that showed people taking incretin mimetics, such as Januvia, had double the rate of acute pancreatitis. The JAMA study found that patients hospitalized with pancreatitis were twice as likely to be taking the drug Januvia or Byetta as diabetic patients who did not have pancreatitis. This alarmed Consumer Reports so much that it issued warnings urging patients to discuss other therapies with their doctors.

In the British Medical Journal, Dr. Edwin A.M. Gale, professor of diabetes medicine at Southmead Hospital in England, commented on those data. He said that the medical community should be worried about the results of these studies because all forms of pancreatitis predispose a patient to carcinoma of the pancreas. He added that the number of reports of pancreatitis linked to the use of incretin mimetics received by the FDA has reached “astronomical proportions.”

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Patients who have been diagnosed with pancreatitis after using the diabetic Januvia may be able to file a lawsuit. To learn more about your rights and legal options, call the Phillips Law Firm today. Our experienced Januvia lawsuit lawyers have represented families across the country in their quest for justice. For a free consultation visit the Phillips Law Firm website http://www.justiceforyou.com or call 1-800-708-6000.

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