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FDA Warnings for Janumet Side Effects

FDA Warnings for Janumet Side Effects

According to the FDA, people with type-2 diabetes who use Janumet may have an increased risk of pancreatitis (sudden inflammation in the pancreas). Since Janumet was approved in 2007, more than 88 cases of pancreatitis have been reported. Furthermore, in 2011, a study identified several cases of pancreatic cancer and thyroid cancer in the FDA MedWatch System that were linked to Janumet.

What You Can Do & How a Janumet Lawsuit Can Help

The Schmidt Firm, PLLC is currently accepting Janumet induced injury cases in all 50 states. If you or somebody you know was injured by a severe Janumet side effect, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Drug Litigation Group or call us toll-free 24 hours a day at (866) 920-0753.

FDA Approval of Janumet

The U.S. Food and Drug Administration (FDA) approved Janumet on March 30, 2007. Click here to access the complete FDA approval package for Janumet.

When Janumet was approved, it was the first anti-diabetes medication to combine metformin (an anti-diabetes drug that has been used for decades) with sitagliptin, which is a new treatment for diabetes. Sitagliptin works by inhibiting an enzyme called DPP-4 (dipeptidyl-peptidase-4), which breaks down a hormone called GLP-1 (glucagon-like peptide-1). Without DPP-4, more GLP-1 is around to stimulate the pancreas to produce more insulin. This helps improve glycemic control in diabetics with insulin-resistance.

FDA Warnings for Janumet

In September 2009, the FDA published this Safety Warning regarding the risk of acute pancreatitis. Between 2006 and 2009, the FDA received 88 reports of pancreatitis, including 2 cases involving hemorrhagic or necrotizing pancreatitis.

  • Hemorrhagic pancreatitis: This involves severe inflammation and bleeding in the pancreas
  • Necrotizing pancreatitis: Tissue death (necrosis) in the pancreas, which may become infected

Studies of Janumet and FDA Adverse Event Reports

Because sitagliptin in Janumet is relatively new, there is no long-term safety data regarding side effects that take a long time to develop (such as cancer). However, in 2011, a study published in Gastroenterology identified 2 cases of thyroid cancer and 16 cases of pancreatic cancer in patients using sitagliptin. All of the reports were submitted to the FDA MedWatch System, which is a database of voluntarily-submitted drug injury reports. Although these reports are not proof that Byetta causes cancer, they do indicate potential risk.

According to one of the researchers who published the study:

“This analysis of the FDA database does not establish that pancreatitis, pancreatic cancer and thyroid cancer are caused by GLP-1 therapy. It simply raises the level of concern that they may be, and that the appropriate prospective studies are required to rule them out.”

Do I have a Janumet Lawsuit?

The Schmidt Firm, PLLC is currently accepting Janumet injury cases in all 50 states. If you or somebody you know was injured by a severe Janumet side effect, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Drug Litigation Group or call us toll-free 24 hours a day at (866) 920-0753.

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