Janumet FDA Warning Information

Adults with type-2 diabetes may be prescribed Janumet (sitagliptin / metformin) to help improve glycemic control, along with diet and exercise. This medication works by stimulating beta-cells in the pancreas to secrete more insulin. Unfortunately, the U.S. Food and Drug Administration (FDA) has cautioned that Janumet may increase the risk of pancreatitis (pancreas inflammation). Other studies have raised concern about potential risks of thyroid cancer and pancreatic cancer.

Do I Have a Texas Janumet Lawsuit? Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged. If you or a loved one was injured by Janumet, you should contact our lawyers immediately. You may be entitled to compensation by filing a Janumet lawsuit in Texas.

FDA Approval of Janumet

Janumet was approved by the FDA on March 30, 2007. Click here to read more about the FDA approval of Janumet.

Janumet contains two anti-diabetes drugs: sitagliptin and metformin. Metformin has been used to treat diabetes for decades, but sitagliptin is a new anti-diabetes medication that works by inhibiting a hormone called DPP-4 (dipeptidyl-peptidase-4), which increases production of insulin in the pancreas. This helps a diabetic person lower their blood-sugar levels.

FDA Warnings for Janumet

The FDA has published the following safety warnings for sitagliptin and Janumet:

  • September 2009: This Safety Warning announced that the FDA received 88 reports of acute pancreatitis, including 2 reports of hemorrhagic or necrotizing pancreatitis, between October 2006 and February 2009.

Studies of Janumet and FDA Adverse Event Reports

There is no long-term safety data on the risks of using sitagliptin, because it is a relatively new drug. However, studies and adverse event reports have raised serious concerns about potential side effects.

One study was published in Gastroenterology in 2011. Researchers from the University of California, Los Angeles (UCLA) analyzed adverse events in the FDA MedWatch adverse event report database. They found that sitagliptin was associated with 16 reports of pancreatic cancer and 2 reports of thyroid cancer.

The lead researcher on the study cautioned:

“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 in Texas?

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Collen’s amazing success in the courtroom and well known dedication to his clients has earned him the recognition of his peers as one of The Top Trial Lawyers in Texas.”

The Clark Firm has assembled a team of trial lawyers with more than 100 years experience, participation in over 600 jury trials and $60 million in verdicts and/or settlements. Please use the form below to contact us for a free Texas Janumet lawsuit review.