There have been several warnings from the U.S. Food and Drug Administration (FDA) regarding Januvia (sitagliptin), an anti-diabetes drug. There have been FDA Januvia warnings for pancreatitis (pancreas inflammation). Merck & Co. has also received an FDA warning letter for delaying a study of Januvia pancreatitis for years. If you were injured by Januvia pancreatitis, contact our Januvia lawyers today for more information about a potential lawsuit.

What You Can Do & How a Januvia Lawsuit Can Help

The Schmidt Firm, LLP is currently accepting Januvia induced injury cases in all 50 states. If you or somebody you know was injured by Januvia pancreatitis, 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.

Januvia Pancreatitis

Januvia (sitagliptin) is an anti-diabetes medication. Unfortunately, the U.S. Food and Drug Administration (FDA) has warned that it can increase the risk of causing the following types of pancreatitis:

• Acute pancreatitis: This occurs when digestive enzymes inside the pancreas somehow activate and begin to auto-digest tissues in the pancreas. The condition often causes extreme, persistent upper-abdominal pain. It usually requires hospitalization.
• Hemorrhagic pancreatitis: This occurs when inflamed pancreatic tissue breaks down and begins bleeding (hemorrhaging) into the pancreas and abdomen.
• Necrotizing pancreatitis: After pancreatic tissue breaks down, there is a risk of necrosis (tissue death).

Januvia FDA Warning for Pancreatitis

The first Januvia FDA warning was published on September 25, 2009. The Drug Safety Communication announced that Januvia was linked to many reports of pancreatitis between October 2006 and February 2009, including:

• 88 reports of Januvia pancreatitis
• 66% of the patients had to be hospitalized
• 4 patients required treatment in the ICU (Intensive Care Unit)
• 2 patients had hemorrhagic or necrotizing pancreatitis
• 21% of patients had pancreatitis within 30 days of starting Januvia
• 51% of patients had pancreatitis that may have been caused by at least one other risk factor
• 53% of patients had improvements to their symptoms after they discontinued Januvia

Furthermore, the FDA warned:

“[Januvia] has not been studied in patients with a history of pancreatitis. Therefore, it is not known whether these patients are at an increased risk for developing pancreatitis and the medication should be used with caution and with appropriate monitoring in patients with a history of pancreatitis.”

Merck Gets Januvia FDA Warning Letter for Missing Pancreatitis Study

After the 2009 FDA Januvia pancreatitis warning, Merck & Co., the drug company that manufactures Januvia, was required to conduct a three-month study of Januvia pancreatitis in rodents. In February 2012, the FDA sent Merck a Warning Letter for failing to conduct the study by the agreed-upon date of June 2011.

The FDA warning letter stated:

“This violation is concerning from a public health perspective because [the required study was] part of a written agreement between you and the FDA to conduct additional testing to further assess a signal of a serious risk of acute pancreatitis.”

FDA Recommendations for Januvia

The FDA has also made several recommendations concerning Januvia pancreatitis:

• Healthcare professionals should warn Januvia patients about the risk of pancreatitis
• Be aware of the symptoms of pancreatitis, including persistent upper-abdominal pain, nausea, vomiting, weight-loss, and more.
• If a doctor diagnoses a patient with Januvia pancreatitis, Januvia should be stopped and medical care should be given.
• Patients with symptoms of Januvia pancreatitis should report their symptoms to a doctor promptly.
• Patients should talk to a doctor before starting or stopping any diabetes medication, including Januvia.

Do I have a Januvia Lawsuit?

The Schmidt Firm, LLP is currently accepting Januvia induced injury cases in all 50 states. If you or somebody you know was injured by Januvia pancreatitis, 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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