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Januvia FDA Warnings

Januvia FDA Warnings

There have been several warnings from the FDA regarding side effects of Januvia, including dozens of cases of pancreatitis (pancreas inflammation), hemorrhagic and necrotizing pancreatitis, and pre-cancerous growths that may indicate a risk of pancreatic cancer.

What You Can Do & How We Can Help

The Schmidt Firm, PLLC is currently accepting Januvia induced injury cases in all 50 states. If you or somebody you know was diagnosed with pancreatic cancer, 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 Warning: Disabling Joint Pain

In August 2015, the FDA issued a Safety Communication to warn about the risk of severe, disabling joint pain from Januvia. Between October 2006 and December 2013, the agency received 28 reports of Januvia patients who were diagnosed with severe joint pain. Many of the patients experienced pain that was so severe they were disabled and/or had to be hospitalized. In most cases, symptoms appeared within 1 month of starting Januvia and resolved after the medication was discontinued.

FDA Warning: Pancreatic Cancer

In March 2013, the FDA issued a Safety Communication and began investigating the risk of pancreatic cancer from Januvia. The agency was concerned about a study published in Diabetes linking Januvia with pre-cancerous pancreatic growths.

Researchers autopsied eight pancreases, including 7 from patients who used Januvia for at least one year. On average, the pancreases were 40% larger than normal due to exocrine cell proliferation (95% of pancreatic cancers start in exocrine cells). Many of the cells were “eccentrically shaped” and three pancreases had pre-cancerous growths (microadenomas and a neuroendocrine tumor) that could become malignant.

FDA Warning: Pancreatitis

In March 2013, the FDA also warned about a study published in JAMA Internal Medicine linking the use of Januvia with a doubled increased risk of pancreatitis.

However, the first FDA warning for Januvia was published in September 2009. The FDA announced that Januvia was linked to 88 reports of pancreatitis between October 2006 and February 2009.

Two of the victims developed hemorrhagic or necrotizing pancreatitis. Two-thirds of the patients had to be hospitalized. About one in five patients developed pancreatitis within 30 days of starting Januvia.

Types of Pancreatitis Linked to Januvia

  • Acute pancreatitis: Inflammation in the pancreases activates digestive enzymes inside the pancreas and damages tissues. The condition often causes extreme, persistent upper-abdominal pain and 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). The necrotic tissue is likely to become infected and typically must be removed surgically.

FDA Warning Letter: Missing Pancreatitis Study

In 2009, shortly after the FDA warned about the risk of pancreatitis from Januvia, the agency asked Merck & Co. to conduct a three-month study of 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. According to the FDA:

“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

  • 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 pancreatitis, Januvia should be stopped and medical care should be given.
  • Patients with symptoms of 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, PLLC is currently accepting Januvia induced injury cases in all 50 states. If you or somebody you know was diagnosed with pancreatic cancer, 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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