The U.S. Food and Drug Administration (FDA) has published several warning letters about the risk of pancreatitis associated with Januvia (sitagliptin), a type-2 diabetes drug developed by Merck & Co. The FDA has also sent a Warning Letter to Merck for failing to conduct required studies of Januvia pancreatitis. Our Januvia lawyers are concerned that many people may have been injured by this side effect, and we are currently reviewing potential lawsuits.
Do I Have a Texas Januvia 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 severe Januvia side effects, you should contact our lawyers immediately. You may be entitled to compensation by filing a Januvia lawsuit in Texas.
Januvia FDA Warnings for Pancreatitis
The U.S. Food and Drug Administration (FDA) has warned that Januvia (sitagliptin) has been linked to the following types of pancreatitis:
- Acute pancreatitis: This is a sudden inflammation of the pancreas that occurs when digestive enzymes in the pancreas begin auto-digesting pancreatic tissue. Hospitalization is usually necessary to control the inflammation and prevent hemorrhagic or necrotizing pancreatitis.
- Hemorrhagic pancreatitis: Bleeding (hemorrhaging) in the pancreas
- Necrotizing pancreatitis: Tissue death (necrosis) in the pancreas; high risk of bacterial infection, sepsis (blood infection), and death. Often requires surgery to remove necrotic tissue.
Januvia FDA Warning for Pancreatitis
September 25, 2009 — FDA Drug Safety Communication for Januvia pancreatitis. Between October 2006 and February 2009, the FDA received the following reports of Januvia pancreatitis:
- 88 reports of Januvia pancreatitis
- 58/88 (66%) of patients required hospitalization
- 4 patients were admitted to the Intensive Care Unit
- 2 patients were diagnosed with hemorrhagic or necrotizing pancreatitis
- 19/88 (21%) of cases occurred within 30 days of starting Januvia
- 45/88 (51%) of patients had at least one other risk factor that could cause pancreatitis
- 47/88 (53%) of patients had symptoms resolve when they stopped Januvia
According to the FDA:
“[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
In February 2012, the U.S. Food and Drug Administration (FDA) sent a Warning Letter to Merck for failing to conduct a required study of Januvia and pancreatitis. The letter stated that Merck was years late in conducting a three-month study of Januvia pancreatitis in rodents. The study was supposed to have been completed by June 2011. Merck proposed a study, but the FDA found problems with the proposal, and Merck never submitted an adequate follow-up proposal.
According to the FDA warning letter:
“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 updated the recommendations and warnings on Januvia to warn about the potential risk of pancreatitis. They have also made the following recommendations for doctors and Januvia patients:
- Be vigilant and monitor patients for symptoms of pancreatitis, such as nausea, vomiting, anorexia, and persistent severe abdominal pain that may radiate to the back.
- If a doctor suspects Januvia pancreatitis, Januvia should be discontinued and appropriate medical care should be started.
- Patients should be informed of the risk of Januvia pancreatitis. Symptoms should be promptly reported to a doctor.
- Patients should not start or stop taking any medications before talking to a knowledgeable healthcare professional.
Do I have a Januvia Lawsuit in Texas?
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