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The U.S. Food and Drug Administration (FDA) revised the prescribing information for sitagliptin, marketed under brand names, Januvia® and Janumet® in late 2009. The revision would include information about cases of acute pancreatitis that had been reported by sitagliptin users.

FDA Warns Consumers of Possible Link to Pancreatitis

According to the FDA, some 88 sitagliptin patients reported acute pancreatitis, two of which were hemorrhagic or necrotizing pancreatitis, between Oct. 16, 2006 and Feb. 9, 2009. The FDA sought to provide consumers with a warning about the possible link to mild and severe forms of pancreatitis.

The agency also recommended that healthcare providers keep a close eye on patients taking Januvia® or Janumet®, and examine them immediately should they show any signs or symptoms related to pancreatitis.

Common symptoms include:

• Severe abdominal pain
• Pain radiating to the back
• Nausea
• Fever
• Swollen stomach, tender to the touch
• Fast heartbeat
• Headache

Complications may lead to dehydration and or low blood sugar.

The agency notes that there has not been an official link to pancreatitis among patients who have a history of the condition. No additional risk for those who have already suffered from an inflamed pancreas has been made. Januvia® and Janumet® have not been recalled. The FDA warning intends to alert consumers and their healthcare providers of the potential side effect of Januvia® and Janumet® and of its symptoms and possible complications.

Complications of Pancreatitis

Some complications can arise in patients with pancreatitis, including the following:

• Development of Diabetes
• Difficulty breathing
• Infection
• Kidney failure
• Malnutrition
• Pancreatic cancer
• Internal bleeding

The worst cases can result in death.

Compensation May be Available for Januvia® and Janumet® Patients

If you or someone you love has suffered pancreatitis and have a history of taking sitagliptin, contact a dangerous drug lawyer today to find out if you qualify to seek compensation for your losses. We are investigating lawsuits on behalf of patients who feel they have been harmed from this drug. Call today and schedule a free, no-obligation consultation with an experienced attorney.