En Español [JANUVIA]
Januvia is a type 2 diabetes that is also available in a combination pill (known as Janumet) that contains the drug metformin. (Janumet 50/500 is 500mg of Metformin plus 50mg of Januvia.)
Januvia Pancreatic Cancer
Januvia (sitagliptin) and Janumet (sitagliptin/metformin) are the first in a new class of oral diabetes medications, called dipeptidyl peptidase-4 (DPP-4) inhibitors that improve blood sugar control in patients with type 2 diabetes. Januvia - which works by affecting different cells in the pancreas - first came on the market in late 2006. However, after that release, the FDA received dozens of reports of pancreatitis from patients who were using Januvia. For many, their symptoms were later resolved once they stopped taking the drug.
Januvia was approved by the FDA in October 2006. Between October 16, 2006 and February 9, 2009, the agency received 88 post-marketing cases of acute pancreatitis, including two cases of hemorrhagic or necrotizing pancreatitis. Sixty-six of those patients required hospitalization, and four of the patients were transferred to the intensive care unit. The FDA review of these 88 patients found that 19 patients (21 percent) of pancreatitis occurred within 30 days of starting Januvia. As well, just over half of the cases were resolved once Januvia was discontinued.
Januvia/Janumet and Pancreatic Cancer
The FDA has asked Merck to update its Januvia warning label to reflect these new dangers and include:
- Information regarding post-marketing reports of acute pancreatitis, including the severe forms, hemorrhagic or necrotizing pancreatitis.
- Recommending that healthcare professionals monitor patients carefully for the development of pancreatitis after initiation or dose increases of sitagliptin or sitagliptin/metformin, and to discontinue sitagliptin or sitagliptin/metformin if pancreatitis is suspected while using these products.
- Information noting that sitagliptin 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 while using sitagliptin or sitagliptin/metformin.
- Sitagliptin or sitagliptin/metformin should be used with caution and with appropriate monitoring in patients with a history of pancreatitis.
A more recent study (May 2009) found that Januvia could lead to a form of low-grade pancreatitis in some patients and a higher risk of pancreatic cancer in people who use the drug over a long period of time. Although Januvia has successfully lowered blood sugar in people with type 2 diabetes, health professionals are urging caution, particularly because the effect of the drug may not be evident for years. (It took more than 3 years to associate Byetta with pancreatitis and warnings have only recently been made public about Januvia, even though the FDA received adverse Januvia side effects from 2006.)
Meanwhile, a study published in 2011 in the journal Gastroenterology (07/11) found a link between the use of Januvia and an increased risk of pancreatitis and pancreatic cancer. According to researchers, patients who took Januvia had six times the increased risk of pancreatitis and 2.7 times the risk of pancreatic cancer. Other researchers, however, said the study was flawed and the drugs had no such increased risk.
Diabetes affects more than 23 million in the US alone and about 90-95 percent of those affected have type 2 diabetes. Diabetes is the fifth leading cause of death by disease in the US and costs approximately $132 billion per year in direct and indirect medical expenses. Furthermore, 85 percent of type 2 diabetes patients are overweight and 55 percent are considered obese.
Currently Januvia attorneys are investigating potential lawsuits against Merck & Co alleging product liability, negligence and failure to warn claims.
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