A relatively new class of drugs known as sitagliptin includes the brand name Januvia and is used in the treatment of type 2 diabetes. Januvia—along with others in the same class—has been shown in some studies to bring significant risks to patients taking the drug. Januvia blocks or inhibits DPP-4 in the body, allowing the patient’s system to better control glucose levels as well as increasing the amount of insulin produced by the pancreas when the blood sugar is high. These DPP-4 blockers can also reduce the amount of sugar produced by the liver when the body does not need the excess.
Januvia Issues Following FDA Approval
Although the drug gained FDA approval only seven years ago, Januvia issues, problems and safety concerns soon became apparent. In addition to a small number of severe allergic reactions as well as incidents of a serious skin condition known as Stevens-Johnson Syndrome, at least 88 reports of acute pancreatitis occurred in patients taking Januvia by 2009. Nineteen of those patients developed the disease within 30 days of beginning Januvia.
Januvia UCLA Study
The potential Januvia dangers were studied at a Research Center at UCLA. In this study researchers found that Januvia could create pancreatic abnormalities—established risk factors for both pancreatitis and, potentially, pancreatic cancer. It is believed that Januvia can sometimes create extremely high levels of the cells lining the pancreatic ducts, leading to those pancreatic abnormalities.
Pancreatitis cases associated with Januvia often tend to be acute—the disease develops within a relatively short time span. A UCLA clinical study which was published in the journal of Gastroenterology found that patients taking Januvia had six times the risk of developing pancreatitis within two months of beginning the drug. Pancreatitis can often lead to pancreatic cancer which is considered to be among the most deadly forms of cancer with a four percent survival rate at five years and an average rate of survival of only 18-20 months.
Januvia Safety Concerns
The FDA has expressed Januvia safety concerns because of the high number of patients who developed acute pancreatitis while taking the drug. Over half of the reporting patients who developed pancreatitis ended up being hospitalized. Acute pancreatitis can be life-threatening with typical symptoms including abdominal pain radiating to the back, abdominal pain which worsens after a meal, tenderness of the abdomen, nausea and vomiting. While the FDA and Merck have stopped just short of a recall, a warning to healthcare professionals regarding Januvia was issued by the FDA in 2009 and again in 2012.
Merck’s Alleged Failure to Warn
Many attorneys involved with Januvia lawsuits believe that Merck & Co. may have failed to warn physicians and patients about potential dangers associated with the drug. Claims against the pharmaceutical giant will likely allege product liability, negligence and failure to warn. In 2011 alone, sales of Januvia and its sister drug Janumet reached a staggering $4.7 billion dollars. Those who have developed pancreatitis, pancreatic cancer or thyroid cancer after beginning Januvia may have a claim for the injuries they have suffered.
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