Drug recall lawyers at Pintas & Mullins Law Firm report of recent developments linking popular diabetes medications Januvia, Byetta and Janumet to pancreatitis and pancreatic cancer. These are the brand-names for the generic drug Sitagliptin.
The medications are a new class of drugs that use DPP-4 inhibitors, or gliptins, to control glucose levels in the blood for those suffering from type II diabetes. They were approved by the FDA in October 2006, and for the next three years theFDA reviewed 88 cases of acute pancreatitis related to the medication. Two of these cases involved hemorrhagic or necrotizing pancreatitis, which is far more severe and potentially fatal. Approximately 58 of the 88 patients (66%) were hospitalized and at least four were admitted to the ICU. Based on these cases, the FDA is currently working with the drug manufacturers to change the prescription labeling.
The new information will include reports of acute pancreatitis, recommendations for healthcare professionals to carefully monitor patients, and an alert noting that the drug has not been studied in patients with a history of pancreatitis. Patients should pay close attention to signs and symptoms of pancreatitis, such as nausea, severe persistent abdominal pain, vomiting, and anorexia. Nearly 20 of the 88 cases of pancreatitis reported to the FDA occurred within 30 days of starting the medication, and 47 patients fully recovered after they discontinued the medication. Additionally, 45 patients had at least one other risk factor for pancreatitis development, such as obesity, high cholesterol, and high triglycerides.
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Two lawsuits in San Diego are placing blame on six different drug manufacturers for failing to warn physicians and patients of the association between the medications and pancreatic cancer. The plaintiffs are the spouses of patients who took Januvia and Byetta, developed pancreatic cancer, and ultimately died. They are suing for wrongful death. One of the cases names the manufacturers of Bydureon, Victoza, and Tradjenta, in addition to Januvia, Janumet and Byetta.
Another lawsuit was brought by the daughter of a man who also passed away after being diagnosed with pancreatic cancer. The Ohio man was first prescribed to Byetta in 2007, and died in 2011. The daughter is suing Merck & Co and Amylin Pharmaceuticals for over-promoting the medications while down-playing the adverse effects.
The medications are intended to be used in conjunction with certain lifestyle changes, such as improved diet and increased exercise, to help manage diabetes. The DPP-4 inhibitor drugs slow the digestive process and reduce blood glucose levels to regulate the amount of insulin the body produces. These medications mimic the processes of the pancreas to produce larger insulin amounts when blood sugar levels get too high.
Pancreatitis is the inflammation of the pancreas, and is known to enact the development of pancreatic cancer. The drugs are also linked to potentially fatal allergic reactions and development of immune system disorders.
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In February 2011, the Gastroenterology Journal published the results of a clinical study examining the risk for pancreatitis, pancreatic cancer, and thyroid cancer in these DPP-4 medications. The team researched the database of the previously mentioned FDA case reports, and found that the use of Sitagliptin increased the odds for pancreatitis by six times. Pancreatic cancer was also 2.7 times more common in these patients compared to those taking other diabetic medications. Thyroid cancer occurred similarly amongst both groups. The findings of this study raised significant concerns about the potential long-term effects of Sitagliptin consumption, including an increased risk of death.
Diabetes affects an estimated 23 million Americans, and 90-95% of those suffer from type II diabetes. The dangerous condition is the fifth leading cause of death by disease in the United States. Januvia attorneys are investigating this issue and are currently accepting claims. If you or someone you love was diagnosed with pancreatitis or pancreatic cancer, you may be entitled to compensation from drug manufacturers.