Diabetes Drugs under FDA Evaluation for Pancreatic Risks

Byetta lawyers at Pintas & Mullins Law Firm report that the FDA is currently reviewing unpublished studies that suggest the popular diabetes medications may be linked to pancreatitis and pancreatic cancer. The studies also suggest the drugs may be associated with a risk of kidney failure and thyroid cancer.

The type two diabetes drugs associated with these risks are considered incretin mimetics, and include such brands as Januvia, Byetta, Janumet, and Victoza. Healthcare professionals have been concerned about these incretin memtics since 2007, when the FDA first stated it was receiving a high number of reports of pancreatitis in Byetta patients. In light of these findings, the agency issued a safety alert for the medication, which they extended to include Januvia in 2009.

The drugs are intended to imitate the incretin hormone, which the body releases to stimulate insulin in the body after a meal. The medications are supposed to be injected every day, usually twice a day, and most pharmaceutical companies sell them in doses ranging from 300mcg to 600mcg. Patients inject the drugs about an hour before breakfast and/or dinner.

Between 2005 and 2008, physicians prescribed Byetta alone seven million times, and in August 2008, there were more than 250,000 Byetta prescriptions filled. This particular drug was developed by Amylin Pharmaceuticals and produced and sold by Eli Lilly. By 2008, Amylin enjoyed more than $700 million in Byetta sales, even though six deaths had already been reported in Byetta patients.

Two of those patients had either hemorrhagic pancreatitis, which inflames the pancreas and causes it to bleed, or necrotizing pancreatitis, which refers to inflammation and tissue death, wherein the pancreas is essentially destroying itself. Another two of those deaths were in patients who were morbidly obese, weighing upwards of 400 pounds and who had severe gallstones at the time of death. Pancreatitis is associated with gallstones about 80% of the time.

Amylin’s senior vice president of research and development said that, for every 3,000 Byetta patients, about one develops pancreatitis. Acute pancreatitis, if left untreated, can lead to pancreatic cysts and fluid leaks into the abdomen, which can then lead to additional long-term problems and ultimately death.

Merck, the nation’s second-largest drugmaker, manufactures Januvia, Janumet, and Juvisync. The company reported $4 billion in Januvia sales alone in 2012, which accounts for about 9% of the manufacturer’s total revenue. A study published in JAMA Internal Medicine found that patients taking these drugs had double the risk of developing pancreatitis. The study was a retrospective analysis of animals and small groups of patients, and found that pancreatitis occurred in about three to six patients out of every 1,000.

This is significantly more than the number Byetta representatives relayed. Many doctors are saying this study is forcing them to reconsider their diabetic patient’s risk factors for pancreatitis. This study, however, was a retroactive study using data from a database. The so-called gold standard for evaluating treatments involves prospective randomized controlled clinical trials, of which there are currently nine in the works for these diabetes medications. It is unclear whether it is one of these trials that is currently being evaluated by the FDA.

Other side effects for these medications include respiratory infections, stomach issues, headaches, and lactic acidosis, which is the buildup of lactic acid in the blood that is potentially fatal. The drugs may also lead to kidney problems, which could require dialysis, and have been linked to several cases of thyroid cancer. Signs of possible thyroid cancer include a lump on the lower-front neck, breathing or swallowing issues, and throat pain.

The first pancreatitis lawsuit against Byetta was filed in 2008. The defective drug lawyers at Pintas & Mullins Law Firm are currently reviewing cases involving injuries sustained from these dangerous medications. We will continue to report on Byetta and Janumet recalls and fight on behalf of our injured clients throughout the United States.

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