Byetta®

Tens of millions of Americans suffer from type 2 diabetes, and a significant number of them rely on prescription medications to help manage their condition.

Several new diabetes drugs have hit the market in recent years, including one called Byetta, an injectable that mimics a natural hormone called glucagon-like peptide-1 (GLP-1). This hormone increases the production of insulin and lowers blood sugar to a safe level.

However, since the U.S. Food and Drug Administration approved Byetta (generic name exenatide) in 2005, regulators have published numerous warnings, following hundreds of reports of patients suffering serious and sometimes fatal side effects, including:

• Pancreatitis
• Kidney failure
• Pancreatic cancer
• Thyroid cancer
• Severe joint pain

These side effects are problematic not just because of the purported unreasonable risk of injury, but because the manufacturer, (Amylin Pharmaceuticals, later acquired by Bristol-Myers Squibb and then AstraZeneca), failed to warn about them. Spurring the majority of Byetta injury lawsuits is the alleged causal link to pancreatic cancer.

Byetta injury attorneys in Salt Lake City with The James Esparza Law Group are committed to holding pharmaceutical companies accountable and helping patients and others affected obtain compensation for their losses. Such compensation may cover:

• Medical bills;
• Lost wages;
• Pain and suffering;
• Loss of consortium (by a spouse);
• Funeral expenses.

In some cases, punitive damages – intended to penalize a defendant drug manufacturer – may be awarded when there is evidence of gross negligence or intentional misconduct.

Diabetes is a serious condition that can result in kidney damage and blindness, and its prevalence – roughly 30 million Americans – has driven drug makers to invest in launching new “breakthrough” treatments. But problems occur when these medications are rushed to market, while the potential health risks are inadequately vetted, downplayed or concealed.

Byetta and Pancreatic Cancer

Although Byetta has proven effective in treating type 2 diabetes, the potential link between these injections and pancreatic cancer can’t be overlooked.

As noted by The Mayo Clinic, pancreatitis is the formal name for a medical condition that involves inflammation of the pancreas, the organ that produces enzymes that assist in digestion and hormones that allow the body to regulate how the body processes sugar (glucose). Pancreatitis can either be acute (occurs suddenly and lasts for several days) or it can be chronic, occurring over a span of years. If it’s a mild case, it may go away on its own. However, severe cases can result in a life-threatening condition.

It’s a relatively rare condition (50 out of every 100,000 people have it, according to The National Pancreas Foundation), with typical causes ranging from gallstones to alcoholism to genetics.

The American Cancer Society reports those with chronic pancreatitis have a higher risk of developing pancreatic cancer. The New England Journal of Medicine found pancreatitis increases the risk of pancreatic cancer by 26-fold.

Pancreatic cancer is an aggressive condition that can be resistant to treatment, which generally includes surgery, radiation, chemotherapy or some combination of these. When none of these are effective, patients are offered palliative care, which focuses on providing relief from pain and other symptoms for those with terminal illness. The American Cancer Society reports that for all stages of pancreatic cancer, the one-year relative survival rate is 20 percent and the five-year rate is 7 percent. Often, by the time the cancer is discovered, it has already spread to the point surgical removal is impossible.

Some researchers have concluded that Byetta – and other drugs in its class – may overstimulate the pancreas, resulting in an unhealthy production of pancreatic cells that could lead to cancer.

In 2007, the FDA added information to Byetta’s label indicating a possible risk of users developing pancreatitis – including fatal and serious non-fatal cases.

One study in 2011 conducted by researchers at The University of California and published in the journal Gastroenterology found patients who took Byetta over a five-year period were at a three-fold risk of developing pancreatic cancer.

Then in 2013, FDA regulators issued a Drug Safety Communication regarding academic findings that pancreas tissue samples taken from a small number of deceased patients who had been taking drugs like Byetta had inflammation and cellular changes that often precede cancer. Other incretin-mimicking drugs, like Victoza (liraglutide) and Januvia (sitagliptin) were also named as posing a possible risk. The FDA’s Byetta Medication Guide now warns that severe inflammation of the pancreas leading to serious illness and death “can happen in people who take Byetta.” Still, the FDA has stressed it has not reached any definite conclusion about whether Byetta, or other incretin-mimicking drugs, cause or contribute to the development of pancreatic cancer.

Patients are instructed to inform their doctors if they suffer from pancreatitis or gallstones prior to taking the medication.