Byetta Side Effects Cancer
In 2011, a team of researchers uncovered a potential link between Byetta and pancreatic cancer. Prior to the Byetta side effects cancer risk there were previous warning regarding pancreatitis. In 2007, the U.S. Food and Drug Administration issued a warning to the public regarding a connection between the type II diabetes drug Byetta (exenatide) and acute pancreatitis. Thirty cases of the disease had been identified in Byetta users during postmarketing surveillance. A second warning was issued by the FDA the following year after 6 cases of hemorrhagic or necrotizing pancreatitis were identified.
Despite these dangers, the drug remains for sale. It generates revenues in excess of a half billion dollars each year for its marketers Amylin Pharmaceuticals and Eli Lilly. However, spurred by recent FDA warnings and research demonstrating the increased risk of cancer, some patients have considered filing Byetta lawsuit claims.
The discussion that follows will describe the study that generated concern about pancreatic cancer. You’ll also learn the reason some experts have expressed reservations about the research team’s findings.
Study Highlights 3-Fold Increase In Pancreatic Cancer Risk
As implied earlier, the possibility that use of exenatide might increase the risk of acute pancreatitis has been known for years. The warnings announced by the FDA – in 2007 and 2008 – demonstrate as much. Further, chronic pancreatitis has long been considered a risk factor for pancreatic cancer. With these facts in mind, the researchers’ findings reported in the journal Gastroenterology in 2011 come as little surprise.
The researchers, led by Dr. Peter Butler at UCLA, focused on disease outcomes stemming from the use of exenatide and another diabetes medication called sitagliptin (marketed as Januvia). The team established a baseline by noting similar outcomes associated with four control drugs. They used data found in the FDA’s adverse event reporting database derived from reports submitted between 2004 and 2009 for each of the therapies.
The researchers identified a 6-fold risk of pancreatitis associated with the use of exenatide and sitagliptin, when compared to the control drugs. Additionally, with exenatide, they found a near 3-fold risk of pancreatic cancer (sitagliptin was linked to a 2.7-fold risk of the disease).
Previous studies had been done on rats to show an increased likelihood of pancreatitis. But the UCLA study was one of the first to underscore a risk of pancreatic cancer associated with Byetta therapy. Dr. Butler was quick to remark that his group’s findings should not be considered conclusive evidence that Byetta causes pancreatic cancer, thyroid cancer, or acute pancreatitis. He stated, “It is important to avoid alarmism and have people stop medicines that they may be benefiting from when the risk is not yet defined.”
Reservations Regarding Findings On Byetta Pancreas Cancer
Shortly after the UCLA study was published in Gastroenterology, its findings began to draw criticism. Some experts, such as Dr. Michael Nauck of the Diabetes Center Bad Lauterberg in Harz, Germany, suggested that relying upon data extracted from the FDA database of adverse event reports was problematic. Doing so, according to Dr. Nauck, introduced reporting bias, as patients and doctors were more likely to report events that had been previously identified.
Dr. Butler countered that while the suggestion is valid, the therapies studied by his group were the only kind of their type to cause cellular replication. To demonstrate, he pointed to earlier animal studies that had shown replication in the ducts connecting the stomach and pancreas.
Nauck also noted that far more data would be needed to substantiate disease outcomes from randomized controlled trials. Calculating the true risk of pancreatic cancer would require more patients than the number used for Butler’s research. On this note Butler agreed. He commented that his group’s research “simply raises the level of concern, and appropriate prospective studies are needed.”
Do You Have A Byetta Pancreatic Cancer Lawsuit?
Several patients who have used this drug to improve their glycemic control have developed cancer of the pancreas or acute pancreatitis. In cases for which there is no previous evidence of either condition, use of exenatide is suspected as the root cause. Given that possibility, these patients may be entitled to compensation for their injuries from the manufacturer.
If you were diagnosed with pancreatic cancer or pancreatitis after using Byetta or a loved one died, you too may be eligible to file a claim. Contact a Byetta lawsuit settlements attorney to discuss your legal options.