Diabetes Drugs, Pancreatic Cancer Not Linked: Study
But FDA assessment calls for further look at injectable type-2 treatments
Also, unlike some diabetes drugs that promote harmful weight gain, GLP-1 agonists cause weight loss, while DPP-4 inhibitors are weight neutral. Weight loss often improves diabetes.
After the drugs received approval, the FDA and EMA received reports of pancreatitis (inflammation of the pancreas) and pancreatic cancer in people taking the drugs.
"There was a disproportionate reporting of these adverse events detected," said the lead author of the safety assessment, Dr. Amy Egan, deputy director for safety in the FDA's division of metabolism and endocrinology products.
However, the risks of pancreatitis and pancreatic cancer are already elevated in people with type 2 diabetes, said Egan. In addition, because they can aid weight loss, GLP-1 agonists are often prescribed to heavier people. Obesity is also a known risk factor for pancreatitis disease, Egan noted.
Because these and other factors can confound findings of an association in people taking the drugs, the FDA and EMA conducted extensive reviews of the available data from animals. The FDA reviewed 250 toxicology studies conducted in nearly 18,000 healthy animals. The EMA conducted a similar review. Neither agency found an increased risk of pancreatitis related to incretin-based drugs.
And neither agency found any drug-induced pancreatic tumors in rats and mice treated for two years (their adult life span) with the drugs.
Both agencies also reviewed data from hundreds of trials in humans and found no convincing link. Two large clinical trials are currently underway, and experts hope they will provide a more definitive answer.
So what's a person taking these medications supposed to do in the meantime?
"In June, the American Diabetes Association, the European Association for the Study of Diabetes and the International Diabetes Federation released a statement recommending that no patient should discontinue their medication without consulting their doctor first. And patients taking these medications should be informed of all the possible risks and benefits so they can make the best decision for themselves," said Ratner.
The FDA and EMA have further validated that position, Ratner said. "We need to continue to be vigilant, but as of now, there doesn't seem to be any reason to change our approach," he noted.
The FDA concluded that the current labeling for these drugs contains the necessary information and isn't recommending any labeling changes at this point.