The Safety of Diabetes Drugs
A possible connection between one of our newest and most important classes of diabetes drugs and pancreatic cancer has frightened many of us. But people with diabetes can now breathe easier.
The United States Food and Drug Administration and its European counterpart just released their joint findings concluding that these drugs, which include Byetta, Victoza, Bydureon, and Januvia, have “no compelling evidence of an increased risk of pancreatitis or pancreatic cancer.” The full-text of this report, “Pancreatic Safety of Incretin-Based Drugs — FDA and EMA Assessment,” is available free online in one of our most prestigious medical journals, The New England Journal of Medicine.
This huge review has taken years and is crucial because the FDA and the European Medicines Agency have the primary responsibility for deciding whether Americans and Europeans can use this drugs. One sentence from the report indicates the size of their task: “Clinical safety databases reviewed by the FDA included data from more than 200 trials, involving approximately 41,000 participants…”
I’ve been writing about one of these diabetes drugs, Byetta, for the past 14 years (even before the FDA approved it in 2005), and have reported here about the agency’s concerns with pancreatitis ever since the issue surfaced in 2007. At that time I wrote in “A Byetta Pancreatitis Perspective” that the FDA had sent out an alert that it suspected a link between Byetta and pancreatitis even though 27 of the 30 reported cases involved people who had at least one other risk factor for pancreatitis.
More than one and one-half years ago the American Association of Clinical Endocrinologists reached a conclusion similar to the FDA’s recent and official findings. AACE’s “diabetes and cancer consensus statement” concluded that insufficient evidence exists to support a definitive link between these diabetes medications and cancer.
Dr. Yehuda Handelsman was the lead author of that statement. Endocrine Practice published it in its July/August 2013 issue, and it is free online here.
Yesterday I interviewed Dr. Handelsman. He is an endocrinologist in private practice and the medical director and principal investigator of the Metabolic Institute of America as well as president elect of the American College of Endocrinology and the past president of the American Association of Clinical Endocrinologists.
Dr. Handelsman carefully explained to me the important but subtle distinctions about pancreatitis and pancreatic cancer with these drugs. As a class they go by several names including “incretin-based” and “GLP-1 agonists.” Those of us who use them generally call them by their trade names, Byetta, Victoza, Bydureon, and Januvia. I took Byetta for several years with great success and in fact wrote my second book about my experience with Byetta, “Losing Weight with Your Diabetes Medication.”
The key point that Dr. Handelsman made to me is that pancreatitis can be either acute or chronic. In a few cases the incretins have been implicated with acute pancreatitis, Dr. Handelsman told me. “Once or twice a year I see a patient with mild acute pancreatitis with either a GLP-1 or DDP4 [like Januvia], and I stop the medication and it goes away.”
On the other hand, cancer is only connected with chronic pancreatitis, “which these medications have not been implicated with,” he said. “People who say ‘pancreatitis and pancreatic cancer’ in one breath are wrong.”
The AACE consensus conference that Dr. Handelsman led “could absolutely not find any evidence that any of the incretin-based therapies could cause pancreatic cancer. We found for pancreatitis to develop cancer that pancreatitis has to be chronic and has to take many years. So we believe in what the experts presented to the consensus that the incretins did not cause cancer and are glad to see that the FDA and the EMA came to similar conclusions.”
Those of us who have diabetes now have even more reason to relax and rejoice.