The FDA is aware of the EMA’s analyses and believes that the EMA’s conclusions "are consistent with our current understanding of the data," an FDA spokesperson said in an interview. "FDA believes that the current labeling for approved GLP-1–based therapies reflects the extent of our understanding of the safety signals at this point in time," she added, noting that the FDA’s review is ongoing as pancreatitis and pancreatic cancer data are being collected in the cardiovascular outcome trials being conducted with this class of drugs, and there is an ongoing epidemiological study.
GLP-1 receptor agonists have been associated with an increase in thyroid C-cell carcinomas in rats, but there is no evidence these drugs are associated with medullary thyroid cancer in humans, data that include an analysis of 10 studies conducted by the EMA, according to the consensus statement.
The incretin-based treatments, GLP-1 receptor agonists, and dipeptidyl peptidase–4 (DPP-4) inhibitors have been associated with some reports of acute pancreatitis, but "causal mechanisms have not been established," and "the link to pancreatic cancer is unclear," the statement said.
The incretin mimetics available in the United States include exenatide (Byetta, Bydureon), liraglutide (Victoza), sitagliptin (Januvia, Janumet, Janumet XR, Juvisync), saxagliptin (Onglyza, Kombiglyze XR), alogliptin (Nesina, Kazano, Oseni), and linagliptin (Tradjenta, Jentadueto).
Dr. Handelsman disclosed having received research grant support, consulting fees, and speaker’s honoraria from various pharmaceutical companies. The disclosures of the remaining 11 authors and task force members included having received speaker’s fees, consulting fees, and research contracts from, and/or holding shares in, various pharmaceutical companies. The consensus statement and the AACE conference that was the basis of the statement were supported by AACE. The conference was partly funded with grants from Amylin Pharmaceuticals, Bristol-Myers Squibb, AstraZeneca, Eli Lilly, Merck, Novo Nordisk, and Sanofi-Aventis US.