Diabetes Drugs Pancreatic Cancer Risk Not Backed By Existing Evidence: FDA

In yet another boost to several large drugmakers, the FDA has decided that there is no evidence that to confirm recent concerns that a widely used group of diabetes drugs called GLP-1 inhibitors is linked to pancreatic cancer, an FDA spokeswoman says. The decision comes several days after the European Medicines Agency reached the same conclusion (here is the EMA statement). “The FDA concurs with the EMA’s conclusions regarding the potential pancreatic effects of GLP-1 based therapies,” the FDA spokeswoman writes us. “The agency 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. 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.” The review took place in response to a ruckus caused by a study published in Diabetes four months ago that found, in humans, the drugs caused “marked” cell proliferation and damage, and displayed a potential for eventually transforming into cancer. The researchers examined the pancreas of 20 deceased human organ donors with type 2 diabetes (here is the abstract). The drugs, which mimic a hormone called GLP-1 to stimulate natural insulin production, include Merck’s Januvia (MRK), which is the biggest seller in this group; Onglyza, which is sold by Bristol-Myers Squibb (BMY) and AstraZeneca (AZN); Byetta, which is also ...
Source: Pharmalot - Category: Pharma Commentators Authors: Source Type: blogs