No drug is perfectly safe, and each comes with its own side effects and potential risks. Drug companies often go to great lengths to inform doctors and patients of any and all known risks, but medication development is an ongoing process, involving research, adjustments, and at times, mistakes. When questions are raised over the safety of certain products, manufacturers are generally cautious, as failure to properly investigate claims before taking action can lead to the removal or modification of drugs that are, to all extents and purposes, perfectly usable. That said, it is important that any alleged side effects be properly investigated before allowing the continued use of the products.
The FDA concurs with the EMA’s conclusions.
When concerns are raised about drug safety, the back and forth between manufacturers, regulators, and lawyers can be a complicated and long-winded procedure. This process is only just beginning for Januvia and Byetta as conflicting reports about these drugs’ potential link to pancreatitis and pancreatic cancer continue to surface.
Januvia and Byetta are part of a family of drugs known as incretin mimetics, a relatively new class of drugs used in the treatment of type 2 diabetes. Following academic research and a UCLA study, questions were raised over the drugs’ safety, specifically their potential link to pancreatitis and pancreatic cancer in patients. According to new statements by the FDA and the European Medicines Agency, however, little evidence has been found supporting incretin mimetics’ links to these diseases.
When some patients using the drugs were found to have precancerous cells, the FDA began an investigation into the drugs’ potential risks. Now, the agency is rumored to be nearing completion on its study, with a spokeswoman reporting to Pharmalive that “the FDA concurs with the EMA’s conclusions regarding the potential pancreatic effects of GLP-1 based therapies. 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 European Medicines Agency has also been unable to confirm a direct link, adding to a wave of mixed messages over the drugs and their risk.
Although these announcements are the latest in an ongoing controversy, they provides confirmation for now, at least, that officials do not consider the drugs to post a hazard to patients’ health. Whether these findings are enough to ease the qualms of researchers and patients, however, is unknown, and lawsuits alleging the drugs are unreasonably dangerous continue to be filed.