Merck Responds to Januvia Pancreatic Cancer Concerns
By Robert J. Boumis
The same day that the U.S. Food & Drug Administration (FDA) released a Drug Safety Communication regarding precancerous changes associated with GLP-1 drugs like Januvia, Merck & Co. issued a statement insisting on the safety of Januvia.The Drug Safety Communication, issued on March 14, 2013, stated that the FDA was “evaluating unpublished new findings by a group of academic researchers that suggest an increased risk of pancreatitis, or inflammation of the pancreas, and pre-cancerous cellular changes called pancreatic duct metaplasia” associated with GLP-1 drugs as a class. The communication states that at the time of the announcement, the FDA was not ready to make a more definitive statement about potential Januvia side effects, and intended to continue monitoring until such time as the evidence became clearer.
Precancerous changes are changes at the cellular level that indicate an increased risk of cancer. Precancerous cells show deviations from their normal, typical arrangement, and begin to take on some of the characteristics of cancer cells, including abnormal shape, size and growth. These changes are associated with an increased risk of cancer and are considered a sign that tissue may become cancerous.
Merck, the manufacturer of Januvia, issued a statement on the same day the FDA issued the Drug Safety Communication. Per Merck’s press release, their Chief Medical Officer, Dr. Michael Rosenblatt, M.D., expressed confidence in the safety of the drug:
“Merck has reviewed all of the safety data on sitagliptin currently available to us and, based on that review, we find no compelling evidence establishing a causal relationship between the use of sitagliptin and pancreatic cancer. Because nothing is more important to Merck than the safety of our medicines and the people who take them, we will continue to vigorously monitor the safety of sitagliptin in close collaboration with regulatory agencies and scientific experts. Type 2 diabetes is a serious condition. As the FDA said, patients should not stop taking any medicine without speaking to their health care professional.”
Despite Merck’s assurances, lawsuits have been filed against the drug company and manufacturers of other GLP-1 diabetes drugs. These lawsuits argue that the drugs cause pancreatic and thyroid cancer. The pancreatic cancer lawsuits allege that the manufacturers were aware of these risks – or reasonably should have been aware of them, based on peer-reviewed research, post-market surveillance, and their own clinical trials. The pancreatic cancer lawsuits further allege that the manufacturers not only failed to warn the public, but may have actively concealed the risks from the public and health care communities.
If you or someone you care about suffered from pancreatic cancer after using Januvia or other GLP-1 diabetes drugs, you have almost certainly found yourself facing a trying ordeal. Since the pancreas has few pain receptors, the disease tends to go undiagnosed until the final stages, when the disease has a very poor prognosis. In fact, the majority of patients with pancreatic cancer pass away within a year of their diagnosis.
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