Januvia, Byetta, Other Diabetes Drugs Focus of Controversy

Januvia_DiabetesSome popular and money making diabetes drugs are at the center of a conflict over disturbing research findings.

Although Dr. Peter C. Butler declined to test its then-new diabetes medication, Januvia, he ultimately relented and, in 2008, observed that the drug causes some pancreatic changes that are precursors to pancreatic cancer, according to a The New York Times  report. Januvia is marketed by Merck & Co.

The findings, according to The Times, might threaten the entire drug class, which brings in sales of more than $9 billion each year and which are used by hundreds of thousands of people diagnosed with Type 2 diabetes. “I knew some stuff that I thought was a worry and I was obliged to pursue it,” Dr. Butler, the chairman of endocrinology at the University of California, Los Angeles, told the Times.

Incretin mimetic drugs include Byetta and Bydureon (exenatide); Victoza (liraglutide); Januvia, Janumet, Janumet XR, and Juvisync (sitagliptin); Onglyza and Kombiglyze XR (saxagliptin); Nesina, Kazano, and Oseni (alogliptin); and Tradjenta and Jentadueto (linagliptin). These drugs increase certain natural substances that lower raised blood sugar levels. People with Type 2 diabetes typically have abnormally low insulin levels or their bodies have difficulties utilizing insulin efficiently.

Incretin mimetic drugs imitate the body’s incretin hormones. These hormones are meant to stimulate insulin release following consumption of meals and are typically used in collaboration with diet and exercise to lower blood sugar in adults diagnosed with Type 2 diabetes. In 2009, the U.S. Food and Drug Administration (FDA) required a label update on these drugs warning of the risk of acute pancreatitis, a painful, potentially fatal disorder and a known risk factor for pancreatic cancer.

Pancreatitis is an inflammation of the pancreas that is not only linked to cancer and kidney failure, when the disorder becomes chronic, it is painful and potentially fatal. The serious side effects linked to these Type 2 diabetes drugs include low blood sugar; anaphylaxis and other allergic reactions, such as hives, rash, swelling of the face, lips, tongue, and/or throat; diseases of the pancreas such as acute, necrotizing, or hemorrhagic pancreatitis; pancreatic cancer; thyroid cancer; vomiting and nausea; anorexia; persistent, severe abdominal pain, sometimes radiating to the back; and death.

Based on Dr. Butler’s study, the FDA and the European Medicines Agency (EMA) began investigations on the drugs. Also, more than 100 lawsuits representing 575 plaintiffs nationwide allege injury—typically pancreatitis—due to Byetta, according Bristol-Myers’ latest quarterly regulatory filing; 43 lawsuits claim that Januvia caused pancreatic cancer, according to Merck, wrote The Times.

Dr. Butler noted that after his group presented its findings to Merck that, “I never heard from them again,” except when Merck attorneys asked when the study results would be published, The Times said. Dr. Butler also pointed out that the studies conducted by drug firms seeking FDA approval for these medications, used healthy, young animals that would not likely develop pancreatic cancer. This is significant said Dr. Butler because these drugs increase levels of glucagonlike peptide-1, a hormone that might speed up precancerous conditions that exist in middle-aged people, similarly to how the hormone estrogen might promote growth of nascent breast tumors.

In separate reviews, Dr. Butler and colleagues, Public Citizen, and the Institute for Safe Medication Practices (ISMP) each found many more cases of pancreatitis and pancreatic cancer reported for the incretin drugs than for Avandia, another Type 2 diabetes drug, The Times said.

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