Following U.S. Study, European Union Investigating Diabetes Drugs


Following news in the United States about a recent study that found that Type 2 diabetes drugs, such as Januvia and Byetta, might place patients at increased risk for pancreatic damage, including pancreatic cell growth that could lead to cancer, Europe’s top drug watchdog began is own investigation.

The European probe was initiated weeks after regulators in the U.S. started their own, similar investigation, said Law360. The European Medicines Agency (EMA) said that it is basing its investigation on a recent article published in the journal Diabetes. That article, noted Law360, suggests that incretin mimetics may lead to increased risks for pancreatic issues such as pancreatitis and pancreatic duct metaplasia, which are precancerous cellular changes.

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. Diabetics 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.

Although the FDA said it has not reached any new conclusions about the safety risks associated incretin mimetics, the agency informed the public and the health care community that it intends to secure and evaluate the new research that reveals links between these Type 2 medications and increased risks for pancreatic diseases, including cancer of the pancreas. The EMA issued a statement indicating that it had not reached a conclusion on the drugs’ safety, said Law360 and that its Committee for Medicinal Products for Human Use and Pharmacovigilance Risk Assessment Committee is conducting an investigation “to determine the need for possible further regulatory action,” according to Law360.

The study on which the FDA made its announcement was conducted at the University of California, Los Angeles, and led by researchers Alexandra Butler and Peter Butler. “These findings are in accord with the rapidly increasing number of reports to the U.S Food and Drug Administration of pancreatic cancer in patients using these drugs compared with diabetics using other drugs,” Public Citizen said, wrote Bloomberg News.

Prior research also revealed that Januvia and Byetta have been associated with reports of increased risks for pancreatic and thyroid cancers. Another new study also found that the drugs may double patients’ risks for developing pancreatitis, the first time a study put a number to the risk. In the United States, about 8.6 percent of the population—25 million people—were diagnosed with diabetes in 2010, based on prior Bloomberg News data. That number is expected to rise to more than 34 million by 2020.

Pancreatitis is an inflammation of the pancreas that is linked to cancer and kidney failure. Chronic pancreatitis is painful, potentially fatal, and a known risk factor for pancreatic cancer. Other serious side effects have been linked to these Type 2 diabetes drugs including 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 heomorrhagic pancreatitis; pancreatic cancer; thyroid cancer; vomiting and nausea; anorexia; persistent, severe abdominal pain, sometimes radiating to the back; and death.

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