Future of Type 2 Diabetes Drugs Threatened

Posted in Dangerous Drugs on June 6, 2013

According to The New York Times, an animal study requested by Merck for its type 2 diabetes drug, Januvia, revealed worrisome changes in the pancreases of rats, leading to follow-up studies which now threaten the future of the lucrative diabetes drug, as well as all other drugs in its class.

When Merck originally approached Dr. Peter C. Butler, chief of the division of endocrinology at UCLA, to test whether Januvia would help defend against diabetes in rats, he refused. Ultimately, the study was conducted and revealed that the drug caused changes in the pancreas that could lead to pancreatic cancer. This discovery, in early 2008, and follow-up studies have placed Januvia, Byetta and other type 2 diabetes drugs of the same class under scrutiny. In fact, based on Dr. Butler’s latest study, the European Medicines Agency and the U.S. Food and Drug Administration (FDA) have initiated investigations that could result in new drug warnings, complete removal from the market, or potentially no action at all. According to Dr. Butler, studies done by drug companies that lead to FDA approval tend to involve young healthy animals, not elderly, weakened or infirm populations characteristic of patients taking these medications.

More than 100 lawsuits have been filed across the U.S. against Bristol-Myers claiming injury, mainly pancreatitis, from Byetta. According to Merck, 43 lawsuits have been filed against Januvia with claims that it caused pancreatic cancer.