Future of Type 2 Diabetes Drugs Threatened

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.

To all current and prospective clients, please be advised that while we are open for business and working remotely, effective Tuesday March 17th, our offices will be closed to the public. All of our attorneys will continue to advocate for their clients and are available via telephone, email/or videoconference. Our receptionist will continue to answer the phone and connect you with our attorneys and staff as needed. To our prospective clients, we are here for you to answer questions and to consult with free of charge as usual. Consultations can be conducted by telephone or videoconference. We hope everyone and their families are safe and sound during this unusual time. Please call or email us with any questions or concerns. Thank you! Close