Product News and Recalls

Byetta manufacturer demands court order before sharing safety information

In the course of an investigation about the class of diabetes drugs that includes Byetta and Januvia, the medical journal BMJ uncovered evidence suggesting that manufacturers tried to repress evidence linking the drugs to serious health problems.

A growing body of evidence has linked incretin therapies such as Byetta and Januvia to both pancreatitis (a potentially deadly inflammation of the pancreas) and pancreatic cancer. Byetta has also been linked to thyroid cancer.

According to an account of the investigation published in BMJ, the alleged link between Byetta and pancreatitis has generated a lawsuit in California against manufacturer Amylin, now owned by Bristol-Myers-Squibb. Lawyers for the plaintiffs asked to see results from a study performed on monkeys prior to the drug’s regulatory approval.

A judge eventually had to overrule the company, which balked at the request. A pathologist from the University of Southern California was asked to study the slides.

He found pathological changes indicating chronic pancreatitis and pancreatic disease in the animal administered the drug – at a rate of about twice that found in the control animals.

According to BMJ, Bristol-Myers-Squibb hasn’t responded to subsequent requests to study the material.

The report quotes the pathologist who conducted the initial review as saying: “Well, if we were looking at human pancreas and saw those changes, I would say yes it’s a concern.”

You should consult with a doctor if you have any ongoing symptoms or health concerns, and before making any changes in medication. You should also consult with a Lopez McHugh attorney if you or a loved one was diagnosed with pancreatic cancer after taking Januvia or Byetta.