Product News and Recalls

FDA accused of inadequate response to diabetes drugs

An investigation in the medical journal BMJ faults the U.S. Food and Drug Administration for its tepid response to reports that diabetes drugs including Byetta and Januvia may be linked to pancreatitis and pancreatic cancer.

Both the FDA and the European Medicines Agency are conducting investigations into that class of drugs, called incretin mimetics, the story says. And both agencies have confirmed that their own analyses show increased reporting or signals of pancreatic cancer with the drugs, although both agencies have also emphasized that they can’t declare a cause-and-effect relationship.

Still, BMJ said researchers were trying as early as 2009 to make the FDA aware of alarming findings about the drugs.

A 2008 study by researchers at the University of California in Los Angeles found abnormalities in pancreases of rats given Januvia.

Those researchers then went on to review the FDA’s adverse event reporting system. They found increased reports of pancreatitis and pancreatic cancer with both Januvia and Byetta, and an increased risk of thyroid cancer with Byetta.

In 2009, BMJ says, the researchers held a teleconference with high-ranking FDA officials, during which they discussed their findings.

BMJ quotes the lead researcher as saying: “The [response of the FDA] was quite surprising. They seemed to be defending the companies and defending the drugs. They were giving the exact same sound bites that thee companies were giving.”

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.