FDA Opens Review of Januvia and Byetta

As many as 25 million Americans suffer from type 2 diabetes and the complications that go along with the disease. While there has been a rise in the number of treatment options over the past few years, there have also been a number of issues associated with some of the drugs. If you have experienced health related problems following the use of Januvia or Byetta, we encourage you to speak with a Tennessee Januvia and Byetta lawyer.

The U.S. Food and Drug Administration (FDA) recently opened a review into type 2 diabetes drugs Januvia and Byetta to determine whether or not the drugs are associated with an increased risk of developing pancreatic cancer. The FDA publicly stated that it “intends to obtain and evaluate” new information regarding type 2 diabetes drugs. These drugs have been subjected to increased scrutiny due to recent reports linking the drugs to possible serious side effects.

In February of 2013, the Journal of American Medical Association published a study revealing that people who were taking type 2 diabetes drugs like Byetta and Januvia had twice the rate of acute pancreatitis. These numbers obviously have doctors very concerned. Specifically, commentary in the British Medical Journal by Edwin A.M. Gale, professor of diabetes medicine at Southmead Hospital in England, provided insight into the potential danger of pancreatitis. Describing the his large level of concern, Gale stated, “All forms of pancreatitis, clinical, or subclinical, predispose to carcinoma of the pancreas.”

However, evidence linking type 2 diabetes drugs to inflammation of the pancreas is nothing new. There have been reports linking Byetta and pancreatitis as early as 2007. The FDA said in 2007 that it had received a high number of reports of pancreatitis from those taking Byetta. Some of these cases even included more serious effects including hemorrhagic and necrotizing pancreatitis and even death.

There have been an increasing number of lawsuits filed against the manufacturers of these drugs, Merck and Bristol-Myers Squibbs. One particular lawsuit was filed by a husband on behalf of his late wife who died one year after developing pancreatic cancer. She had taken both Byetta and Januvia. The lawsuit claims that these particular drugs caused “severe mental and physical pain and suffering” as well as economic loss.

Other lawsuits filed against the manufacturers allege the drugs caused “unreasonable and dangerous side effects.” In addition, the suits claim that the manufacturers failed to warn the public of such harm and concealed the risks from doctors and patients.

If you have any questions regarding a potential Januvia or Byetta lawsuit, feel free to contact one of our experienced Tennessee Januvia lawyers. Our experienced team of defective drug attorneys at The Higgins Firm would be happy to answer them.

American Association of Justice Badge
Justia Badge for
Million Dollar Advocates Forum Badge
Best of the Bar Badge
AV Preeminent Badge