The widely-prescribed type 2 diabetes drugs Byetta and Januvia may double the risk of users developing pancreatitis, an inflammation of the pancreas that can lead to cancer and kidney failure. The new information, which was published in the journal JAMA Internal Medicine, found that patients hospitalized with pancreatitis were twice as likely to be taking Januvia or Byetta than a control group of diabetics who didn’t have the disease. Concerns have been raised about these types of diabetes medications since at least 2007, when Byetta was first linked to pancreatitis.
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How can Byetta and Januvia cause pancreatitis?
The Byetta and Januvia study, which analyzed insurance record data from 2005 to 2008, showed a doubling in pancreatitis cases.
“This is the first real study to give an estimate of what the risk is, until now we just had a few case reports,” said Sonal Singh, the study’s author and an assistant professor of medicine at Johns Hopkins University in Baltimore. “These drugs are effective in lower glucose, but we should also consider the risk of pancreatitis and balance the risk versus the benefit.”
Pharmaceutical giant Merck & Co. reported $4 billion in sales (app. 9% of total revenue) from Januvia last year. The drug is designed to block an enzyme that breaks down GLP-1, a hormone that stimulates insulin production in the pancreas. Janumet, a diabetes drug that combines Januvia and metformin, generated $1.7 billion in sales for Merck last year.
Bristol-Meyers acquired Byetta last year when it purchased Amylin Pharmaceuticals for about $5 billion. The drug, which mimics GLP-1, generated nearly $150 million in sales for Bristol-Meyers in 2012, as well as approximately $159 million for Eli Lilly, which ended its marketing partnership with Amylin in 2011.
In addition to Byetta and Januvia, other medications that increase the level of GLP-1 in the body include Onglyza and Victoza. The JAMA study only looked at Byetta and Januvia because the other drugs weren’t on the market during the study period. Byetta was approved by the FDA in 2005, with Januvia entering the market a year later in 2006.
In diabetics, pancreatitis occurs in approximately 3 in 1,000 patients. A doubling of this risk would drive that number to about 6 in 1,000 for patients taking Byetta or Januvia. In 2010, nearly 9% of our nation’s population (approximately 25 million Americans) had diabetes, according to data compiled by Bloomberg News. Experts have estimated this number will rise to more than 34 million by 2020.
The JAMA study looked at a cohort of 1,268 diabetic test subjects who had been hospitalized with pancreatitis and compared them to the same number of patients who did not have the disease. Among those with pancreatitis, 87 were Byetta or Januvia users, compared with 58 in the control group. When adjusting for variables that can make an individual more susceptible to developing pancreatitis, the researchers determined there was a doubling of the risk among Byetta and Januvia users.
Byetta, Januvia and Pancreatic Cancer
Singh said additional research needs to be conducted to determine conclusively whether Byetta and Januvia have the potential to cause full-blown pancreatic cancer.
“We really need to know more about these drugs as pancreatitis is on the pathway to pancreatic cancer,” he said.
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Free Confidential Case Evaluation: If you or a loved one has been diagnosed with cancer after taking Byetta or Januvia, you should contact our law firm immediately. You may be entitled to compensation by filing a suit and our lawyers can help.