The agency said Thursday samples of pancreas tissue taken from a small number of patients showed inflammation and cellular changes that often precede cancer. Academic researchers took the samples from diabetes patients who were taking the new medications, after they died from various causes.
Details of the research have not yet been published, but the agency said in an online statement it is seeking more information. While the FDA has issued previous alerts about the pancreatitis risk, the agency had not notified the public about pre-cancerous cell changes seen with the drugs. For now, regulators say they are still investigating the issue.
"FDA has not concluded these drugs may cause or contribute to the development of pancreatic cancer," the agency said in an online statement. "At this time, patients should continue to take their medicine as directed until they talk to their health care professional."
The FDA previously added information about cases of pancreatitis, some of them fatal, to the labels of Byetta in 2007, and Januvia and Janumet in 2009. A recent study of insurance records found that use of those drugs could double the risk of developing acute pancreatitis, according to the FDA. Januvia is a once-a-day pill. Janumet combines the drug with metformin, a decades-old drug commonly prescribed for diabetes.
Byetta is a twice-a-day injection originally developed by Amylin Pharmaceuticals. Bristol-Myers acquired the drug last year, along with the newer formulation Bydureon, which is taken once-a-week. Byetta and Bydureon are part of a drug class that mimics the GLP-1 hormone, triggering insulin production after a meal. Januvia and Janumet work by blocking the DPP-4 enzyme, which spurs release of more insulin from the pancreas. Those drugs brought in a total of about $5.75 billion last year, making them Merck's biggest franchise.
The pancreas produces various hormones, including insulin, that help the body break down sugar. Pancreatitis causes an inflammation of the organ and can lead to fatal complications, including difficulty breathing and kidney failure.
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2 comments:
No illness is simple and although some drugs may help to alleviate the sympton the cause is always there. Caution and weighing up pro's and cons is needed far more these days. Is there a safe time allowed for proper research? What does a layman do other than read up on information available and in consultation with their GP's do what they think best. We are not immortal but we do our best to extend life as far as we can.
Paul B
Big pharma have proved beyond all doubt they cannot be trusted. Far too many Doctors have been blinded by bent science. Some people have to take medication to live, but so many drugs for diabetes are unnecessary as are statins. Why take a risk with drugs when diet and lifestyle can achieve far more safely ?
Eddie
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