March 15, 2013
FDA Launches Probe Into Diabetes Drug Over Pancreatic Cancer Risk
Lee Rannals for redOrbit.com — Your Universe Online
The Food and Drug Administration (FDA) is looking into findings published by a group of researchers suggesting diabetes drugs have a link to pancreatic cancer.The FDA said it is reviewing unpublished findings that suggest pre-cancerous cellular changes could be associated with specific Type 2 diabetes drugs known as incretin mimetics. These findings were based on examination of a small number of pancreatic tissue specimens taken from patients after they died from unspecific causes.
The agency said it asked the researchers to provide the methodology to collect and study these specimens and to provide the tissue samples so it can further investigate potential pancreatic toxicity associated with the drug.
Drugs in the incretin mimetic class work by mimicking the incretin hormones that the body produces naturally to stimulate the release of insulin in response to a meal. These drugs are used along with diet and exercise to lower blood sugar in adults with Type 2 diabetes.
"This early communication is intended only to inform the public and health care professionals that the Agency intends to obtain and evaluate this new information," the agency said in a statement. "FDA will communicate its final conclusions and recommendations when its review is complete or when the Agency has additional information to report."
Questions about the drug and its effects on the pancreas have been raised before, and the drug's label even contains warnings about the risk of acute pancreatitis. However, researchers at the American Diabetes Association´s (ADA) 69th Scientific Sessions in 2009 concluded that incretin mimetics did not increase the risk of pancreatitis in patients with diabetes.
In February, John Hopkins researchers wrote in JAMA Internal Medicine contradicting the findings in 2009, saying the drugs are associated with an increased risk of hospitalization for acute pancreatitis. They said agents in drugs under the brand names Januvia and Byetta contribute to the formation of lesions in the pancreas and the proliferation of ducts in the organ.
“These agents are used by millions of Americans with diabetes. These new diabetes drugs are very effective in lowering blood glucose. However, important safety findings may not have been fully explored and some side effects such as acute pancreatitis don´t appear until widespread use after approval,” says study leader Sonal Singh, M.D., M.P.H., an assistant professor in the Division of General Internal Medicine at the Johns Hopkins University School of Medicine.
The FDA ensured that patients should still be taking their medicine as directed until they talk to their healthcare professional. Also, health care professionals should be following the prescribing recommendations for drug labels.