FDA Investigating Link Between Diabetes Drugs to Pancreatic Cancer
The Food and Drug Administration (FDA) is investigating new evidence that suggests a group of recently approved diabetes drugs is linked to an increased risk in pancreatic cancer.
Diabetes type 2 drugs include Merck & Co. Januvia, Bristol-Myers Squibb Co. Byetta, Bydureon and Onglyza, Januvia, and Eli Lilly & Co.'s Tradjenta,
and Novo Nordisk A/S's Victoza.
The labels on the drugs currently warn of an increased risk of pancreatitis, or inflammation of the pancreas, but the suggested link to pre-cancerous changes in the pancreas is new.
The agency says samples of pancreas tissue taken from a small number of patients showed inflammation of the pancreas and cellular changes which often occur before a patient gets cancer. The unpublished results come from a group of academic researchers, and the FDA says it is seeking more information, according to the Associated Press.
The FDA suggests patients should continue taking their medicines as directed until consulting with their doctors for further advice. In the meantime, the FDA said it does not have enough information yet to make any conclusions regarding the safety of the drugs.
"These findings were based on examination of a small number of pancreatic tissue specimens taken from patients after they died from unspecified causes," the agency said.
The FDA has asked the researchers to explain how they collected and studied the specimens and to provide tissue samples so the agency can further assess any possible risks.
The agency noted it has previously warned the public about acute pancreatitis, including fatal and nonfatal cases, seen with the medicines. Package insert labels for the class of drugs already warn about risk of the potentially dangerous inflammation.