Millions of Americans live with type-2 diabetes and many are taking some of the medications now at the focus of a couple of concerning reports.
A newly published report finds people taking some diabetes drugs are facing a higher than expected number of startling effects on the pancreas, a possible precursor to cancer. The research was conducted by Alexandra and Peter Butler at the University of California-Los Angeles and colleagues at the University of Florida.
Published in the journal “Diabetes” the drugs named – Byetta, Victoza and Januvia – all GLP-1-mimicking diabetes drugs – were associated with an increase in precancerous changes such as dysplasia in the pancreas. Among 20 diabetics there was a 40 percent increase in pancreatic cells and cell damage among those on Byetta (exenatide), Victoza (liraglutide) and Januvia (sitagliptin) – also known as incretin drugs.
Although the agency has not reached any final conclusions, the Food and Drug Administration announced this month it too is reviewing unpublished studies suggesting a link between precancerous cellular changes in the pancreas and Byetta (Bristol-Myers Squibb), Victoza (Novo Nordisk) and Januvia (Merck).
The FDA issued a similar concern for Byetta and changes to the pancreas as early as 2007 and for Januvia in 2009. The Institute for Safe Medication Practices found Byetta and Victoza accounted for 43 percent of adverse event reports to the FDA of acute and chronic pancreatitis.
In June the agency will conduct a workshop on the diabetes treatment/pancreatitis debate before issuing a final recommendation.
Merck in a statement to Bloomberg News said it disagrees with the hypothesis and confirmed the safety of its drug.
Beginning in January 2010, the researchers searched the Food and Drug Administration’s adverse event database and found a total of 292 reports of pancreatic tumors. During the same time period there was only one report of a tumor among patients taking the more commonly prescribed drug glipizide, approved in 1984 and sold as Glucotrol (Pfizer).
In the adverse events findings, the pancreatic cancer and pancreatic tumors were suspected to be caused by the drugs and when the researchers dug further into the FDA database they found the tumor patients did not list any history of alcohol abuse or smoking, two other suspected causes of pancreatic tumors.
In February, a published report in the Journal of the American Medical Association found patients on Byetta, Bydureon or Januvia roughly doubled their risk of acute pancreatitis.
Public Citizen’s Dr. Sidney Wolfe notes that for more than two years beginning in January 2010 there were at least 35 million prescriptions written for the standard treatment glipizide, while there were 33 million prescriptions written for the incretin drugs.
Last year Public Citizen petitioned the FDA to ban Victoza (liraglutide) because of a suspected link to thyroid cancer and pancreatic disease but now the group suspects the entire family of drugs is suspect.
Considering there is a standard drug that’s been on the market longer without the suspected complications, Public Citizen believes a stronger warning label would be a reckless and irresponsible alternative. The advocacy group believes nothing short of an entire ban of these drugs will suffice.