(Bloomberg) — People taking diabetes drugs such as Merck & Co.’s Januvia were affected by pancreatic cell growth and damage that may turn cancerous, a small study finds.
The study, led by Alexandra Butler and Peter Butler of the University of California, Los Angeles, provides evidence of increased pre-cancerous changes in diabetic patients using so- called incretin mimetics, Public Citizen, a Washington-based public advocacy group, says in a statement last week after the research was published.
The FDA said this month it was reviewing unpublished findings by a group of academic researchers suggesting pre-cancerous cellular changes may be associated with Type 2 diabetes treatments known as incretin mimetics, which also include Bristol-Myers Squibb Co.’s Byetta and Novo Nordisk A/S’s Victoza.
“These findings are in accord with the rapidly increasing number of reports to the U.S. Food and Drug Administration of pancreatic cancer in patients using these drugs compared with diabetics using other drugs,” Public Citizen says.
Doctors have been concerned that this category of diabetes treatments may damage the pancreas since the FDA said in 2007 it received a high number of reports of pancreatitis in patients taking Byetta. The agency issued a similar alert for Januvia in 2009. An analysis of insurance records published last month in the journal JAMA Internal Medicine showed such drugs may double a user’s risk of pancreatitis. That hasn’t stopped these medicines from becoming multibillion-dollar drugs.
Merck disagrees with the study’s hypothesis, is confident in the safety of its drug and hasn’t seen any link between it and pancreatitis or pancreatic cancer, says Kelley Dougherty, a spokeswoman for Whitehouse Station, N.J.-based drugmaker.
“We would remind you that the FDA said last week that the FDA has not reached any new conclusions about safety risks with these medicines, and at this time patients should continue to take their medicine as directed until they talk to their health care provider, and health care providers should continue to follow the prescribing information in the drug labels,” Dougherty says.
Januvia generated about $4.1 billion in 2012 worldwide sales, Merck has reported.
Register or login for access to this item and much more
All Employee Benefit News becomes archived within a week of it being published
Community members receive:
- All recent and archived articles
- Conference offers and updates
- A full menu of enewsletter options
- Web seminars, white papers, ebooks
Already have an account? Log In
Don't have an account? Register for Free Unlimited Access