FDA studies possible pre-cancerous link with diabetes drugs

Thu Mar 14, 2013 11:20am EDT

March 14 (Reuters) - The U.S. Food and Drug Administration
is studying unconfirmed  reports that a widely used class of
diabetes drugs, which includes Merck & Co's Januvia, may
cause inflammation of the pancreas and pre-cancerous changes to
the pancreas.
    The agency, in a notice on its website on Thursday, said it
is the first time it has communicated potential pre-cancerous
links to the medicines, known as incretin mimetics. The oral
treatments also include Bristol-Myers Squibb Co's 
Onglyza.
    Patients should continue taking their medicines as directed
until speaking with health care professionals, the agency said.
The FDA said it is investigating findings from academic
researchers that highlighted the potential risk. 
    "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.
    In the meantime, the FDA said it has not reached any new
conclusions about safety risks of the class of drugs.
    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.
    Merck's Januvia and its related drug called Janumet, had
combined sales last year of almost $6 billion, making them by
far the company's biggest product franchise. Onglyza and a
related drug called Kombiglyze had sales last year of $709
million.
    Shares of Merck were down 1.3 percent, while Bristol-Myers
slipped 0.5 percent, in morning trading on the New York Stock
Exchange.
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