The U.S. Food and Drug Administration warned Wednesday the public
of the potential for a deadly overdose of a pain drug for cancer
patients made by Cephalon Inc.
The warning comes after Cephalon earlier this month warned
doctors about several patient deaths related to inappropriate
prescribing of the drug, called Fentora.
Fentora is approved only for treating pain in cancer patients
who experience breakthrough pain because they have developed
tolerances to other opiate painkillers, such as morphine etc.
But many doctors prescribe the drug "off-label" for headaches
and back pain. Once a drug has been approved by the FDA doctors are
free to prescribe it as they see fit.
The FDA said that several Fentora-related deaths have occurred
in patients who were prescribed the drug for off-label use.
It warned that Fentora should not be used for any other
conditions. It should also only be given to patients who have
developed opiate tolerance, as others will not be able to handle
the high amounts of fentanyl contained in Fentora.
Finally, the administration warned people taking Fentora and
their caregivers to carefully follow the drug's label directions.
The agency also advised that patients and caregivers become
familiar with the signs of fentanyl overdose.
(Agencies via Xinhua News Agency September 27, 2007)