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01/18/1994

<TITLE>Warning Against Misusing of Fentanyl (Duragestic) Analgestic Skin Patch</TITLE>








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<PRE>
P94-2                              Food and Drug Administration
FOR IMMEDIATE RELEASE              June R. Wyman - (301) 443-3285
     
     The Food and Drug Administration today announced that Janssen
Pharmaceutica is warning health care professionals about misusing
its fentanyl (Duragesic) analgesic skin patch and is taking steps
to restrict the patch's use.
     These actions come after a few isolated instances of misuse of
Duragesic were implicated in preventable patient deaths. 
     The company has sent a letter to all health care
professionals, revised the product's labeling, added warning
language to the product's packaging, and will revise patient
instructions to include warnings of possible side effects.
     "There is evidence that this product is being misused in ways
that put patients in danger," said FDA Commissioner David A.
Kessler, M.D.  "We are taking steps to protect future patients by
making sure that the drug is prescribed safely."
     Because serious or life-threatening breathing problems can
occur, Duragesic is:
     o  not to be used to manage acute or postoperative pain,
including pain after outpatient surgery.
     o  not to be used for mild or intermittent chronic pain that
can be managed with less powerful drugs.
     o  not to be started at a dose higher than 25 micrograms per
hour.
     o  not to be used by children under age 12, or by patients 
                             -MORE-


                                    Page 2, P94-2, fentanyl    
under age 18 who weigh less than 110 lbs., except in FDA-approved
research settings.
     Duragesic is to be used only for the management of severe,
chronic pain (such as cancer pain) that cannot be managed with less
powerful drugs such as acetaminophen-opioid combinations and 
nonsteroidal analgesics.  Moreover, the patch should be used only
by patients who are already on and tolerant to opioid therapy, and
who require continuous opioid administration.
     FDA approved the Duragesic patch in 1990.  The patch releases
fentanyl, a strong opioid, continuously at a fixed rate for 72
hours.
     Janssen Pharmaceutica, Titusville, N.J., is the U.S.
distributor of Duragesic, which is manufactured by the ALZA
Corporation, Palo Alto, Calif.
     FDA is one of eight Public Health Service agencies in HHS.
                              ####

</PRE>





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