July 11, 2005
FDA ALERT
MedWatch - The FDA Safety Information and
Adverse Event Reporting Program
Duragesic (fentanyl transdermal system): safety in formation
extensively revised
Janssen and FDA notified healthcare professionals of
changes to the BOXED WARNING/WARNINGS,CONTRAINDICATIONS,PRECAUTIONS,
and DOSAGE AND ADMINISTRATION sections of the prescribing
information for Duragesic.
These changes include important safety information in
the following areas of the labeling: Use Only in Opioid-Tolerant
Patients, Misuse, Abuse and Diversion, Hypoventilation
(Respiratory Depression), Interactions with CYP3A4 Inhibitors,
Damaged or Cut Patches, Accidental Exposure to Fentanyl, Chronic Pulmonary
Disease, Head Injuries and Intracranial Pressure, Interactions with Other
CNS Depressants, and Interactions with Alcohol and Drugs of Abuse.
Read the complete MedWatch 2005 Safety summary, including
a link to the Dear Healthcare Professional letter, at:
http://www.fda.gov/medwatch/SAFETY/2005/safety05.htm#Duragesic