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Information for Healthcare Professionals FDA ALERT 7/15/2005; Update 12/21/2007: This update highlights important information on appropriate prescribing, dose selection, and the safe use of the fentanyl transdermal system. In July 2005, FDA issued a Public Health Advisory and Information for Healthcare Professionals that emphasized the appropriate and safe use of the fentanyl transdermal system (fentanyl patch), marketed as Duragesic and generics). Despite these efforts FDA has continued to receive reports of death and life-threatening adverse events related to fentanyl overdose that have occurred when the fentanyl patch was used to treat pain in opioid-naïve patients and when opioid-tolerant patients have applied more patches than prescribed, changed the patch too frequently, and exposed the patch to a heat source. The fentanyl patch is only indicated for use in patients with persistent, moderate to severe chronic pain who have been taking a regular, daily, around-the-clock narcotic pain medicine for longer than a week and are considered to be opioid-tolerant. Patients must avoid exposing the patch to excessive heat as this promotes the release of fentanyl from the patch and increases the absorption of fentanyl through the skin which can result in fatal overdose. The directions for prescribing and using the fentanyl patch must be followed exactly to prevent death or other serious side effects from fentanyl overdose. These directions are provided in the current prescribing information and Instructions for Applying a Fentanyl Transdermal Patch and the new Medication Guide for patients http://www.fda.gov/cder/foi/label/2005/19813s039lbl.pdf This information reflects FDA’s current analysis of data available concerning this drug. FDA intends to update this when additional information or analyses become available. To report any unexpected adverse or serious events associated with the use of this drug, please contact the FDA MedWatch program and complete a form on line at http://www.fda.gov/medwatch/report/hcp.htm or report by fax to 1-800-FDA-0178, by mail using the postage-paid address form provided on line, or by telephone to 1-800-FDA-1088. Healthcare professionals who prescribe the fentanyl transdermal system (fentanyl patch) should be fully aware of all the prescribing information and should instruct patients on the proper use of the fentanyl patch. Healthcare professionals who prescribe the fentanyl transdermal system (fentanyl patch) should be fully aware of all the prescribing information and should instruct patients on the proper use of the fentanyl patch. The FDA and manufacturer are revising the current labeling to highlight the following safety information in the prescribing information and Instructions for Applying a Fentanyl Transdermal Patch and a new Medication Guide for patients. Recommendations and Considerations for Healthcare Professionals
Information for the patient: Physicians who are prescribing the fentanyl patch should ensure that their patients and their caregivers understand the following:
Background Information and Data On July 15, 2005 FDA issued a Public Health Advisory and Information for Healthcare Professionals that described reports of death and other serious adverse events related to narcotic overdose in patients using fentanyl patches for pain control. At that time, the prescribing information was updated to add new safety information and the manufacturer of Duragesic, Janssen Pharmaceutical Products, issued a “Dear Healthcare Professional” letter that described the changes to the prescribing information. Despite these efforts, FDA has continued to receive reports that indicate physicians are still inappropriately prescribing and patients are continuing to incorrectly use fentanyl patches. The reports indicate that physicians have prescribed the patch to treat acute or intermittent pain in opioid-naïve patients. Also, reports reveal that patients have applied more fentanyl patches than prescribed, changed patches too frequently, and/or exposed patches to a heat source. In some situations, patients have experienced severe respiratory depression and some have died due to fentanyl overdose. At the request of FDA, the manufacturers of fentanyl transdermal systems are revising the prescribing information, and patient instructions for use and are developing a new Medication Guide for patients.
Date created: December 21, 2007
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