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U.S. Department of Health and Human Services

Safety

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Duragesic (fentanyl) Transdermal System


Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- February 2008

 

The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary.


Summary View

 

Sections Modified Summary of Changes to Contraindications and Warnings

BOXED WARNING

WARNINGS

PRECAUTIONS

  • Information for Patients (see highlighted label)

MEDICATION GUIDE

  • Read the Medication Guide that comes with Duragesic before you start using it and each time you get a new prescription. There may be new information...

BOXED WARNING

...Because serious or life-threatening hypoventilation could occur, Duragesic (fentanyl transdermal system) is contraindicated:

  • in the management of intermittent pain (e.g., use on an as needed basis [prn])...

The concomitant use of Duragesic with all cytochrome P450 3A4 inhibitors (such as ritonavir, ketoconazole, itraconazole, troleandomycin, clarithromycin, nelfinavir, nefazodone, amiodarone, amprenavir, aprepitant, diltiazem, erythromycin, fluconazole, fosamprenavir, grapefruit juice, and verapamil)...

Duragesic patches are intended for transdermal use (on intact skin) only. Do not use a Duragesic patch if the seal is broken or the patch is cut, damaged or changed in any way...

Avoid exposing the Duragesic application site and surrounding area to direct external heat sources, such as heating pads or electric blankets, heat or tanning lamps, saunas, hot tubs, and heated water beds, while wearing the system. Avoid taking hot baths or sunbathing. There is a potential for temperature-dependent increases in fentanyl released from the system resulting in possible overdose and death...

WARNINGS

Duragesic patches are intended for transdermal use (on intact skin) only. Do not use Duragesic patch if the seal is broken or the patch is cut, damaged or changed in any way...

Based on a pharmacokinetic model, serum fentanyl concentrations could theoretically increase by approximately one-third for patients with a body temperature of 40ºC (104ºF) due to temperature-dependent increases in fentanyl released from the system and increased skin permeability...