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From:  Janssen

March 11, 2004

Clinical Information: urgent notification

As a patient who uses DURAGESIC (fentanyl Transdermal system) CII patches, there is important new information about the patch that you need to know.

The problem...  You may have heard recent news reports that a specific lot of DURAGESIC 75mcg/hr patches were recalled by Janssen Pharmaceutical Products, L.P.The reason for this recall was that a small percentage of patches in this lot had a potential leak along one edge of the patch, which could allow some of the medication inside the patch to leak out.

This problem has been seen, rarely, in other lots  of Duragesic, and Jenseen has taken immediate steps to correct it.  However, you should be alert to the rare possibility of receiving a patch with a leak.  You should follow the updated DURAGESIC handling and applicatio instructions, which are described below.                                                                               

The DURAGESIC patch contains a strong narcotic medication in the form of a gel.  When used normally, the medication inside the patch is slowly delivered into the skin through the adhesive side of the patch.  If the medication leaks from the patch, patients can get either too much or too little medication.  If medication gets in a patient's mouth or eyes, he or she may be exposed to too much medication.  This overexposure may cause nausea, sedation, drowsiness, or potentially life-threatening complications.  If the medication leaks out of the patch, there may not be enough to provide adequate pain control and the patient may experience withdrawal symptoms.  These include sweating, sleeplessness, and abdominal discomfort. All new patients What you should do...

If you should ever come in contact with the gel by mistake, you should know what to do to be safe

If you observe moisture or gel in the pouch containing a DURAGESIC patch, do not use it and call your pharmacist or physician for instructions. Remember: do not touch the gel.

If you do have uninteded contact with the gel, either because you touched the sticky side of the patch or because of a leak or tear in the patch, immediately wash the affected area with large amounts of water only.

if you still have concerns once you have thoroughly washed the affected area, speak with your pharmacist or physician for further instructions.

For more information about safely applying and using DURAGESIC, speak with your doctor, pharmaxist, or visit www.duragesic.com, where you can find important safety information, illustrations showing how to apply the patch, and answers to frequently asked questions.

   If you have any questions or concerns about using the DURAGESIC patch, please call the Janssen Contact Center at 1-800-JANSSEN (1-800-526-7736).        Sincerely,           

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