JANSSEN PHARMACEUTICA INC.
URGENT DRUG RECALL
April 2, 2004
Dear Healthcare Professional:
This is to inform you that Janssen Pharmaceutica Products, L.P., is expanding the recall of DURAGESIC® (fentanyl transdermal system) CII 75 mcg/hour patches to include five manufacturing lots (control numbers 0327192, 0327193, 0327294, 0327295, and 0330362). Patches from all other 75 mcg/hour and all 25, 50 and 100 mcg/hour patches are not part of this recall.
Some DURAGESIC patches from the recalled lots may leak medication due to improper sealing of one of their edges.
If medication leaks out of the patch, exposure to the medication could result in inadvertent ingestion or an increased trahsdermal absorption of the active opiate component fentanyl, leading to potentially life-threatening complications. In addition, leakage of medication could lead to inadequate dosing, resulting in treatment failure and/or opiate withdrawal.
Healthcare professionals, caregivers, or anyone who comes in contact with medication that may leak from DURAGESIC 75 mcg/hour patches from these lots (control numbers 0327192, 0327193, 0327294, 0327295, and 0330362) may be at risk of potentially life-threatening complications. Drug exposure among these persons could be more clinically significant because such individuals may not be opiate-tolerant. Anyone who comes in contact with the leaked medication is advised to rinse exposed skin thoroughly with water only: soap should not be used.
Please refer to the attached instructions on how to handle questions regarding the DURAGESIC 75 mcg/hour patches from recalled lots .
Guidance is provided on:
• Determining the affected lots of the product
• How to remove the patch
• How to handle used patches; and
• Obtaining a new supply of DURAGESIC 75 mcg/hour patches for the patient as soon as possible.
Information for Healthcare Professionals responding to questions regarding DURAGESIC® 75 mcg/hour patch (control numbers 0327192, 0327193, 0327294, 0327295, and 0330362)
PHYSICIANS/PRESCRIBERS
1. Assist the patient in determining whether they have a patch with the recalled control numbers 0327192, 0327193, 0327294, 0327295, and 0330362.
a. The control numbers for the patches from the recalled lots appear on both the bottom flap of the outer carton and on the back of each foil pouch that contains a patch.
b. Patients using DURAGESIC 25 mcg/hour, 50 mcg/hour, 100 mcg/hour, or DURAGESIC 75 mcg/hour patches that are not from the recalled lots (control numbers 0327192, 0327193, 0327294, 0327295, and 0330362) can continue to use them. Sudden discontinuation of DURAGESIC can cause serious health problems.
2. If the patch is from a recalled lot, it should be removed and replaced with a new 75 mcg/hour patch from an unaffected lot, or a combination of 25 mcg/hour and/or 50 mcg/hour patches (or alternative therapy you may elect to prescribe) immediately after confirming availability with the pharmacy.
• Confirm availability of patches from unaffected lots or alternative therapy you may elect to prescribe.
• Remove the patch, wearing rubber gloves if possible, or, if not, using tissue
• Discard the patch by folding and flushing the used patch in the toilet.
• Thoroughly rinse your hands and the area where the patch was applied gently with a soft cloth and plain water. Do not use soap or rub the area excessively.
• Anyone who comes in contact with the leaked medication should thoroughly rinse exposed skin with water only: do not use soap.
3. Help the patient obtain a new supply of DURAGESIC 75mcg/hour patches as soon as possible. Sudden discontinuation of DURAGESIC can cause serious health problems. Contact the patient's pharmacist to let them know that the patient will be returning any unopened pouches and seeking replacement supply. The patient should replace patches from the recalled lots immediately.
- If replacement 75 mcg/hour patches from unaffected lots are not immediately available, a suitable substitution may be made by writing a prescription for a 50 mcg/hour patch and a 25 mcg/hour patch, or three 25 mcg/hour patches.
- Please follow all applicable state and federal prescribing regulations for Schedule II substances as appropriate for the situation.
- Patients should return all unopened DURAGESIC 75 mcg/hour pouches (with control numbers 0327192, 0327193, 0327294, 0327295, and 0330362) to their pharmacist (preferably the pharmacy that dispensed the prescription).
4. Report adverse events and product defects relating to DURAGESIC to Janssen Pharmaceutica Products, L.P. at 1-800-JANSSEN (1-800-526-7736), or to the FDA MedWatch Program by phone (1-800-FDA-1088), by fax (1-800-FDA
0178), by mail (using postage-paid form to MedWatch, FDA, 5600 Fishers Lane , Rockville , MD 20852-9787 ) or via www.accessdata.fda.gov/scripts/ medwatch .
Please see attached Full Prescribing Information, including Boxed Warnings .
Patients using DURAGESIC 25 mcg/hour, 50 mcg/hour, 100 mcg/hour, or DURAGESIC 75 mcg/hour patches that are not from the recalled lots (control numbers 0327192, 0327193, 0327294, 0327295, and 0330362) can continue to use them. Sudden discontinuation of DURAGESIC can cause loss of efficacy and/or opioid withdrawal.
Janssen Pharmaceutica Products, L.P. is committed to the integrity of its products and the health and safety of the patients who use them. For more information about this product recall, please visit www.DURAGESIC.com or www.Janssen.com . The Web sites contain written materials and photos of the outer carton and foil pouch illustrating the location of the control numbers. For those without Internet access, please call 1-800-JANSSEN (1-800-526-7736).
Report adverse events and product defects relating to DURAGESIC to Janssen Pharmaceutica Products, L.P. at 1-800-JANSSEN (1-800-526-7736), or to the FDA MedWatch Program by phone (1-800-FDA-1088), by fax (1-800-FDA-0178), by mail (using postage-paid form to MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787) or via www.accessdata.fda.gov/scriipts/medwatch .
Please see attached Full Prescribing Information, including Boxed Warnings.
Sincerely,
/
Christine Cote, M.D.
Vice President, Medical Affairs
Janssen Pharmaceutica
1125 TRENTON-HARBOURTON ROAD
POST OFFICE BOX 200 TITUSVILLE , NEW JERSEY 08560-0200 (609) 730-2000
us.janssen.com 01-DR-953
