Duragesic (pain patch) recall

February 21, 2004

For those who wear Duragesic patches, this recall notice is of

importance. (From Associated Press February 16, 2004.

Pain Patches Recalled (For More Information Call 800-526-7736)

Janssen Pharmaceutical Products is recalling about 440,000 of its 75

mcg-per-hour prescription DURAGESIC patches, which are used to treat

moderate to severe chronic pain.

The company said Monday that less than 19,000, or under 5 percent of the

440,000 patches from manufacturing lot with the control number 0327192,

may leak medication along one edge. No other lots or dosage strengths

are affected.

If the medication leaks from the patch, patients can get either too much

or too little medication. Exposure to too much medication can occur if

the medicine leaks directly onto the skin and the body absorbs a higher

than intended amount. This overexposure may cause nausea, sedation,

drowsiness, or potentially life-threatening complications. If the

medication leaks out, there may not be enough to provide adequate pain

control and the patient may experience withdrawal symptoms. These

include sweating, sleeplessness and abdominal discomfort.

Health care professionals, caregivers, or anyone who comes in contact

with an affected patch from this lot also may be at risk, the company

said. Anyone who comes in contact with the leaked medication should

thoroughly rinse exposed skin with water only; do not use soap.

Those who have patches from the affected lot should contact their

physician or pharmacist for specific instructions, and to coordinate

returning affected patches and obtaining a new supply.

Patients wearing DURAGESIC patches that are not from the affected lot

can

continue to wear them. Sudden discontinuation of DURAGESIC can cause

health problems. DURAGESIC is a prescription transdermal opioid

medication indicated for the

treatment of moderate to severe chronic pain. The affected lot was

shipped to distributors in the United States between mid-December 2003

and early January 2004.

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