DURAGESIC PATCH RECALL!

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Drug Company Recalling Pain Patches

Feb 16, 2004

(HOPEWELL, N.J.) Janssen Pharmaceutica 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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not be published, broadcast, rewritten, or redistributed. The Associated

Press

contributed to this report. )