Duragesic: This Painkiller Patch Can Kill

Washington, DCIf you're on 'the patch,' then you're either trying to quit smoking, or you have a chronic condition which leaves you in a great deal of pain, the kind of pain that only a Duragesic, or similar pain patch containing the powerful opioid fentanyl, can stem.

The trouble is, they could also leave you dead, due to a defect that has prompted two recalls within a week.

Last Tuesday pain patches marketed in the US as Duragesic by PriCara and also in generic form by Sandoz, were recalled due to a potential for accidental overdose by way of a small cut, or leak in a few of the patches.

While few patches are suspected—a small handful amidst a million or so—it's what can happen if too much fentanyl is released at once, or comes into contact with someone other than the patient during handling, such as a caregiver, that is cause for concern.

The powerful fentanyl drug is stored in gel-form within an internal reservoir inside the patch. If this reservoir lining is cut, or breached in any way, some of the gel can ooze out onto the packaging, and could come into contact with the skin of a caregiver, or handler.

This contact could potentially cause difficulty breathing, and if left unchecked could lead to a potentially fatal overdose as the fentanyl opioid is ingested through the skin.

The Duragesic recall involves all 25 microgram-per-hour patches carrying expiration dates on, or before December 9th of next year.

Manufacturer PriCara estimates that two patches out of every million included in the recall have the defect that causes the leak.

The recalled patches were also sold in Canada under the Duragesic brand by Janssen-Ortho Inc. and generically by Ranbaxy Laboratories Ltd.

All of the patches were manufactured by PriCara affiliate ALZA Corp. PriCara is a division of Ortho-McNeil-Janssen Pharmaceuticals, Inc.

Less than a week later, on February 18th another fentanyl pain patch was recalled, citing similar concerns. This time it's the Actavis patch, which actually carries two different names and only adds to the confusion. The patches recalled on the 18th are identified as having both Actavis South Atlantic LLC, and the company's former moniker, Abrika Pharmaceuticals Inc. on the packaging.

Specifically, the old name will be seen on the inner pouches containing the patches, while the new, Actavis name will be found on the outer carton.

Monday's recall includes 25-microgram-per-hour, 50-microgram-per-hour, 75 microgram-per-hour and 100 microgram-per-hour patches with expiration dates of May through August of 2009.

It was advised during both recalls that damaged patches that appear to have a cut, or tear in the inner lining allowing gel to ooze out, should be flushed away, and hands or any skin exposed should immediately be rinsed with water, but not with soap.

The latter recalled patches were manufactured for Actavis Inc. by Corium International Inc. Actavis Inc. is a division of Actavis Group HF.

These powerful pain patches are normally prescribed for patients with chronic pain, and are deemed appropriate for patients conditioned to narcotic pain medications, such as cancer patients, as an example. To someone lacking such conditioning, inadvertent exposure to fentanyl could prove dangerous, as would exposure to additional amounts of fentanyl over and above that which the patch is designed to release in an engineered, time-release fashion.

Both scenarios could potentially result in a fatal overdose. The pain patches are designed and approved for the treatment of chronic pain within a narrow set of parameters, however it has been reported that the US Food and Drug Administration (FDA) has been made aware of some doctors prescribing the patches for post-surgical pain, and even headaches.