Duragesic: Potentially Lethal in the Wrong Hands

West Palm Beach, FLThe recent recall of Duragesic pain patches should not come as a surprise, given the checkered history of a product that introduces extremely potent pain medication directly through the skin. First approved in 1990, Duragesic has endured several recalls in the last 14 years.

However, 2005 appeared to be a watershed year for concern over the Duragesic pain patch, when the US Food and Drug Administration (FDA) announced that it was investigating 120 deaths. It has been reported that there have been deaths since, although it is unclear just how many deaths have been linked to the pain patch. An FDA spokesperson suggested that while the numbers were small, the concern was due to the fact those deaths were preventable.

This most recent recall appears to have been triggered by a potentially defective patch, which can leak the powerful fentanyl narcotic, leading to inappropriately large doses to either the patient, or a caregiver who might come into contact with the patch.

To understand the issue, one must understand how the patch works—and just what's inside the patch that requires such diligence.

The Duragesic patch, which comes from Novartis and Johnson & Johnson, is designed to stem chronic pain in patients that have been conditioned to the potency of strong, narcotic-based pain medication. Cancer patients, for example, would be a group that might see benefit from the appropriate use of the fentanyl patch, an entity that contains the potent painkiller in a sac, or reservoir within the patch and releases the opioid narcotic in a controlled fashion, through the skin, in order to benefit the patient suffering from chronic pain.

However, according to the FDA, there have been reports where doctors have been found to prescribe the patches for patients suffering from headaches, or for post-surgical discomfort.

It has been suggested that this incorrect use of fentanyl patches are causing a host of adverse reactions, and in some cases a patient's life could be put at risk either from an accidental overdose of the drug, or a regular dose administered to a patient not conditioned for, or unaccustomed to opioid drugs.

"While these products fill an important need, improper use and misuse can be life threatening," says FDA pain chief Dr. Bob Rappaport. "It is crucial that doctors prescribe these products appropriately, and that patients use them correctly."

According to the consumer advocacy Institute for Safe Medication Practices, one patient died after being given a patch for post-surgical pain despite having pneumonia and being new to narcotics. Two others survived—an elderly man taken to the emergency room after being given a patch together with other painkillers, and an elderly woman who became delirious while wearing several patches at once.

This past summer a federal jury awarded $5.5 million to the father of a West Palm Beach man who died while wearing a Duragesic patch. Adam Hendelson was only 23 when he succumbed to the effects of the patch in 2003. Suffering chronic hip pain after a car accident, Hendelson took to wearing the Duragesic patch on his arm in an effort to control the pain.

He was later found dead at his computer with three times the amount of fentanyl that is considered to be a lethal dose, in his system.

While the most recent recall was triggered by the potential for patches to leak fentanyl from the internal reservoir, the incident rate is so small that it pales when compared to the bigger issue. And that is, the potential for inappropriate prescriptions on the part of doctors, and the lack of awareness on the part of the patient who might liken the Duragesic patch as being akin to taking an aspirin.

It is certainly furthest from the truth. Fentanyl is powerful and can be lethal if used, or prescribed incorrectly.

While the product already comes with a black box warning, the FDA earlier this month asked the manufacturer to make available special medication guides which would accompany every container of Duragesic patches, correctly spelling out proper use in easily-understood language. It has been suggested that incorrect application, or replacement of the patch can lead to a potential overdose.

Included in the material would be reminders that the application of pain medication through the skin is just as, or even more effective than oral ingestion. Many patients thinking that the skin serves as a barrier (when compared to the seemingly more direct path via oral ingestion) might be more inclined to double-up for good measure.

And both doctor and patient need to keep in mind the potency of the drug, and its inappropriateness for patients as yet unconditioned to narcotics. Fentanyl should never be a patient's first exposure to narcotic-based pain medication.