Fentanyl is a powerful opiate drug, appropriate only for patients who suffer from persistent pain at levels ranging from moderate, to severe. It is also only appropriate for patients who are conditioned to opiate drugs. Thus, the concern that a defective fentanyl patch, either mis-prescribed for a patient not properly conditioned to opiates or, for that matter to a patient medically qualified—could deliver an improperly-high dosage.Duragesic has been described as "innovative". However not innovative enough, it seems, to have been recalled 5 times since 1994 for similar reasons. This time, the recall is again being conducted in tandem with the US Food and Drug Administration (FDA) and warns that potential tears in the reservoir within the patch that contains the fentanyl gel could result in excessively high doses of the powerful opiate being absorbed through the skin.
Fentanyl can kill. It can be especially lethal to people not properly conditioned for the rigors of opiate drugs, and in high doses can pose a risk for anyone.
What's an even greater concern is that a similar recall in February of last year was said to be a much larger recall—and yet the recall was said to have been for a less-potent version of the drug that is currently on the recall list.
As well, the recall a year ago was for products manufactured for Johnson & Johnson subsidiary PriCara by Alza Corporation Of Mountain View, California. Turns out the same company is behind the current fentanyl patch recall, an action that was announced in the dying hours of 2008. Alza, it was reported, has assured in a statement that the latest manufacturing problems have been corrected.
Given the powerful nature of fentanyl, the safety net for the patient only extends to the ability of the Duragesic patch to deliver the opioid drug slowly, and through a controlled fashion, through the skin. The fentanyl gel is contained in a reservoir within the patch. Provided the patch works as designed, the treatment for moderate-to-chronic pain for patients deemed appropriate for fentanyl, is effective.
But then there's that word that rhymes with effective, and that's defective. And defective is what happens when, through a serious of apparent manufacturing problems, the patches arrive from the manufacturer with tears close to, or directly impacting the reservoir. When this happens, the carefully designed dosage strategy inherent with the Duragesic patch is defeated, and the potent fentanyl can do an end-run around the normal delivery system, delivering higher and varying doses of fentanyl through the skin.
According to the product labeling, direct exposure to fentanyl gel can lead to serious adverse incidents or side-effects that can include respiratory depression and possible overdose that could be fatal.
Duragesic CII 50 mcg/hr patches under the lot number 0817239 are being recalled. Sandoz Inc. 50 mcg/hr patches under the lot number 0816851 are also being recalled.
The company has indicated that it expects 6 defective patches in the two lots of 410,000 patches. Other strengths, including 12.5, 25, 75 and 100 mcg/hr, were not affected.
PriCara is a division of Ortho-McNeil-Janssen Pharmaceuticals Inc.—which in turn is part of the massive Johnson & Johnson family. Alza Corp, out of California, has the contract to manufacture the patches.
READ MORE FENTANYL PATCH LEGAL NEWS
The recommendation is to flush the patch down the toilet. However, there was no mention of any potential risk to the municipal water supply, in doing so. The latter is an entirely different issue.
The more direct health concern is that the recalled Duragesic patch can result in serious health issues, even death. If your health, or the health of a loved one has been compromised in any fashion as the result of using a recalled fentanyl patch identified through the Duragesic recall, please consult an attorney. You may have medical bills, and other expenses that should not be your's alone to bear…
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Fran Spruill
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