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Transdermal patches that release the potent opioid, fentanyl, is still causing deaths due to wrong use. The FDA said in its second warning in two years about the powerful narcotics.

 

The FDA first warned about improper patch use in 2005 (http://www.fda.gov/cder/drug/infopage/fentanyl/default.htm), when it announced it was investigating 120 deaths. Some of the deaths came after doctors prescribed the patches to the wrong patients. The drug is only licensed for chronic pain and to be used on non-opioid naive patients such as cancer patients. Yet the FDA found cases where doctors prescribed it for headaches or post-surgical pain. Patients also accidentally overdose by using the patches wrong, such as putting on more than prescribed, replacing them too frequently or getting them occluded which resulted in high transdermal flux of the potent narcotic into the circulation. Respiratory depression is one of the most dangerous side effects where in toxic doses can lead to death.

Even the number of reports have been small but concerning because "they are preventable" through better counselling, more prudent patient selection etc. The consumer advocacy Institute for Safe Medication Practices highlighted some cases last summer. One patient died after being given a patch for post-surgery pain despite having pneumonia and being opiate-naive. Two others survived, an elderly man taken to the emergency room after being given a patch together with painkilling pills and an elderly woman who became delirious while wearing several patches at once.

The FDA's main message: Do not prescribe fentanyl patches to anyone new to opioids, the painkiller family that includes morphine. Absorbing fentanyl through the skin is a powerful way to deliver the potent drug, and thus poses serious risk to anyone not already opioid-tolerant. Doctors who aren't specially trained in pain management may not know that. As pharmacist, we must be very vigilant when dealing with fentanyl patch and other potent narcotics.

US FDA is highlighting the following important safety information on the fentanyl skin patch:
• The fentanyl patch should only be used by patients who are opiod-tolerant and have chronic pain that is not well controlled with other pain medicines.
• Healthcare professionals who prescribe and patients who use the fentanyl patch should be aware of the signs of fentanyl overdose including the following: trouble breathing or slow or shallow breathing; slow heartbeat; severe sleepiness; cold, clammy skin; trouble walking or talking; or feeling faint, dizzy, or confused. If these signs occur, patients or their caregivers should get medical attention right away.
• Patients prescribed the fentanyl patch should tell their doctor about all the medicines that they take.
• Patients and their caregivers should be told how to use the fentanyl patch. The link to that information can be found in the transcript of this podcast.
• Heat may increase the amount of fentanyl that reaches the blood and can cause life-threatening breathing problems and death.


For more info, visit: http://www.fda.gov/cder/drug/podcast/fentanyl?overview.htm

 

 

 

 

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