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September 25, 2013
On September 23, 2013, the Food and Drug Administration (FDA) approved labeling changes to the fentanyl patch (brand name: Duragesic), used to treat pain, in an effort to prevent accidental exposure in children.[1] Since 1997, the FDA has received 32 reports of accidental exposure to fentanyl patches, most of which involved children younger than 2. Twelve children have died from exposure, and twelve more had to be hospitalized but did not die.
Fentanyl patches contain a...
September 25, 2013
On September 23, 2013, the Food and Drug Administration (FDA) approved labeling changes to the fentanyl patch (brand name: Duragesic), used to treat pain, in an effort to prevent accidental exposure in children.[1] Since 1997, the FDA has received 32 reports of accidental exposure to fentanyl patches, most of which involved children younger than 2. Twelve children have died from exposure, and twelve more had to be hospitalized but did not die.
Fentanyl patches contain a powerful opioid pain reliever, used to treat patients in moderate to severe chronic pain, by releasing the medicine over the course of three days. Children exposed to the drug are at risk of death because an overdose of fentanyl can slow breathing and increase the levels of carbon dioxide in the blood.
The new labeling changes, which also will apply to the generic version of the product, will have the name of the drug and its strength printed in long-lasting ink that is clearly visible to patients and caregivers. Previous ink colors varied by strength and were sometimes difficult to read.
A child can overdose on fentanyl patches by putting the patch in his or her mouth or applying it to the skin (like an adhesive bandage or sticker), possibly after finding a patch on the ground or in the trash. Exposure also can occur when an adult wearing a partially detached patch picks up an infant or toddler and fails to notice when the patch peels off and sticks to the child.
To reduce the possibility of accidental exposure, the FDA recommends that fentanyl patch users take these precautions:
- Keep fentanyl patches and other drugs in a secure location out of children’s sight and reach. Toddlers may think the patch is a sticker, tattoo or bandage.
- Consider covering the fentanyl patch with an adhesive film to make sure the patch doesn’t come off your body.
- Throughout the day, check to be sure that the patch is still in place.
The FDA also recommends disposing of used patches by folding them in half with the sticky sides together, and then flushing them down a toilet. They should not be placed in the household trash where children or pets can find them. Even a discarded patch that has been used for three days still contains 50 percent of the original levels of fentanyl, making it dangerous for children and pets.
To view the FDA announcement, see http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm300803.htm.
References
[1] Food and Drug Administration. Fentanyl patch can be deadly to children. September 23, 2013. http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm300803.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery. Accessed September 25, 2013.
