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FDA issues warning about accidental exposure to fentanyl pain patch among young children

Friday, April 20 2012 | Comments
Evidence Grade 0 What's This?
The Food and Drug Administration issued a public safety alert to warn that young children could die or become seriously ill if exposed to the fentanyl transdermal system, which Janssen Pharmaceuticals Inc. markets under the brand name Duragesic and is available in generic formulations.

The agency said there have been 26 cases of accidental exposure to fentanyl since 1997, most of which involved children aged younger than 2 years. Of these 26 cases, 10 resulted in death and 12 resulted in hospitalization. 

Fentanyl is a potent opioid pain reliever. The fentanyl patch is used to treat patients with constant pain by releasing the drug during the course of three days. An overdose of fentanyl can occur if a child swallows the patch or applies it to his or her own skin and can cause death by slowing breathing and increasing blood levels of carbon dioxide.

The FDA cautioned that accidental exposure also can occur when an adult wearing a partially detached patch picks up or holds an infant or toddler and inadvertently transfers the patch to the child.

Children are particularly vulnerable to a fentanyl overdose, according to the FDA, because they have not been exposed to this type of potent drug before and are more vulnerable to its effects. The agency added that a fentanyl patch can still retain more than 50 percent of the active ingredient, even after it has been worn for three days.

To reduce the risk of accidental exposure, the FDA recommends that users dispose of the patches by folding them in half, so that the sticky sides meet, and then flushing them down a toilet.

The agency also advised storing fentanyl patches in a secure location that is out of children's sight and reach. Further, when wearing a patch, users should consider covering it with an adhesive film to ensure it stays in place and should check throughout the day to see that it has not come off.

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