Following Death, FDA Renews Alert for Child Safety and Painkiller Patches

The Federal Drug Administration (www.fda.gov) has issued an updated alert regarding the danger to child safety and the now popular painkiller patches. This most recent alert follows two previous alerts regarding the patches that were issued in in 2005 and 2006. This alert was prompted by the recent death of a 2-year-old boy in Wisconsin who was accidentally exposed to the patch.

This most recent incident prompted the FDA to evaluate its own data regarding the patches. Upon review, the FDA has received 26 reports of accidental exposures to fentanyl patches by children over the past 15 years. The unfortunate result in 10 of these cases was the death of a child, with another 12 resulting in hospitalization. In 16 of the reported cases, accidental exposure occurred in children aged two years or younger.

FentanylThe patch is a clear, adhesive strip. It is much like a piece of tape that contains a strong pain medication, usually fentanyl. Also known as a transdermal patch, the product is intended to release a preset amount of the drug into a patient’s system over a period of several days. The patch allows easier and safer dosing when used according to the instructions by allowing for continuous, around-the-clock use and eliminating the need to schedule medication times and doses.

Children are at greatest risk for accidental exposure to lost or discarded patches because their natural curiosity leads them to discover patches when stored within their reach. Sometimes the patches are discarded into trash cans, or they fall off the intended patient and on to the ground or floor. It is not uncommon for the patches to then be ingested by a child or to get stuck to their skin.

In the most recent incident, the victim’s family believes the child may have obtained the patch during a nursing home visit to see his great-grandmother. The patch may have dislodged from a patient or may not have been disposed of properly, eventually finding its way into the boys Halloween bucket or on to one of his toy trucks. The boy discovered the patch, and unknown to his parents, may have swallowed it like a piece of candy. The boy was later found unresponsive in his bed, with the patch stuck to the inside of his throat.

This tragic incident highlights the need for health care professionals, as well as patients, to educate themselves on proper care and disposal when using the powerful patches.

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