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Painkiller Patches Cause Accidental Deaths in Children

Worst Pills, Best Pills Newsletter article February, 2014

On Sept. 23, 2013, the FDA announced that it would change the labeling on fentanyl painkiller patches (DURAGESIC) to prevent accidental exposure in children.[1] Two days later, subscribers to WorstPills.org received an emailed alert informing them of the risks to children and advising them of necessary precautions.

Since 1997, the Food and Drug Administration (FDA) has received 32 reports of children suffering adverse events after accidental exposure to fentanyl. Most of these...

On Sept. 23, 2013, the FDA announced that it would change the labeling on fentanyl painkiller patches (DURAGESIC) to prevent accidental exposure in children.[1] Two days later, subscribers to WorstPills.org received an emailed alert informing them of the risks to children and advising them of necessary precautions.

Since 1997, the Food and Drug Administration (FDA) has received 32 reports of children suffering adverse events after accidental exposure to fentanyl. Most of these incidents involved children younger than 2 years old. Twelve children have died from exposure, and 12 more required hospitalization but did not die. In 2005, we alerted Worst Pills, Best Pills readers of the concern about special dangers to children in the FDA black box warning that stated: “DURAGESIC should be administered to children only if they are opioid-tolerant and 2 years of age or older.”

About fentanyl

Fentanyl is a synthetic narcotic that relieves pain. It may be administered as an injection (commonly used in surgery), a lozenge or a transdermal patch.

The patch is used to treat patients with persistent, moderate to severe chronic pain that requires around-the-clock opioid administration for an extended period of time and cannot be managed by other means. It works by releasing the medicine over the course of three days. Patients may use the fentanyl patch if they have swallowing difficulties or poor veins. Others may simply find the patch formulation to be convenient. However, it is not used for mild or intermittent pain, and it is not usually used until doses of oral morphine have become high and frequent.

An overdose of fentanyl, as can happen when a patient uses a ripped or otherwise damaged patch, can cause death by slowing breathing and increasing the levels of carbon dioxide in the blood. Fentanyl is not recommended for those weighing less than 110 pounds.

Exposure in children

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. According to the FDA, there is still some risk to a child even when a patch is discarded after having been worn for the full three days of treatment, because a used patch retains more than 50 percent of the medication.

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 the adult’s body and sticks to the child.

Labeling changes

The labeling changes announced by the FDA will apply to the generic and brand-name versions of the product. The label will now 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 spot.)

“We hope that this change will enable patients and caregivers to more easily find patches that need to be removed from patients’ bodies and also to see patches that have fallen off, which could put children, pets or other household contacts at risk for accidental exposure,” says Douglas Throckmorton, M.D., deputy director of the FDA’s Center for Drug Evaluation and Research.

What You Should Do

If you have children in your house, you should work to reduce the possibility of their accidental exposure to fentanyl. The FDA recommends 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.
  • Dispose of used patches by folding in half with the sticky sides together, then flushing them down the toilet (see box below).

Safe Disposal of Unused Medications

Many medicines are harmful, or even fatal, when ingested by children, pets or others for whom the medication was not intended. Unintentional exposure to medications represents a leading cause of accidental poisonings in the U.S. Of the 255,732 reported instances of improper medicine use logged by Poison Control Centers in the U.S. in 2007, roughly 9 percent, or 23,832 cases, involved accidental exposure to medicines. Of these, about 5,000 cases involved children 6 years of age or younger.

It is unnecessarily risky to keep medicines in the house after they are no longer needed. Furthermore, you should not rely on child-resistant packaging to protect young people from accessing unused medications. One study published in 2006 looked at cases in which children were accidentally exposed to their grandparents’ medicine, finding that in nearly half (45 percent) of these cases, the medication had been stored in containers with child-resistant packaging.

For most medications, the FDA recommends disposal through either medicine take-back programs, where they are available, or by simply placing the unused drugs in the household trash. The agency suggests that consumers mix the medicines (being careful to not crush tablets or capsules) with an unpalatable material like coffee grounds. The mixture should then be placed in a sealable plastic bag before being thrown in the trash can.

Certain drugs — including fentanyl — present especially harmful or even deadly risks when taken by someone other than the intended user. The FDA recommends that these medications should be disposed of by flushing them down the toilet rather than placing them in the household trash.

The FDA maintains a list of medications that should be flushed down the toilet for safer disposal. You can view this list, as well as information regarding environmental concerns, by visiting www.fda.gov and typing “disposal of unused medicines” in the search box.

For questions about the safe disposal of medications, please contact the FDA at 1-888-INFO-FDA (1-888-463-6332).

As stated above, the FDA 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.

Early signs of fentanyl exposure can be hard to identify in children. If you suspect that a child has been exposed to a fentanyl patch and the child seems lethargic, contact emergency medical help right away.[2]

References

[1] Food and Drug Administration. Fentanyl patches can be deadly to children. http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm300803.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery. Accessed February 24, 2014.

[2] Ibid.

Disclaimer

The information on this website is not intended to substitute for professional medical advice, diagnosis, or treatment. Consult your doctor before changing or discontinuing any medication.