Fentanyl Pain Patch Misuse Can Be Deadly

Accidental Exposures to Fentanyl Patches Remain Deadly to Children

Fentanyl Pain Patch Misuse Can Be Deadly

Accidental exposure to medication is a leading cause of poisoning in children. Young children, in particular, have died or become seriously ill after being exposed to a skin patch containing fentanyl, a powerful opioid pain reliever. If you suspect that a child has been exposed to a fentanyl patch, call 911 and seek emergency medical help immediately. 

The U.S. Food and Drug Administration urges parents and caregivers to take precautions and make sure that these patches are stored, used, and disposed of properly. Below are some ways to reduce the risk of exposure and safely dispose of these patches, and what to do if a child is exposed to a fentanyl patch.

Children Can Overdose on Fentanyl Patches

The fentanyl transdermal system, which is available as a generic product and marketed under the brand name Duragesic, is a patch prescribed by health care providers to be applied to the skin.

The patch treats opioid-tolerant patients who need daily, round-the-clock, long-term pain medicine by releasing fentanyl through the skin over the course of the treatment.

The patch is generally replaced every three days.

Children can overdose on new and used fentanyl patches by putting them in their mouth or sticking the patches on their skin. This can cause death by slowing the child’s breathing and decreasing the levels of oxygen in their blood. 

The FDA has warned, and continues to warn, patients, caregivers, and health care professionals about the dangers of accidental exposure to the fentanyl patch, and the need to properly store and dispose of the product.

In addition, the FDA recommends that patients and caregivers talk to their health care providers about having naloxone on hand. Naloxone is a life-saving drug that, when sprayed into the nose or injected, can quickly reverse the powerful effects of opioids, including fentanyl, during an overdose. Naloxone can be given to children and anyone who may have been exposed to a fentanyl patch. 

Cut the Risk of Accidental Exposure

If you or someone in your home uses the fentanyl patch, follow the instructions given by the prescriber and in the Medication Guide, which should accompany each fentanyl patch prescription.

To reduce the chance that children will be exposed to fentanyl, take these precautions:

  • Keep fentanyl patches and other drugs in a secure location children’s sight and reach. Toddlers and young children may think the patch is a sticker, tattoo, or bandage.
  • Consider covering the fentanyl patch with a transparent adhesive film to make sure the patch doesn’t come off your body. You can apply first aid tape to the edges of the patch to secure it to your skin.
  • Throughout the day, make sure the patch is still in place, by touching it or looking at it.
  • When you apply a new patch, promptly dispose of the used one properly.

Infants and toddlers are especially at risk of accidental exposure to fentanyl. When children are held by or are sleeping with adults wearing a patch, it is possible that a partially detached patch could be transferred from adult to child.

How to Dispose of Fentanyl Patches

Even after a patch is used, there is enough fentanyl left to cause illness, overdose, or death in babies, children, adults, and pets who are accidentally exposed to the medicine in the patch. That’s why the drug comes with special instructions on how to dispose of used or leftover patches.

The FDA recommends promptly 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. Children may find lost, discarded, or improperly stored patches and ingest them or stick them on themselves or others.

The FDA has included fentanyl patches on a list of medicines that should be flushed down a toilet because they could be especially harmful, and possibly fatal, in a single dose if used by someone other than the person for whom the medicine was prescribed. 

What to Do if a Child Is Exposed to Fentanyl

If you suspect that a child has been exposed to a fentanyl patch, use naloxone if you have it, call 911 and seek emergency medical help immediately. 

Early signs of fentanyl exposure might be hard to notice in young children. Drowsiness has been among the reported symptoms, and that could be misinterpreted as the child just being tired or sleepy.

Other signs that the child may have been exposed to fentanyl include:

  • trouble breathing
  • shortness of breath
  • swelling of the face, tongue, or throat
  • agitation
  • high body temperature
  • stiff muscles

Because overdoses can happen anywhere, naloxone is designed to be used by anyone, even a bystander. You can give naloxone to people of all ages, from infants to elderly adults. Even if you use naloxone, you still need to call 911 and seek emergency medical help right away.

Talk to your health care professional about the benefits of naloxone and how to obtain it. In most states and the District of Columbia, you can obtain naloxone from a pharmacy under a standing order (a prewritten medication order) that takes the place of an individual prescription.

Have Naloxone and Learn How to Use It

Fentanyl, all opioids, should be stored securely. If you have naloxone, tell your family about it, and keep naloxone in a place where family, friends, and close contacts can easily get it in an emergency. If you have naloxone, advise family and friends on how to administer it in the event of an accidental exposure or overdose. 

If you have a question about the fentanyl patch, talk to your health care provider or pharmacist. Also, the FDA’s Division of Drug Information (DDI) will answer almost any drug question. DDI pharmacists are available by email, druginfo@fda.hhs.gov, and by phone, 1-855-543-DRUG (3784) and 301-796-3400.

Health care professionals and patients are encouraged to report cases of accidental exposure to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report online.

Источник: https://www.fda.gov/consumers/consumer-updates/accidental-exposures-fentanyl-patches-continue-be-deadly-children

Asphyxiation with a Fentanyl Patch

Fentanyl Pain Patch Misuse Can Be Deadly

Narcotics are frequently prescribed to alleviate pain in patients with serious medical illnesses such as cancer. Because of their nonoral route of administration, fentanyl patches are now being frequently prescribed.

However, the widespread use of fentanyl patches has been associated with medication errors and misuse [Butts and Jatoi: J Opioid Manag 2011;7:35-45]. The transdermal delivery of fentanyl may lead to unusual, unanticipated complications.

Herein, we describe a fentanyl patch complication, which, to our knowledge, has not been previously reported.

© 2013 S. Karger AG, Basel


Fentanyl patches are often used to alleviate severe pain, particularly in cancer patients. However, the transdermal delivery of fentanyl may lead to unusual complications [1].

Previous reports describe patients chewing on patches, applying more than the number of prescribed patches to the skin, and applying a patch to an area with a skin abrasion — all of which can lead to fentanyl toxicity [1].

Continued vigilance among healthcare providers to detect misuse of this transdermal medication is of paramount importance to prevent untoward adverse events including death.

Herein, we describe a fentanyl patch complication, which meets our Institutional Review Board standards for minimal risk reporting in a de-identified manner, as provided below, and which, to our knowledge, has not been previously reported.


A 60-year-old man presented to our clinic for a follow-up visit, at which time he appeared despondent. Two years prior, he had been struck by a motor vehicle and fractured his first lumbar vertebra.

This fracture was treated with an L1 corpectomy and an instrumented fusion from T12 to L2.

This complication coupled with the diagnosis of cancer, as outlined below, resulted in the patient being treated almost ever since with transdermal fentanyl for a chronic pain syndrome.

A few months earlier, a hematologic evaluation for leukocytosis had led to the diagnosis of systemic mastocytosis with an associated clonal hematologic non-mast cell lineage disease, chronic myelomonocytic leukemia type 1 (CMML-1).

The patient was subsequently found to have leukemia cutis and eosinophilic myocarditis. Symptoms of pruritus and dyspnea improved with high-dose steroids and hydroxycarbamide.

The steroids were tapered slowly over months, and the patient started azacytidine in place of hydroxycarbamide to treat his CMML-1.

However, during this evaluation process and treatment for mastocytosis and CMML-1, the patient remained on a fentanyl patch (100-μg/h patch every 72 h). He had no history of a psychiatric disorder, but he had experimented with psychotropic substances in his youth and had a flat affect at baseline.

When the patient presented for his second cycle of azacytidine, he appeared despondent and described shortness of breath. He provided limited answers to questions, with poor eye contact throughout the interview.

An accompanying friend reported that the patient had been less communicative over the preceding 4 days and had complained of shortness of breath. The patient's heart rate was 96 beats/min, blood pressure 116/77 mm Hg, SpO2 94%, temperature 37.0°C, and respiratory rate 16 breaths/min.

The circumference of the left leg was 5 cm greater than that of his right leg, and his lungs were clear to auscultation. The patient was not wearing a fentanyl patch at the time of this examination.

The results of this presentation raised concerns about a pulmonary embolus, and the patient was thought to be at high risk (Well's score of 7 due to clinical signs of deep venous thrombosis, ly diagnosis of pulmonary embolism, and active malignancy).

He was not treated immediately with anticoagulation due to his thrombocytopenia (36 × 103/μl) and renal insufficiency (creatinine 2.3 mg/dl). A lower-extremity Doppler ultrasound did not reveal occlusive thrombus and chest radiography was unremarkable.

Computerized tomography (CT) of the chest with contrast was not pursued due to renal insufficiency. However, because of declining sensorium concurrent with a dropping blood pressure of 89/45 mm Hg, a CT of his head was obtained.

This imaging revealed an 8-mm left frontal and parietal subacute on chronic subdural hematoma without mass effect; this finding remained stable on subsequent scans.

The patient's worsening mental status and other symptomatology in the setting of an unclear diagnosis prompted hospitalization.

Shortly thereafter, the patient experienced a brief tonic seizure that resolved spontaneously followed by a second more prolonged tonic seizure that involved right gaze deviation and tonic posturing of both arms.

He was treated with lorazepam, and the seizure resolved with no recurrent events. The decision was then made to intubate the patient for airway protection.

Direct laryngoscopy revealed a transparent, folded, plastic-appearing item superior to the glottis. It was removed and identified as a fentanyl patch. Full bronchoscopy was performed to ensure that no other foreign objects had been aspirated, and none were found. Two doses of naloxone 0.4 mg were administered intravenously.

The patient's mental status soon improved and the endotracheal tube was removed. He was evaluated by psychiatry. The patient had no explanation for the discovery of a fentanyl patch in his larynx, but he denied any intention to harm himself. To date, it remains unclear exactly how the patch came to be positioned in this patient's larynx.

The patient was discharged from the hospital with follow-up plans for the treatment of his hematologic conditions.


This case represents an unusual and unexpected complication related to the ongoing use of a fentanyl patch. This patient apparently attempted to ingest a fentanyl patch, which became lodged within his larynx.

Heat can increase the absorption of fentanyl [2], and, perhaps, the higher laryngeal body temperature resulted in increased transmucosal absorption of the medication, hence the manifestations of overdose, despite the patient's long-standing use of this medication.

This case provides further confirmation of the need for sustained, heightened vigilance for drug adherence with transdermal fentanyl. In a systematic review of the complications of opioid medications, fentanyl was the opioid most commonly implicated in such untoward events [1].

The most frequent cases of misuse included drug-drug interactions which potentiated narcotic effects or resulted in serotonin syndrome. Other problems with fentanyl relate to the acceleration of its transdermal absorption or experimentation with alternate routes of administration.

Although external heat sources have been used to maximize the euphoric effects of fentanyl, other patients have suffered unintentional overdoses from hyperthermia [3], sun tanning [4], and warming blankets [5].

Patients have been reported to lick and chew or rectally insert transdermal fentanyl patches, and inject or inhale volatilized extracts from the patches [6]. Mishandling of fentanyl patches has even resulted in unintentional toxicity for caregivers [7]. Misuse of fentanyl can be fatal [8].

Inappropriate use of transdermal fentanyl patches may be more common than currently recognized and should be considered in fentanyl-treated patients who present with signs of narcotic toxicity.

The patient in this report had a near fatal event after asphyxiation with a fentanyl patch. Direct visualization of the fentanyl patch led to this unexpected diagnosis.

This case represents the first report, to our knowledge, of asphyxiation with transdermal fentanyl and highlights the need for an awareness for complications with the use of narcotics, particularly of transdermal fentanyl and particularly under circumstances in which the prescribed patch is absent from the skin.


  1. Butts M, Jatoi A: A systematic compilation of reports published on opioid-related problems. J Opioid Manag 2011;7:35-45.
  2. Moore KT, Sathyan G, Richarz U, Natarajan J, Vandenbossche J: Randomized 5-treatment crossover study to assess the effects of external heat on serum fentanyl concentrations during treatment with transdermal fentanyl systems. J Clin Pharmacol 2012;52:1174-1185.
  3. Rose PG, Macfee MS, Boswell MV: Fentanyl transdermal system overdose secondary to cutaneous hyperthermia. Anesth Analg 1993;77:390-391.
  4. Sindali K, Sherry K, Sen S, Dheansa B: Life-threatening coma and full-thickness sunburn in a patient treated with transdermal fentanyl patches: a case report.

    J Med Case Rep 2012;6:220.

  5. Frolich MA, Giannotti A, Modell JH: Opioid overdose in a patient using a fentanyl patch during treatment with a warming blanket. Anesth Analg 2001;93:647-648.

  6. Nishikawa RK, Bell SC, Kraner JC, Callery PS: Potential biomarkers of smoked fentanyl utilizing pyrolysis gas chromatography-mass spectrometry. J Anal Toxicol 2009;33:418-422.
  7. Gardner-Nix J: Caregiver toxicity from transdermal fentanyl. J Pain Symptom Manage 2001;21:447-448.
  8. Jumbelic MI: Deaths with transdermal fentanyl patches. Am J Forensic Med Pathol 2010;31:18-21.

Aminah Jatoi, MD

Division of Medical Oncology, Mayo Clinic

200 First St SW

Rochester, MN 55905 (USA)

E-Mail jatoi.aminah@mayo.edu

Published online: May 01, 2013
Issue release date: May – August

Number of Print Pages: 3 Number of Figures: 0

Number of Tables: 0

eISSN: 1662-6575 (Online)

For additional information: https://www.karger.com/CRO

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Drug Dosage: The authors and the publisher have exerted every effort to ensure that drug selection and dosage set forth in this text are in accord with current recommendations and practice at the time of publication.

However, in view of ongoing research, changes in government regulations, and the constant flow of information relating to drug therapy and drug reactions, the reader is urged to check the package insert for each drug for any changes in indications and dosage and for added warnings and precautions.

This is particularly important when the recommended agent is a new and/or infrequently employed drug.

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Источник: https://www.karger.com/Article/Fulltext/351220

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