Flash VIG-news: FENTANYL: reminder of appropriate use in order to minimize the risk of abuse, addiction or accidental overdose

date: 19/06/2018

The abuse or intentional misuse of fentanyl-based medicinal products may result in overdose and/or death. Accidental overdose through the transfer or ingestion of patches can also be fatal.

There is a known risk of addiction, abuse or misuse (non-therapeutic use) associated with fentanyl; it is mentioned in the patient information leaflets and in the summaries of product characteristics (SPC) of these medicinal products, and may cause fatal overdoses. 

Approved indications
Transdermal formulations of fentanyl are indicated in the treatment of severe chronic pain requiring the long-term, continuous administration of opioids. Oral forms are indicated for the treatment of bouts of paroxysmal pain in adults with cancer who are already being administered a morphine-based treatment for chronic pains of cancerous origin. A bout of paroxysmal pain is a temporary exacerbation of a chronic pain that is being controlled by long-term treatment.

Abuse, addiction
Patients with a history of addiction/alcoholism are at greater risk of developing a dependency and abusing treatment with opioids. If treatment with fentanyl is prescribed to such patients, monitoring must be carried out to detect signs of misuse, abuse or addiction.

It is important to clearly inform patients and health care staff of the risks associated with the accidental transfer or ingestion of the patches. Patches must be disposed of in an appropriate manner. This is mentioned in the patient information leaflets and in the SPC for fentanyl-based patches.

Overdose symptoms
Patient information leaflets provide recommendations should symptoms of an overdose appear. For the patches, for example, in the case of unusual drowsiness or respiratory distress manifesting in slower or shallow breathing, it is advisable to remove the patch and to call a doctor or go straight to the nearest hospital, while keeping the patient animated by encouraging them to talk as much as possible. Patient information leaflets for the tablets provide similar recommendations that have been adapted to this galenic formulation.

Drug interactions
The risk of pharmacokinetic and pharmacodynamic interactions is an important element to be taken into consideration when prescribing and delivering fentanyl; details are given in Section 4.5 of the SPC.

Fentanyl-based medicinal products are subject to regulations regarding narcotic substances.

As for all medicinal products, these medicinal products must be kept out of sight and out of reach of children.

The patient information leaflets and SPCs of medicinal products marketed in Belgium are available at http://notices.afmps.be.


Last updated on 22/06/2018