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FDA warnings a result of inappropriate use – how to use fentanyl patches correctly

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Durogesic (Fentanyl transdermal system) is a long term opioid based painkiller system first approved in 1990. However, following several cases of patients overdosing on Durogesic the US Food and Drug Association has released several warnings regarding the correct use of the Fentanyl transdermal system.1  

Indications for Durogesic use

Durogesic is indicated in patients with long term, moderate to severe pain that is constant. It is recommended only for patients who are already on an opiate analgesic and this is reducing their pain.

Durogesic is not recommended for:2

  • patients with short term, post-operative or intermittent pain
  • patients with a history of chronic pulmonary disease, hypotension, increased intracranial pressure, impaired immunity or renal impairment
  • patients with a history of drug or alcohol abuse 
  • children
  • pregnant mothers
  • opioid naive patients

It is important to also assess any possible drug interactions which may be significant. These include other opioids, sedatives, hypnotics and antidepressants.

Dosing of Durogesic

Durogesic is available in doses of 12, 25, 50 and 100 micrograms per hour. It is recommended that patients start on a dose of 12 or 25 micrograms per hour and this should be increased by 12 or 25 micrograms every 3 days if needed. Patients should be on the minimum dose needed for symptom control.2

Signs of Durogesic overdose

The signs of Durogesic overdose are:1

  • trouble breathing or shallow breathing
  • extreme sleepiness or sedation
  • inability to think, talk or walk normally
  • feeling faint, dizzy or confused

The patient and their family or caregiver should be made aware of these signs and should be instructed to seek medical attention immediately if these signs become present.

Common causes of Durogesic overdose

Some of the common causes of Durogesic overdose include:1,3

  • use other medicines that affects the brain such as sedatives
  • drinking alcohol
  • having an increase in body temperature or being exposed to heat. This includes having a fever, using electric blankets or hot baths.
  • use of other medicines that affect how fentanyl is broken down in the body. This includes several antibiotics (such as erythromycin), ketoconazole and diltiazem.

Please note that correct disposal of used patches is essential. If a child applies, even a used patch, this may cause an overdose in that child and may lead to death.3

Correct use of Durogesic

Below is the correct procedure the apply the Durogesic Patch. Please note that for the medication to be used safely this procedure must be followed exactly.4

  1. Find an intact and hairless spot of skin, preferably on the torso, or on the upper arm. The skin must be healthy and undamaged. Do not place the patch onto skin that is red, burnt or damaged.
  2. Trim any excess hair with scissors. Do not shave the hair off since this may affect the skin.
  3. Wash the skin with water, do not use soap, lotions or moisturisers. Then dry the skin, the skin should be completely dry before applying the patch.
  4. To open the pouch, locate the pre-cut notch indicated by the scissors. Make a small cut and fold at the notch. Carefully tear the pouch along the edge and then fully open the pouch by folding it open like a book.
  5. Remove the Durogesic patch from the sealed pouch.
  6. Do not apply the patch if it looks damaged in any way. Never cut or divide the patch.
  7. Each Durogesic patch has a clear plastic protective (release) liner that can be peeled off in two pieces. After folding the patch in the middle, peel off each part of the protective liner separately. Avoid touching the adhesive side of the patch.
  8. Apply the patch to the skin and press with the palm of the hand for about 30 seconds. Make sure all of the patch is in contact with skin and the corners are stuck tightly.
  9. Wash hands after applying or removing the patch.
  10. Write the date and time that the patch was applied on the pack as a reminder as to when the patch must be replaced.

The patch can be left on the skin for three days (72 hours), after which it must be removed and disposed of. When the patch is on the patient can bath, shower or swim, but it is important to avoid saunas or hot tubs as these increase temperature, blood flow to the skin and therefore uptake of Fentanyl.

Important patient education when started Durogesic

It is important to fully educate the patient before starting them on Durogesic. Several important points include:3

  • Durogesic has a slow onset of action, it may take some time for it to become effective, the patient should have other analgesic options available during this time
  • Patients should be given clear instructions about the correct use and disposal of Durogesic patches. 
  • Patient should be advised about the common side effects (nausea, constipation and sedation), how long these will last and how to manage them. 
  • Patient should be warned about possible causes of overdose (listed above)
  • Patient and their family or caregiver should be educated about the signs of Durogesic overdose

Follow-up of patient

It is important to follow-up these patients closely. This follow-up can include:3

  • Observing the patient applying the patch and ensuring that the correct procedure is followed
  • Inspecting the skin to check for any irritation and correct placement of patch
  • Monitoring initial side effects (nausea and sedation) and wether these subside
  • Monitoring ongoing side effects (most importantly constipation)
  • Assessing adequacy of pain control and adjusting dose of Durogesic and breakthrough analgesia as required.


  1. FDA Public Health Advisory. Safety Warnings Regarding Use of Fentanyl Transdermal (Skin) Patches.  US Food and Drug Administration; 2007. Available from
  2. CMPMedica Australia. eMIMS. Version 5.01.0088. St Leonards: CMPMedica Australia; 2007
  3. Deglin JH, Vallerand AH (Ed). Davis’ drug Guide for Physicians. F.A. Davis Company; 2005
  4. Janssen Pharmaceutica Products. Patient Information DURAGESIC (Fentanyl transdermal system). Janssen; 2003. Available from <>
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Posted On: 12 March, 2008
Modified On: 16 January, 2014


Created by: myVMC