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FDA Updates Fentanyl Transdermal Patches Prescribing Information


In December 21, 2007, the Food and Drug Administration (US FDA), the equivalent to the Saudi Food and Drug Authority (SFDA), updated an important information on appropriate prescribing, dose selection, and the safe use of the fentanyl transdermal system.

The fentanyl patch is only indicated for use in patients with persistent, moderate to severe chronic pain who have been taking a regular, daily, around-the-clock narcotic pain medicine for longer than a week and are considered to be opioid-tolerant.

Recommendations and Considerations for Healthcare Professionals:

· The fentanyl patch is indicated for the management of persistent, moderate to severe chronic pain in opioid-tolerant patients 2 years of age or older who require a total daily opioid dose at least equivalent to fentanyl transdermal system 25 mcg/h. Opioid-tolerant patients are those who have been taking daily, for a week or longer, at least 60 mg of morphine, 30 mg of oral oxycodone, or at least 8 mg of oral hydromorphone or an equianalgesic dose of another opioid. Fentanyl patch use in non-opioid tolerant patients has resulted in fatal respiratory depression.

· Consult the prescribing information to determine the initial fentanyl patch dose. Overestimating the dose when converting patients from another opioid analgesic can result in fatal overdose with the first dose.

· The fentanyl patch is contraindicated in the management of post-operative pain, mild pain, or intermittent pain (e.g. use on an as needed basis) because of the risk for serious or life-threatening respiratory depression. Fatalities from fentanyl overdose have occurred in these situations.

· Concomitant use of the fentanyl patch with any cytochrome P450 3A4 inhibitors (such as ketoconazole, erythromycin, nefazodone, diltiazem, or grapefruit juice) may result in an increase in fentanyl plasma concentrations, which may cause potentially fatal respiratory depression. Carefully monitor patients concomitantly taking cytochrome P450 3A4 inhibitors and using the patch for an extended period of time and adjust the fentanyl dose if necessary

Information for Patients:

  • The fentanyl patch contains fentanyl, a very strong opioid narcotic medicine that can cause life-threatening breathing problems and death if it is not used correctly. Use the patch exactly as prescribed by your doctor.
  • Only use the fentanyl patch if you have been regularly taking other strong narcotic pain medicines for at least a week. If this is not your situation, talk to your doctor about other options for managing your pain. The patch must not be used to treat mild pain or pain following surgery, medical or dental procedures.
  • Tell your doctor about all the medicines you take. Some medicines may interact with the fentanyl released from the patch and result in dangerously high levels of fentanyl in your blood that could lead to serious and life-threatening breathing problems.

Life-threatening breathing problems can happen because of an overdose. Call your doctor right away or get emergency medical help if you have:

o trouble breathing or slow or shallow breathing

o slow heartbeat

o severe sleepiness

o cold, clammy skin

o trouble walking or talking or feeling faint, dizzy, or confused

· Read and understand the instructions for applying the fentanyl patch that you receive with your prescription. Apply the patch to intact skin. If it falls off before 72 hours, fold the sticky side together and flush down a toilet. Put a new one on at a different skin site. Be sure to let your doctor know that this has happened.

· Heat may increase the amount of fentanyl that reaches your blood and can cause life-threatening breathing problems which can lead to death.

o Do not use heat sources such as heating pads, electric blankets, saunas, or heated waterbeds while wearing a fentanyl skin patch.

o Do not take hot baths or sun bathe while wearing a patch.

o Call your doctor right away if you get a fever higher than 102ºF.

Report Adverse Drug Reactions to the Saudi FDA:

Public and health professionals are encouraged to report adverse drug

reactions to the National Pharmacovigilance Center on the Internet at: