Fentanyl
(FEN ta nil
Brand Names: Duragesic, Ionsys,

What is the most important information
I should know about Fentanyl topical?

Keep both used and unused fentanyl topical patches or devices out of the reach of children or pets. The amount of fentanyl in these units can be fatal to anyone or pet who  sucks on or swallows the unit. Seek emergency medical attention if this happens immediately.

Before using fentanyl topical, tell your doctor if you have a breathing disorder such as chronic obstructive pulmonary disease (COPD). You should not use fentanyl topical if you have had an allergic reaction or severe side effects when using any narcotic pain medicine.
Fentanyl topical may be habit-forming and should be used only by the person it was prescribed for. This medication should never be given to another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it. Fentanyl can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. You should not use a Duragesic skin patch unless you are already being treated with a similar opioid pain medicine and your body is tolerant to it. Opioid medicines include morphine (Kadian, MS Contin, Oramorph, and others), oxycodone (Oxycontin), and hydromorphone (Dilaudid). Talk with your doctor if you are not sure you are opioid-tolerant.

Avoid drinking alcohol, or using other medicines that make you sleepy (such as cold medicine, other pain medication, muscle relaxers, and medicine for seizures, depression or anxiety). They can add to sleepiness caused by fentanyl and may cause extreme drowsiness or breathing problems.

What is Fentanyl Topical?
Fentanyl is a narcotic (opioid) pain medicine.

The Duragesic fentanyl skin patch is used to treat moderate to severe chronic pain. The Ionsys fentanyl transdermal device is used only in a hospital to treat acute pain after surgery.
Fentanyl topical may also be used for purposes other than those listed in this medication guide.

What side effects can this medication cause?

Fentanyl skin patches may cause side effects. Tell your doctor if any of these symptoms or those listed in SPECIAL PRECAUTIONS are severe or do not go away:

* headache
* mood changes
* nervousness
* depression
* difficulty falling asleep or staying asleep
* shaking hands that you cannot control
* pain, burning, tingling, or numbness in the hands or feet
* dry mouth
* hiccups
* stomach pain
* indigestion
* gas
* back pain
* difficulty urinating
* itching
* skin irritation, redness, itching, swelling, or blisters at the area where the patch is worn
* flu-like symptoms
* sore throat

If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately:

* heartbeat that is slower or faster than normal
* chest pain
* rash
* seizure

FDA News

FDA Issues Second Safety Warning on Fentanyl Skin Patch
Deaths and serious injuries from improper use

The Food and Drug Administration today issued its second safety warning about the fentanyl transdermal system, an adhesive patch that delivers a potent pain medicine through the skin. In July 2005, the agency issued a similar warning to the public and to health care providers, saying that the directions on the product label and on the patient package insert should be followed exactly in order to avoid overdose. FDA has continued to receive reports of deaths and life-threatening side effects after doctors have inappropriately prescribed the patch or patients have incorrectly used it.   

In addition, the agency is asking manufacturers of all fentanyl patches to update their product information and to develop a medication guide for patients.

The fentanyl skin patch contains the opioid fentanyl, a potent narcotic. The skin patch was approved by FDA in 1990 for use in patients with persistent, moderate-to-severe pain who have become opioid tolerant – meaning that they have been using another strong opioid narcotic pain medicine around-the-clock, and have been using the medicine regularly for a week or longer. The skin patch is most commonly prescribed for patients with cancer.

Recent reports to FDA describe deaths and life-threatening side effects after doctors and other health care professionals inappropriately prescribed the patch to relieve pain after surgery, for headaches, or for occasional or mild pain in patients who were not opioid tolerant. In other cases, patients used the patch incorrectly: The patients replaced it more frequently than directed in the instructions, applied more patches than prescribed, or applied heat to the patch – all resulting in dangerously high fentanyl levels in the blood.

“There is an unmet need to provide patients suffering from chronic pain with safe and effective products that will not only alleviate their pain, but that will also be tolerable when used chronically,” said Bob Rappaport, M.D., FDA’s director of the Division of Anesthesia, Analgesia and Rheumatology Products. "While these products fill an important need, improper use and misuse can be life-threatening. Therefore, it is crucial that doctors prescribe these products appropriately and that patients use them correctly."

In its Public Health Advisory and Health Care Professional Sheet published today, FDA stressed the following safety information:

• Fentanyl patches are only for patients who are opioid-tolerant and have chronic pain that is not well controlled with other pain medicines. The patches are not to be used to treat sudden, occasional or mild pain, or pain after surgery. 
• Health care professionals who prescribe the fentanyl patch, and patients who use it, should be aware of the signs of fentanyl overdose: trouble breathing or slow or shallow breathing; slow heartbeat; severe sleepiness; cold, clammy skin; trouble walking or talking; or feeling faint, dizzy, or confused. If these signs occur, patients should get medical attention right away.
• Patients prescribed the fentanyl patch should tell their doctor, pharmacist and other health care professionals about all the medicines that they take. Some medicines may interact with fentanyl, causing dangerously high fentanyl levels in the blood and life-threatening breathing problems.
• Patients and their caregivers should be told how to use fentanyl patches. This important information, including instructions on how often to apply the patch, reapplying a patch that has fallen off, replacing a patch, and disposing of the patch, is provided in the patient information that comes with the fentanyl patch.
• Heat may increase the amount of fentanyl that reaches the blood and can cause life-threatening breathing problems and death. Patients should not use heat sources such as heating pads, electric blankets, saunas, or heated waterbeds or take hot baths or sunbathe while wearing a patch. A patient or caregiver should call the patient’s doctor right away if the patient has a temperature higher than 102 degrees while wearing a patch.

This information will be reflected in the updated product information new medication guides for patients that manufacturers are being asked by FDA to develop.

The fentanyl skin patch is marketed under the brand name Duragesic by Johnson and Johnson, and generic versions of the product are sold by other manufacturers.