Duragesic, also known as fentanyl or transdermal, is a pain patch that is worn on the skin as a topical treatment for chronic pain. It is a narcotic analgesic. The Duragesic patch allows medicine to be absorbed slowly through the skin at a constant rate for up to three days. The patches come in different strengths, and more than one patch may be worn at a time.

Recent Concerns About The Duragesic Pain Patch

Janssen Pharmaceutica has issued two different recalls for defective Duragesic Pain Patches. The patches were recalled because they leak medication due to improper sealing of one of their edges which can result in an overdose. The active ingredient in these Duragesic Pain Patches is fentanyl, a strong opioid for sever pain management.

Duragesic Pain Patches dispense medication through the skin over an extended time usually to people suffering from chronic and/or debilitating pain. If you or a loved one has been injured by a defective Duragesic Pain Patch, contact the Injury Law Offices of BAGOLIE FREIDMAN now for a confidential and free consultation.

On April 27, 2005 the FDA approved revisions to safety labeling of fentanyl transdermal systems, including Duragesic, that stated the patch is associated with a risk of serious or life-threatening hypoventilation that may occur at any time during the use of the patch.

On July 15, 2005 the FDA issued a health advisory warning regarding the use of the Duragesic patch due to recent reports of overdoses and death in those who were using the potent narcotic medication as a pain reliever.

Hypoventilation is one of the most common serious adverse side effects. Hypoventilation is breathing that is too shallow or too slow and is therefore not adequate to meet the needs of the body. It also causes reduced lung function. Hypoventilation results in an inadequate oxygen supply getting into the bloodstream due to a rise in the carbon dioxide level.

There has been an expanded recall of Duragesic Patches (fentanyl transdermal) due to possible leaks. Janssen Pharmaceutica notified healthcare professionals of an expanded recall of Duragesic 75 mcg/h, in February, 2004. Four additional lots are subject to the present expanded recall. Some patches from the recalled lots may leak medication due to improper sealing of one of their edges.

If the medication leaks out of the patch, exposure to the medication can result in inadvertent ingestion or increased transdermal absorption of the active opiate component fentanyl, leading to potentially life-threatening complications. In addition, leakage of the medication could lead to inadequate dosing, resulting in treatment failure and/or opiate withdrawal.

Duragesic Patch – Who is At Risk?

The fentanyl in the Duragesic patch can be habit-forming and addictive, and is therefore not for use by those who have not used any kind of opiate painkiller before. Fentanyl slows down the nervous system. The Duragesic patch should also not be used on children under 12 years of age or in children under the age of 18 who weigh less than 110 pounds. Significant heat can result in an increase of fentanyl release from the patch and so should be kept out of extreme temperatures.

The Duragesic patch is indicated for the management of severe, chronic pain (such as cancer pain) that cannot be managed with less powerful drugs such as acetaminophen-opioid combinations and nonsteroidal analgesics although it may be used by those who have suffered from chronic back pain, arthritis, cervical pain, chronic regional pain syndrome, or migraines.

Only patients who are already on and tolerant to opioid therapy, and who require continuous opioid administration should use the patch. Approved by the U.S. Food and Drug Administration (FDA) in 1990, Duragesic releases fentanyl, a strong opioid, through the skin at a fixed rate for 72 hours. The patch is available only by prescription

Extended use of the Duragesic patch can lead to an addiction or dependence, both physiological and psychological, to fentanyl.

Important Warning

Fentanyl skin patches may cause serious or life-threatening breathing difficulties, which can cause death, especially if not used properly. Fentanyl skin patches should be used only for chronic (around the clock, long-lasting) pain that cannot be controlled by the use of other shorter-acting pain medications that are not as strong. Fentanyl skin patches should not be used to treat short-term pain or pain after an operation or medical or dental procedure. Fentanyl is not for occasional (as needed) use. Fentanyl should be used only for people who have already received narcotic (opiate) pain medication for at least a week and are narcotic tolerant. If you are unsure if you are narcotic-tolerant, ask your doctor. Tell your doctor if you have or have ever had breathing difficulties, chronic obstructive pulmonary disease (COPD), or other lung disease. Tell your doctor and pharmacist if you are taking or plan to take any of the following medications or those listed in SPECIAL PRECAUTIONS: amiodarone (Cordarone, Pacerone); certain antifungals such as fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Nizoral), and voriconazole (Vfend); aprepitant (Emend); cimetidine (Tagamet); clarithromycin (Biaxin, in Prevpac); cyclosporine (Neoral, Sandimmune); delavirdine (Rescriptor); diltiazem (Cardizem, Dilacor, Tiazac, others); efavirenz (Sustiva); erythromycin (E.E.S., E-Mycin, Erythrocin); fluoxetine (Prozac, Sarafem); fluvoxamine (Luvox); HIV protease inhibitors including atazanavir (Reyataz), indinavir (Crixivan), lopinavir (Kaletra), nelfinavir (Viracept), ritonavir (Norvir, in Kaletra), and saquinavir (Fortovase, Invirase); hormonal contraceptives (birth control pills, rings, and patches); lovastatin (Advicor, Altocor, Mevacor); nefazodone; sertraline (Zoloft); troleandomycin (TAO); verapamil (Calan, Covera, Isoptin, Verelan); and zafirlukast (Accolate). If you have any of the following symptoms, call your doctor immediately: difficulty breathing; extreme drowsiness with slow breathing; difficulty thinking, talking, or walking normally; dizziness; confusion; extreme tiredness; fainting; or loss of consciousness.Fentanyl skin patches are for use only on skin that is not irritated, broken out, burned, cut, or damaged in any way. Do not use a fentanyl skin patch that is cut, damaged, or changed in any way, as this can cause you to receive too much medication, which could cause death.Fentanyl skin patches can be habit-forming. Tell your doctor if you or your family drink or have ever drunk large amounts of alcohol; have overused opiate (narcotic) pain medications, have used street drugs, or have or have ever had depression or mental illness. Call your doctor if you begin to use more medication than you have been prescribed, or if you begin ‘craving’ this medication.Fentanyl skin patches contain a large amount of opiate (narcotic) pain medication. Fentanyl may be used by people who misuse or abuse prescription medications or street drugs. Do not let anyone else use your medication. Keep this medication in a safe place to protect it from theft. Selling or giving away this medication is against the law.Fentanyl skin patches should not be used in children less than 2 years of ageand should be used for children only if they are narcotic-tolerant and 2 years of age or older.Talk to your doctor about the risks of using this medication.

Why is this medication prescribed?
Fentanyl skin patches are used to relieve moderate to severe pain that occurs constantly. Fentanyl skin patches contain fentanyl inside.The medication is released from the patch continuously over a period of time and is absorbed through the skin into the bloodstream. Fentanyl is in a class of medications called opiate (narcotic) analgesics. It works to treat pain by changing the way the brain and nervous system respond to pain.

How should this medicine be used?
Fentanyl skin patches are placed on the skin. The patch usually is changed every 3 days. Change your patch at about the same time of day on the days you are supposed to change the patch. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Apply fentanyl patches exactly as directed. Read the patient information that is given to you with your prescription before you start using fentanyl skin patches.

Your doctor may start you on a low dose of fentanyl skin patches and gradually increase your dose, not more often than once every 3 days after the first patch and every 6 days thereafter, based upon your level of pain control. If your pain is not controlled by this medication, call your doctor.

Fentanyl skin patches should never be placed in the mouth, chewed, or swallowed, or used in any way other than directed by your doctor or pharmacist. Do not try to open the patch or allow someone to have your patch (new or used) for this purpose. If the fentanyl gel leaks from the patch at any time, try not
to touch the gel as you remove and throw away the patch according to the directions below. If you or a caregiver touch the gel, immediately wash the area with only large amounts of water. Using soap, alcohol, or other cleansers to remove the gel may actually increase the amount of medication that goes through the skin.

Accidental exposure to the medication inside the fentanyl skin patch can cause serious harm. This may occur through transfer of a patch from an adult’s body to a child while hugging, accidentally sitting on a patch, accidental exposure of a caregiver’s skin to the medication in the patch when applying or removing a patch, or in other ways. If the patch comes off the person for whom it was prescribed and sticks to the skin of another person, take the patch off that person right away, wash the area with water only, and seek immediate medical attention. by calling your doctor, emergency room, or the poison control center. Accidental exposure of children to fentanyl skin patches is a medical emergency. It is important to store and handle this medication carefully to prevent accidental exposure to fentanyl skin patches.

Do not apply more than one patch at a time unless your doctor tells you to, and do not apply fentanyl skin patches more often, or for a longer period of time than your doctor tells you to. Do not stop using fentanyl skin patches without talking to your doctor. Your doctor will probably decrease your dose gradually when you are to stop using this medication. If you suddenly stop using fentanyl skin patches or use the patches less often than your doctor told you to, you may have symptoms of withdrawal. Call your doctor if you experience any of these symptoms of withdrawal: restlessness, tearing from your eyes, runny nose, yawning, sweating, chills, feeling that your hair stands on end, muscle aches, large pupils (black circles in the center of the eyes), irritability, anxiety, backache, pain in the joints, weakness, stomach cramps, difficulty falling asleep or staying asleep, upset stomach, loss of appetite, vomiting, diarrhea, fast heartbeat or rapid breathing.

To apply the patch, follow the directions provided by the manufacturer and these steps:

  • Select a clean, dry area of skin on your chest, back, upper arm, or side above the waist. You should choose an area of your body which is flat and hairless. Avoid areas that move a lot, areas where the skin is sensitive, an area of the skin that has been exposed to radiation (X-ray treatment); or an area where you have recently applied a skin patch. If the area is hairy, clip hair as close to the skin as possible with scissors, but do not shave it.
  • Clean the skin area, using only clear water. Pat the skin completely dry. Do not put anything on the skin (including soap, lotion, alcohol, or oil) before applying the patch.
  • Tear open the pouch containing the fentanyl skin patch along the dotted line, starting at the slit. Remove the skin patch from the pouch and peel off the protective liner from the back of the patch exposing the adhesive (sticky) surface. Try not to touch the sticky side.
  • Immediately press the adhesive side of the patch onto the skin with the palm of your hand.
  • Press the patch firmly, for at least 30 seconds. Be sure that the patch sticks well to your skin, especially around the edges.
  • If the patch does not stick well or comes loose after it is applied, tape the edges down to your skin with first aid tape.
  • When you are finished applying the patch, wash your hands promptly with only clear water.
  • Apply each new patch to a different skin area to avoid irritation. Remove the old patch before applying another one.
  • Fold used patches in half with the sticky sides together and flush down a toilet. Used patches may still contain some medication and may be dangerous to children, pets, or adults who have not been prescribed fentanyl skin patches.
  • If a patch accidentally comes off or if the skin under the patch becomes irritated, remove the patch and replace it with a new one in a different area, following the steps above.
  • Do not remove a skin patch from its protective pouch or remove the protective backing until just before applying it. Do not use a patch if the pouch or backing has been broken or damaged.
  • If fentanyl has been prescribed for a person who is unable to think well or for a child, the patch should be placed on his or her upper back so it is less likely that the patch could be removed and put in their mouth.

Other uses for this medicine
This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

What special precautions should I follow before using fentanyl skin patches?

  • tell your doctor and pharmacist if you are allergic to fentanyl, other opiate (narcotic) pain medications, adhesives (glues), any other medications, or any of the ingredients in fentanyl skin patches. Ask your pharmacist for a list of the ingredients.
  • tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, and nutritional supplements you are taking or plan to take. Be sure to mention the medications listed in the IMPORTANT WARNING and any of the following medications: antidepressants; antihistamines; carbamazepine (Carbatrol, Epitol, Tegretol); dexamethasone (Decadron, Dexpak); griseofulvin (Fulvicin, Grifulvin, Gris-PEG); medications for anxiety; medications for cough, cold, or allergies; medications for upset stomach; muscle relaxants; nevirapine (Viramune); other medications for pain; phenobarbital; sedatives; sleeping pills; phenytoin (Dilantin, Phenytek); rifabutin (Mycobutin); rifampin (Rifadin, Rimactane, in Rifamate); or tranquilizers. Also tell your doctor or pharmacist if you are taking the following medications or have stopped taking them within the past 2 weeks: monoamine oxidase (MAO) inhibitors including furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), procarbazine (Matulane), selegiline (Carbex, Eldepryl), and tranylcypromine (Parnate). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
  • tell your doctor what herbal products you are taking, especially St. John’s wort.
  • tell your doctor if you have or have ever had a head injury, a brain tumor, a stroke or any other condition that caused high pressure inside your skull; seizures; irregular heartbeat; prostate problems or any other condition that causes difficulty urinating; Addison’s disease (a condition in which the adrenal gland does not make enough of certain natural substances); gallbladder disease; low blood pressure; paralytic ileus or any other problem which causes blockage of the intestines;or thyroid, heart, liver, or kidney disease.
  • tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using a fentanyl skin patch, call your doctor. Do not use fentanyl skin patches if you are breast-feeding.
  • if you are having surgery, including dental surgery, tell the doctor or dentist that you are using fentanyl skin patches.
    you should know that this drug may make you drowsy. Do not drive a car, operate
    machinery, or do other possibly dangerous activities until you know how this drug affects you.
  • you should know that fentanyl skin patches may cause dizziness, lightheadedness, and fainting when you get up too quickly from a lying position. This is more common when you first start using fentanyl skin patches. To avoid this problem, get out of bed slowly, resting your feet on the floor for a few minutes before standing up.
  • remember that alcohol can add to the drowsiness caused by this medication. Do not drink any alcohol while using fentanyl skin patches. You should know that fentanyl skin patches may cause constipation (less frequent than usual or hard bowel movements). Talk to your doctor about the use of laxatives or stool softeners to prevent or treat constipation while you are using fentanyl skin patches.
  • keep in mind that you should not expose a fentanyl skin patch to direct heat or sunlight, heating pads, electric blankets, sun lamps or tanning beds, hot tubs, saunas, heated water beds, or other heat sources. Heat may increase the amount of fentanyl you receive from the skin patch.you should know that if you have a fever the amount of fentanyl that you receive from the skin patch may increase significantly and possibly result in an overdosage of medication. The amount of fentanyl that you receive from the skin patch may increase significantly and possibly result in an overdosage of medication. Call your doctor right away if you have a fever higher than 102 °F. Your doctor may need to adjust your dose.

What special dietary instructions should I follow?
Talk to your doctor about eating grapefruit and drinking grapefruit juice while using this medication.

What should I do if I forget a dose?
If you forget to apply or change a fentanyl skin patch, apply the patch as soon as you remember it. Be sure to remove a used patch before applying a new patch. Leave the new patch on for the regular period of time prescribed by your doctor (usually 3 days) and then replace it. Do not wear two patches at once unless your doctor has told you to.

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

What storage conditions are needed for this medicine?
Keep this medication in the protective pouch it came in, tightly closed, and out of reach of children and pets. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Do not store fentanyl skin patches inside your car.

Throw away any medication that is outdated or no longer needed by carefully removing the adhesive backing, folding the sticky sides of the patch together (until it sticks to itself), and flushing the patch down the toilet. Throw away the pouch and protective liner in the trash. Wash your hands well with water after throwing away fentanyl patches. Do not put used fentanyl skin patches in a garbage can. Used fentanyl patches still contain some medication after they are removed from the skin.

Store fentanyl skin patches in a safe place so that no one can take it accidentally or on purpose. Keep track of how many patches are left so you will know if any are missing.

In case of emergency/overdose
In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services
at 911.

  • Symptoms of overdose may include:
  • difficulty breathing
  • extreme sleepiness or tiredness
  • difficulty thinking, talking, or walking normally
  • small, pinpoint pupils (black circles in the center of the eye)
  • faintness
  • dizziness
  • confusion
  • coma

What other information should I know?
Keep all appointments with your doctor.

You may bathe, shower, and swim while wearing a fentanyl skin patch.

This prescription is not refillable. Be sure to schedule appointments with your doctor on a regular basis so that you do not run out of medication if your doctor wants you to continue using fentanyl skin patches.

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