What is Duragesic?

Duragesic (fentanyl transdermal system) is a skin patch that belongs to a group of medicines called narcotic analgesics or opioid analgesics. Narcotic analgesics are used to relieve pain. Duragesic's skin patch form is used to treat around-the-clock pain (chronic pain) that is moderate to severe, and expected to last for weeks or longer.

The Duragesic CII Patch is manufactured by ALZA Corporation and distributed by Janssen Pharmaceutica Products, L.P. Duragesic was first approved by the U.S. Food and Drug Administration (FDA) in 1990.

Fentanyl Patches Recalled

On February 12, 2008, painkiller patches containing the prescription medication fentanyl were recalled, because a cut in the patch's drug reservoir may cause a harmful overdose of the potent painkiller. The affected patches are sold by PriCara under the Duragesic brand name. A generic version of the fentanyl patches is marketed by Sandoz Inc. The recall applies to all 25 microgram/hour fentanyl patches (brand name and generic) with expiration dates on or before December 2009. The recalled patches should be discarded immediately. PriCara is advising patients with recalled 25 mcg/hr Duragesic patches to call 800-547-6446, while patients with recalled 25 mcg/hr Sandoz Inc. should call 800-901-7236.

Duragesic FDA Alert - Narcotic Overdose and Death

In July 2005, the FDA issued an alert stating that it is looking into reports of death and other serious side effects from overdoses of the narcotic fentanyl in patients using Duragesic skin patches for pain control.

Directions for using the Duragesic skin patch must be followed exactly to prevent death or other severe side effects that can happen from using too much (overdosing) fentanyl. These directions are provided in the patient package insert [PDF] from the FDA.

What Should I Know Before Using Duragesic?

Duragesic should not be the first narcotic pain medicine that is prescribed for your pain. You should only use Duragesic if you have been taking at least 60 milligrams (mg) of oral morphine daily, or at least 30 mg of oral oxycodone daily, or at least 8 mg of oral hydromorphone daily, or an equally strong dose of another narcotic analgesic for a week or longer before starting Duragesic.

Duragesic is not for patients who need narcotic pain medicines for only a short time. This includes pain associated with surgery (such as tonsillectomies), and medical or dental procedures (such as wisdom tooth removal).

Duragesic is not for occasional ("as needed") use.

Duragesic is only for opioid-tolerant children who are two years of age or older, and who are already using other opioid narcotic pain medicines. Pediatric patients two years of age or older are opioid tolerant if they are taking at least 60 milligrams (mg) of oral morphine daily, or at least 30 mg of oral oxycodone daily, or at least 8 mg of oral hydromorphone daily, or an equally strong dose of another opioid for a week or longer before starting Duragesic.

Who Should Not Use Duragesic?

You should not use Duragesic if you:

• are not already using other opioid narcotic medicines
• need opioid (narcotic) pain medicines for only a short time
• need treatment for pain from surgery, medical or dental procedures
• have pain that can be taken care of by occasional use of other pain medicines
• have acute (sudden) or severe asthma
• have a gastrointestinal problem called paralytic ileus

Children less than two years of age and children two years of age or older not already using other opioid narcotic pain medicines (opioid tolerant) should not use Duragesic.

Duragesic Health Risks

There are serious health risks associated with Duragesic use. Call your healthcare professional right away or get emergency medical help if you:

• have trouble breathing
• experience extreme drowsiness with slowed breathing
• experience shortness of breath (little chest movement with breathing)
• Feel faint, dizzy, confused, or have other unusual symptoms.

These can be symptoms related to Duragesic overdose. These symptoms may lead to serious problems or death if not treated right away. Also, stopping the Duragesic skin patch suddenly can make you sick with withdrawal symptoms. Talk to your healthcare professional about slowly stopping Duragesic.

There is a chance you could get addicted to the Duragesic skin patch. The chance is higher if you are or have been addicted to or abused other medicines, street drugs, or alcohol, or if you have a history of mental problems.

Duragesic users may also experience a drop in blood pressure. This can make you feel dizzy if you get up too fast from sitting or lying down.

Duragesic Side Effects

Common side effects associated with Duragesic use include:

• nausea
• vomiting
• constipation
• dry mouth
• sleepiness
• confusion
• weakness
• sweating

Constipation is a very common side effect of opioids, including the Duragesic skin patch, and is unlikely to go away without treatment. Talk to your healthcare professional about the use of laxatives (medicines to treat constipation) and stool softeners to prevent or treat constipation while using Duragesic.

The Duragesic skin patch can make you sleepy. Do not drive, operate heavy machinery, or do any other possibly dangerous activities until you know how Duragesic affects you.

Although uncommon, trouble sleeping and seizures were reported in children.

What Should I Tell My Healthcare Professional?

Before using Duragesic, you should tell your healthcare professional about all of your medical problems, especially if you:

• have trouble breathing or lung problems such as asthma, wheezing, or shortness of breath
• have a head injury or brain problems
• have a heart problem called bradycardia (slow heart beat)
• have liver or kidney problems
• have seizures (convulsions or fits)
• have gallbladder problems
• have low thyroid (hypothyroidism)
• have low blood pressure
• have problems urinating
• have major depression
• experience hallucinations (seeing or hearing things that are not seen by other people)
• have adrenal gland problems such as Addison's disease
• have a past or present drinking problem or alcoholism, or a family history of this problem
• have a past or present drug abuse or addiction problem, or a family history of this problem
• have skin reactions to the adhesives (glues) used in the Duragesic skin patch
• Are pregnant or planning to become pregnant. The Duragesic skin patch may harm your unborn baby.
• Are breast feeding. The medicine in the Duragesic skin patch passes into your milk and can harm your baby.
• Use heating sources such as heating pads, electric blankets, heat lamps, saunas, hot tubs, or heated waterbeds. Do not take long hot baths or sun bathe. All of these can make your temperature rise and cause too much of the medicine in the Duragesic skin patch to be released at once and this can be dangerous.

Can Other Medicines or Foods Affect the Duragesic Skin Patch?

The Duragesic skin patch and certain other medicines can interact with each other. Tell your healthcare professional about all the medicines you take - including prescription and non-prescription medicines, vitamins, and herbal supplements - especially other medicines that make you sleepy such as:

• Other pain medicines
• Sleeping pills
• Anxiety medicines
• Antihistamines
• Tranquilizers

Do not start any new prescription medicine, non-prescription medicine, or herbal supplement while using the Duragesic skin patch until you have talked to your healthcare professional.

What Else Should I know About the Duragesic Skin Patch?

Call your healthcare professional right away if you get a fever higher than 102ºF. A fever may cause an overdose of the medicine in the Duragesic skin patch. Your healthcare professional may tell you to use a lower dose while you have a fever.

Do not use the Duragesic skin patch if the seal is broken or the patch is cut, damaged or changed in any way. Using a patch that is cut, damaged, or changed in any way can expose you to the contents of the patch, which contains a potentially fatal dose of medicine.

Do not change your dose or stop using the Duragesic skin patch unless your healthcare professional tells you to.

Do not use the Duragesic skin patch more often than prescribed.

Do not wear more than one Duragesic skin patch at a time, unless your healthcare professional tells you to do so.

After you have stopped using a patch, be sure to fold the sticky sides of the patch together and flush it down the toilet. Do not put used Duragesic skin patches in a garbage can.

If your healthcare professional tells you to stop using the Duragesic skin patch, throw away the unused packages. Open the unused packages and fold the sticky sides of the patches together, and flush them down the toilet.

Duragesic - Getting Legal Help

While all medications have certain anticipated side effects, a drug manufacturer has a duty to make its products as reasonably safe as possible, and to inform the medical community and the public of known risks associated with its drugs. If a manufacturer fails to do so, it can be held legally responsible if patients are injured as the result of inadequate warnings or the unreasonably dangerous nature of the drug, under a legal theory called "product liability."

If you or a loved one have experienced any dangerous symptoms or unusual medical conditions while using Duragesic, you should first contact your doctor or other healthcare professional. You may also wish to meet with an experienced attorney to discuss your options and to protect your right to a legal remedy for any injuries caused by Duragesic use.

• Go here to learn more about an attorney's role in a pharmaceutical liability case.
• To find an experienced attorney, use the "Find a Lawyer" tool on the left side of this page, or click here.