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: