Q: What is Duragesic?
A: 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.
Q: Has there been any recent news about Duragesic?
A: 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.
In September 2013, the FDA required ALZA to alter the labeling on Duragesic patches to minimize the risk of accidental exposure. The FDA mandated that the revised label clearly print the name and strength of the drug in long-lasting ink. This makes the patch easily distinguishable, whether it is still on a body or it has fallen off. Patients should be aware that the patch can fall off and may stick to someone in close contact such as a child. Duragesic patches need to be properly disposed after use. For example, folded and then flushed down the toilet.
Q: What should I know before using Duragesic?
A: Duragesic should not be the first narcotic pain medicine that is prescribed for your pain. Duragesic is not for patients who need narcotic pain medicines for only a short time and not for occasional ("as needed") use.
Q: Can children use Duragesic?
A: 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.
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.
Q: Who should not use Duragesic?
A: You should not use Duragesic if you are not already using other opioid narcotic medicines; if you need opioid pain medicines for only a short time; if you need treatment for pain from surgery, medical or dental procedures; if you have pain that can be taken care of by occasional use of other pain medicines; if you have acute (sudden) or severe asthma; or if you have a gastrointestinal problem called paralytic ileus.
Q: Are there any serious health risks associated with Duragesic use?
A: There are serious health risks associated with Duragesic use. You should call your healthcare professional immediately or get emergency medical help if you have trouble breathing, experience extreme drowsiness with slowed breathing, experience shortness of breath, or feel faint, dizzy, confused, or have other unusual symptoms. These can be symptoms related to Duragesic overdose and can 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.
Q: What are the side effects associated with Duragesic?
A: Common side effects associated with Duragesic use include nausea, vomiting, constipation, dry mouth, sleepiness, confusion, weakness, and sweating. Although uncommon, trouble sleeping and seizures were reported in children.
Q: What should I tell my healthcare professional before he or she prescribes Duragesic?
A: Before you use Duragesic, tell your healthcare professional about all 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; have gallbladder problems; have low thyroid (hypothyroidism); have low blood pressure; have problems urinating; have major depression; experience hallucinations; 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 used in the Duragesic skin patch; are pregnant or planning to become pregnant; are breast feeding; use heating sources such as heating pads, electric blankets, heat lamps, saunas, hot tubs, or heated waterbeds.
Q: Are there any interactions between Duragesic and other drugs or foods?
A: 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 (e.g. other pain medicines, sleeping pills, anxiety medicines, antihistamines, or 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.
Q: What else do I need to know about using Duragesic?
A: Call your healthcare professional right away if you get a fever higher than 102ºF. Do not use the Duragesic skin patch if the seal is broken or the patch is cut, damaged or changed in any way. Do not change your dose, wear more than one Duragesic skin patch at a time, stop using the Duragesic skin patch, or use the skin patch more often than prescribed, unless your healthcare professional tells you to. Dispose of used and unused Duragesic skin patches properly according to the manufacturer's or your healthcare professional's instructions.
Q: What should I do if I think I have been injured as a result of using Duragesic?
A: 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. It may also be in your best interests to meet with a product liability attorney to discuss your options and to protect your right to a legal remedy for any injuries caused by Duragesic use.
Contact a qualified product liability attorney to make sure your rights are protected.