Duragesic Patch - FindLaw
Created by FindLaw's team of legal writers and editors| Last reviewed December 21, 2016
Duragesic is a brand name for the narcotic pain medicine fentanyl. The Duragesic patch is an adhesive patch containing narcotic pain medicine - typically narcotic analgesics or opioid analgesics. Duragesic is used to treat moderate to severe chronic, constant pain that is expected to last for several weeks or longer. The ALZA Corporation manufactures Duragesic, which was first approved by the U.S. Food and Drug Administration (FDA) in 1990.
Faulty Fentanyl Patches Recalled
On February 12, 2008, fentanyl painkiller patches like Duragesic were recalled when it was discovered that a cut in the patch's drug reservoir could cause a harmful overdose. The recall applied to all 25 microgram/hour fentanyl patches (brand name and generic) with expiration dates on or before December 2009. If you have one of these patches in your possession, it should be discarded immediately.
FDA Alert Regarding Overdose and Death from Improper Use of Duragesic
In July 2005, the FDA issued an alert stating it was investigating reports of death and other serious side effects from overdoses of fentanyl from Duragesic skin patches and stressed that the directions for use of the patch must be followed exactly, or an accidental overdose can occur. Directions are provided in the Duragesic patient package insert. In September 2013, the FDA required manufacturers to alter the labeling on Duragesic patches to minimize the risk of accidental harmful exposure.
What Should I Know Before Using Duragesic?
Duragesic is not for patients who need narcotic pain medicines for only a short time. You should only use Duragesic if you have already been taking one of the following:
- At least 60 milligrams of oral morphine daily
- At least 30 mg of oral oxycodone daily
- At least 8 mg of oral hydromorphone daily
- An equally strong dose of another narcotic analgesic for a week or longer
Who Should Not Use Duragesic?
You shouldn’t 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
Duragesic Health Risks
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 and may lead to serious problems or death if not treated right away.
Addiction and Withdrawal
Patients can get addicted to the patch. Addiction is more likely if you have been addicted to or abused other medicines, street drugs, or alcohol, or if you have a history of mental health issues. Stopping the Duragesic skin patch suddenly can make you sick and experience withdrawal symptoms.
Sudden Loss of Blood Pressure
Duragesic users may also experience a drop in blood pressure and feel dizzy after getting up too fast after sitting or lying down.
Duragesic Side Effects
Common side effects associated with Duragesic use include:
- Dry mouth
Constipation is a very common side effect of opioids and is unlikely to go away without treatment. Talk to your healthcare professional about the use of laxatives and stool softeners to treat constipation. The Duragesic skin patch can also make you sleepy so you should not drive, operate heavy machinery, or perform any dangerous activities until you know how Duragesic affects you.
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
- A head injury or brain problems
- Heart, liver, gallbladder or kidney problems
- Low blood pressure
- Problems urinating
- Major depression
- Adrenal gland problems
- A past or present drug abuse, addiction, or drinking problem, or a family history of any of these problems
- Skin reactions to adhesives
Also, if you are pregnant or planning to become pregnant, the Duragesic skin patch may harm your unborn baby. Nursing can also be harmful to the baby because the narcotics from the patch can pass from you to your baby.
Can Other Medicines or Foods Affect the Duragesic Skin Patch?
The Duragesic skin patch and other medicines can react with each other, so tell your healthcare professional about all the medicines you take - including vitamins and herbal supplements. Take special care to notify your doctor about medicines that make you sleepy like sleeping pills, anxiety medicines, antihistamines, other painkillers, and tranquilizers.
What Else Should I Know About the Duragesic Skin Patch?
When using the patch, you should be cautious not to cause a significant rise in your body temperature, because the narcotics in the patch will release more quickly. Do not sunbathe or take long hot baths, and do not use heating sources such as heating pads, electric blankets, heat lamps, saunas, hot tubs, or heated waterbeds. A fever can also cause an overdose of the medicine, so call your doctor right away if you experience a fever higher than 102ºF.
Never use the Duragesic patch if the seal on the packaging is broken or the patch is cut, damaged or altered in any way. Using a damaged patch can expose you to a potentially fatal dose of narcotics. Do not wear more than one patch at a time, and do not use the patch more often than prescribed. Be sure to securely discard of the patch by pressing the sticky sides of the patch together and flushing it down the toilet.
Duragesic - Getting Legal Help
While all medications have certain anticipated side effects, drug manufacturers have a duty to make their products as reasonably safe as possible, and to inform the medical community and the public of known risks associated with their drugs. If a manufacturer fails to do so, it can be held legally responsible for resulting injuries under a legal theory called "product liability."
If you or a loved one has experienced any unusual symptoms or 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 an attorney experienced in products liability or medical malpractice to discuss your legal options.