Duragesic Fentanyl Patch

NEWS: February 13, 2008

Johnson & Johnson Duragesic Pain Patch Flaw Recall.
A recall has been issued by Johnson & Johnson and Novartis AG's Sandoz on 25-microgram-per-hour patches with expiration dates on or before December 2009.

It was found that a manufacturing problem led to some of the patches having a cut in the internal reservoir lining. This cut may cause a leaking problem of the patch. The danger is if anyone touches a defective pain patch they may be delivered a dose of the prescription painkiller fentanyl which may lead to breathing problems or even an accidental overdose.

Back in December the FDA issued a safety warning on the Duragesic patch, citing improper use may cause breathing difficulties and death. The FDA continues to work with J& J on this voluntary recall and is investigating this latest issue.

The purpose of the Duragesic Fentanyl patch is to relieve severe chronic pain, such as for sufferers of rheumatoid arthritis. The patch is only available with a prescription and can provide long-lasting relief for pain. The patch works by delivering Fentanyl into the body through the skin. One patch relieves pain for up to 72 hours. The patch should only be used when less potent drugs have not worked in the past. The patch can also be used if pain needs to be managed around the clock.

There is a boxed warning that patients should read before taking the Duragesic Fentanyl patch. The patch contains a high concentration of Schedule II opioid agonist; other drugs that belong to this family include morphine, oxycodine, and methadone. Users of these drugs have a high instance of abuse and risk overdosing causing death. Due to the high content of Fentanyl in the Duragesic Fentanyl patch, there is a high risk of abuse.

You should not use the Duragesic Fentanyl patch if you are not opioid-tolerant. Other indications that you should not use the patch are if you only require pain management for a short period of time, if you are managing post-operative pain, and if your pain is mild or intermittent.

Patients should only use the patch if they have already developed a tolerance to opioid drugs meaning they have been taking at least 60mg of morphine or the equivalent for over a week. The Duragesic Fentanyl patch should only be used if the patient needs a high dosage of pain medication around the clock for an extended period of time.

Some known side effects of the use of the patch include nausea, vomiting, sleepiness, constipation, and sweating. Combining the Duragesic Fentanyl patch with alcohol or sleep medications may be addictive or result in death. Using the patch will also impair the patients' ability to drive or operate machinery.

Patients should also be careful not to expose the Duragesic Fentanyl patch to heat sources including saunas, hot tubs, and heated waterbeds. The result may be an increase in the amount of Fentanyl being released into the body. This could result in an overdose potentially leading to death.

When applying the Duragesic Fentanyl patch to the body it should be folded so that the adhesive side adheres to itself. When removing the patch after use it should be flushed down the toilet immediately to prevent misuse.

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Duragesic Fentanyl Patch Recall News

The FDA issued a Public Health Advisory on July 15, 2005 in regard to the safety of the Duragesic Fentanyl patch. The advisory will stand while the FDA investigates 120 deaths that have been linked to using the patch. The intended use for the patch was continuous and intense pain relief.

The advisory was implemented after hearing several health professionals voice their concerns regarding the deaths of patients after improper usage. The FDA has also issued a patient information sheet be distributed outlining safety precautions that must be taken in order to prevent an overdose from occurring. Some of the topics outlined on this information sheet include how to properly apply the Duragesic Fentanyl patch, how to recognize signs of an overdose, and how to properly store and dispose of the patch.

It was stated that several of the deaths relating to the patch may have occurred due to an accidental overdose. According to the FDA, the Duragesic Fentanyl patch must be used according to strict directions in order to prevent death and overdosing. This suggests that patients are not heeding the warning labels on the box for the patch.

Ideally, the Duragesic Fentanyl patch should only be used as an alternative to morphine, if a patient develops a morphine tolerance. The patch is also quite a bit more expensive than morphine and it is also easier to accidentally overdose while using the patch.

Signs of an overdose while using the Duragesic Fentanyl patch include: trouble breathing, extreme sleepiness, inability to think, walk and talk, feeling dizzy and confused. Patients who experience these symptoms must take them seriously and contact their physician or caregiver immediately.

The FDA has also warned that the Duragesic Fentanyl patch should only be prescribed at the lowest possible dose to manage the pain, anything higher could result in overdose or a dependence on the pain killer. The Duragesic Fentanyl patch should only be used to treat patients who have already taken narcotic painkillers and find that short-action pain killers to do completely relieve their pain. A generic version of the patch was also released into the marketplace and subsequently was also responsible for deaths among patients.

Due to the numerous deaths related to the Duragesic Fentanyl patch if you have suffered from using the patch it is advised that you receive a free legal evaluation regarding your situation. You should also cease from taking the patch immediately upon experiencing side effects of overdose and seek medical help.