Duragesic Fentanyl Patch

News Update 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.

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The Duragesic fentanyl patch is an opioid (narcotic) medication used to treat moderate to severe long-lasting chronic pain. Manufactured by ALZA Corporation and distributed by Janssen Pharmaceutica Products, the patch delivers fentanyl (a pain relieving drug) into the bloodstream slowly through the skin, where it works to relieve pain for up to 3 days (72 hours).

Why Prescribed

The Duragesic fentanyl patch belongs to a group of medicines called narcotic analgesics or opioid analgesics, and is prescribed to provide a continuous delivery of pain medication to a patient with various types of cancer, or after injury.

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FDA Approved Uses

The Duragesic fentanyl patch was approved by the FDA in 1990 to treat around-the-clock pain (chronic pain) that is moderate to severe and expected to last for weeks or longer. Fentanyl is a narcotic, a member of the same group of drugs to which opium and morphine belong.

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Side Effects

Common side effects associated with the Duragesic fentanyl patch include nausea, vomiting, constipation, dry mouth, sleepiness, confusion, weakness, and sweating.

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Warnings and Alerts

The FDA is investigating reports of death and other serious side effects from overdoses of fentanyl in patients using fentanyl transdermal (skin) patches for pain control. The directions for using the Duragesic fentanyl patch must be followed exactly to prevent death or other serious side effects from overdosing with fentanyl.

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Drug Contraindications

The Duragesic fentanyl patch is contraindicated in patients who are not opioid-tolerant, in the management of mild pain, in the management of intermittent pain (e.g., use on an as needed basis), in situations of significant respiratory depression--especially in unmonitored settings where there is a lack of resuscitative equipment, and in patients who have acute or severe bronchial asthma.

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FAQ's

Has the FDA issued a public health advisory for the Duragesic fentanyl patch?

Yes. In 2004, the FDA issued a public health advisory to alert patients and their caregivers and health care professionals about the following important safety information:

• Fentanyl skin patches are very strong narcotic (opioid) painkillers that may cause death from overdose. The fentanyl skin patch should always be prescribed at the lowest dose needed for pain relief.
• Fentanyl skin patches should not be used to treat short-term pain, pain that is not constant, or for pain after an operation. Fentanyl skin patches should only be used by patients who are already taking other narcotic painkillers (opioid tolerant), and who have chronic pain that is not well controlled with shorter-acting painkillers.
• Patients who are using the fentanyl skin patch and their caregivers should be told about the directions for safe use of the patch and should follow the directions exactly.

What are signs of a fentanyl overdose?

Signs of a fentanyl overdose include trouble breathing or shallow breathing, tiredness, extreme sleepiness or sedation, inability to think, talk or walk normally, and feeling faint, dizzy or confused. If these signs occur, patients or their caregivers should seek medical attention immediately.

Who should not use the Duragesic fentanyl patch?

You should not use the Duragesic fentanyl patch 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.

What should I tell my healthcare professional before he or she prescribes the Duragesic fentanyl patch?

Before you use the Duragesic fentanyl patch, 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 low thyroid (hypothyroidism), have low blood pressure, are pregnant or planning to become pregnant, and/or use heating sources such as heating pads, electric blankets, heat lamps, saunas, hot tubs, or heated waterbeds, as these can increase the rate fentanyl enters the bloodstream.

If I have suffered injuries from using the Duragesic fentanyl patch, do I have a right to financial compensation?

Patients injured by defective drug products are ordinarily entitled to recover monetary damages for all losses and expenses suffered from use of the product. Depending upon the particular circumstances of your case, damages may include recovery for any of the following:

• Medical bills
• Lost income, including overtime wages
• Pain & Suffering
• Physical Disability
• Emotional Trauma
• Mental Disability

For more information, contact an experienced defective drug litigation lawyer to discuss your legal claim and the options available to you.

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