Wednesday, November 23, 2005

Beware of Duragesic Pain Patch Use

Duragesic Pain Patch Issues
The Duragesic patch is indicated for the management of severe, chronic pain (such as cancer pain) that cannot be managed with less powerful drugs such as acetaminophen-opioid combinations and nonsteroidal analgesics. Moreover, only patients who are already on and tolerant to opioid therapy, and who require continuous opioid administration should use the patch.

Approved by the U.S. Food and Drug Administration (FDA) in 1990, Duragesic releases fentanyl, a strong opioid, through the skin at a fixed rate for 72 hours. The patch is made by Janssen Pharmaceutica and available by prescription only.

A boxed warning indicates that Duragesic is not to be used in the following circumstances: to manage acute or postoperative pain, including pain after outpatient surgery for mild or intermittent chronic pain that can be managed with less powerful drugs at a dose higher than 25 micrograms per hour by children under age 12 by patients under age 18 who weigh less than 110 lbs. Side effects include, but may not be limited to, nausea, vomiting, constipation, drowsiness, weakness, dry mouth, hypotension and loss of appetite. Users are warned to avoid exposure to external heat sources such as heating pads and electric blankets, hot tubs, heated water beds, heat lamps, etc., because of a potential for temperature-dependent increases in fentanyl release that may lead to an overdose.

In February 2004, Janssen and the FDA notified healthcare professionals of a Class I recall of DURAGESIC 75 mcg/h. Only Control Number 0327192 (expiration October 2005) is subject to this recall. A potential seal breach on one edge may allow the drug to leak from the patch and could result in an increased absorption of the opioid component, fentanyl, leading to increased drug effect, including nausea, sedation, drowsiness, or potentially life threatening complications. Conversely, if the hydrogel contents leak out of the patch, there may not be adequate medication to treat the patients' pain. In an opioid tolerant patient, this may lead to withdrawal symptoms, which include sweating, sleeplessness and abdominal discomfort. Over 400,000 patches are included in the recall.

In April 2004, Janssen expanded the Duragesic patch recall to include a total of 2.2 million patches. Health officials believe that over 20 percent of the recalled patches are still in use.In July 2005, the FDA issued a Public Health Advisory regarding the safe use of transdermal fentanyl patches in response to reports of deaths in patients using this potent narcotic medication for pain management. In addition, a patient information sheet and an alert to healthcare professionals were issued identifying several important safety precautions for the use of fentanyl transdermal patches. These safety precautions include but are not limited to patient education regarding signs of overdose, proper patch application, use of other medications while using the patch, safeguards for children, and proper storage and disposal.

The FDA is conducting an investigation into the deaths associated with these patches. The Agency has been examining the circumstances of product use to determine if the reported adverse events may be related to inappropriate use of the patch or factors related to the quality of the product. It is possible that some patients and their health care providers may not be completely aware of the dangers of these potent narcotic drug products and the important recommendations regarding their safe use.The Agency is working closely with the manufacturers of fentanyl patches to fully evaluate the risks associated with their use and to develop a plan to help patients avoid accidental fentanyl overdose.

See your doctor if you suffered an adverse side effect while using the Duragesic patch. In addition, it may be important to contact an attorney who can help you protect your legal rights. Please keep in mind that there may be time limits within which you must commence suit.

Duragesic Lawsuit

On Apr-05-04, Janssen Pharmaceutical Products LP issued an urgent recall for defective patches. The recall applies only to specific manufacturing lots of the 75mcg strength patches, which have a faulty seal that permits full strength fentanyl to leak from the patch. This could result in patients being given an overdose of fentanyl, which can cause fatal respiratory and/or cardiac arrest.

Only the following lot numbers are affected:NDC no. 50458-035-05Lot Control nos. 0327192, 0327193, 0327294, 0327295, and 0330362

Symptoms of Overdose Symptoms of a fentanyl overdose include slow breathing, seizures, dizziness, weakness, loss of consciousness or coma, confusion, tiredness, cold and clammy skin, and small pupils. Continued exposure to uncontrolled amounts of fentanyl can lead to addiction and dependency.

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