Duragesic Fentanyl Patch

Modified on 2009/10/14 21:53 by admin
duragesic patch 75mcg

duragesic patch 75mcg

Fentanyl Patch                    Source: FDA
Duragesic Package Insert 

The Duragesic patch is indicated for the management of severe, chronic pain (such as cancer pain) that cannot be managed with less powerful opioid analgesics. Only patients who are already tolerant to opioid therapy and who require continuous opioid administration should use the pain 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.

Duragesic Advisory Information

Duragesic's black box warning advises that the drug should not be used to manage acute postoperative pain, including pain after outpatient surgery, or 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, or by patients under age 18 who weigh less than 110 lbs.  Do not use fentanyl patches in concert with other opioid analgesics, such as oxycodone (OxyContin) or oxymorphone (Roxicet, Numorphan).

The FDA is conducting an investigation into the deaths associated with fentanyl transdermal 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.

Side effects of the Duragesic patch  include 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.

Duragesic History

February 2008

In February 2008, Johnson & Johnson issued a recall of all lots of Duragesic CII 25mcg patches.  The patches may have a cut edge that could lead to the fentanyl gel leaking out and potential for overdose.  The recalled fentanyl patches were sold by Sandoz and Pricara in the U.S. and Canada.  None of the other Duragesic patch strengths (12.5, 50, 75, and 100mcg patches) were affected in the recall.

September 2007

 In 2007, the Institute for Safe Medication Practices and the Division of Public Health Sciences, Wake Forest University School of Medicine, conducted a longitudinal Adverse Events Reporting System Review of the U.S. FDA's most dangerous drugs. The study revealed fentanyl to be the second most dangerous drug available on the market with the second highest number of suspect drug deaths.  Over the eight years of the study, fentanyl was involved in no fewer than 3,500 suspect drug deaths during the 8-year period.

July 2005

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.

April 2004

In April 2004, Janssen expanded a Duragesic patch recall to include a total of 2.2 million patches. Health officials believed at the time that over 20 percent of the recalled patches are still in use.

February 2004

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) was 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, and potentially life threatening complications. Over 400,000 patches were included in the initial recall.

The FDA 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.

Drug Injury

Please consult with your physician about any questions you may have concerning Duragesic use.  If you are experiencing any of the side effects or symptoms associated with fentanyl toxicity, it may be important for you to discuss treatment alternatives to the pain patch. 

If you have legal questions or believe that you have been injured as a result of a Duragesic patch, you should contact an attorney who has experience in this area of practice.

IMPORTANT - You should never stop using any medication without first consulting with your prescribing physician. 

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