Did you know?
Some patches from the recalled lots may leak medication due to improper sealing of one of their edges.
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The Quick Facts on the Duragesic Patch:
- There has been an expanded recall of Duragesic Patches (fentanyl transdermal) due to possible leaks.
- The FDA is investigating 120 deaths of Duragesic Patch users and warned patients to use the powerful narcotic properly to avoid accidental overdose.
- Over 400,000 Duragesic Patches are included in the recall.
- Leakage of the medication could lead to leading to potentially life-threatening complications and and/or opiate withdrawal.
- The patches come in different strengths, and more than one patch may be worn at a time.
- 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.
- Bounty Hunter Domino Harvey , subject of New Line Cinema's 2005 Movie, "Domino" died of an accidental overdose from the powerful painkiller fentanyl. This drug is more powerful than morphine and her death was due to acute fentanyl toxicity.
- 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 available only by prescription.
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
The FDA is working 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.
About the Duragesic Patch
The Duragesic Patch is a pain patch that is worn on the skin as an external treatment for chronic pain. The Duragesic patch contains a narcotic analgesic called fentanyl. 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.
The Duragesic Patch is for the management of severe, chronic 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.
FDA and the Duragesic Patch
On July 15, 2005 the FDA issued a Public Health Advisory warning regarding the use of the Duragesic patch due to recent reports of overdoses and death in those who were using the potent narcotic medication as a pain reliever.
On April 27, 2005 the FDA approved revisions to safety labeling of fentanyl transdermal systems, including Duragesic, that stated the patch is associated with a risk of serious or life-threatening hypoventilation that may occur at any time during the use of the patch.
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
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 Food and Drug Administration is probing whether the deaths are related to inappropriate use of the painkiller or factors related to the product's quality.
FDA reports suggest that some deaths have been accidental overdoses, and some reports suggest that patients or those prescribing the medication were not aware of crucial safety information on the drug's label, said the FDA's Robert Meyer.
The Duragesic Patches affected are from the following lot numbers:
- NDC no. 50458-035-05
- Lot Control #0327192
- Lot Control #0327193
- Lot Control #0327294
- Lot Control #0327295
- Lot Control #0330362
Duragesic Patch Cautions
Side effects include, but may not be limited to:
- Nausea
- Vomiting
- Sweating
- Constipation
- Drowsiness
- Weakness
- Dry mouth
- Hypotension
- Sleeplessness
- Clammy skin
- Small pupils
- Abdominal discomfort
- 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.
Hypoventilation is one of the most common serious adverse side effects. Hypoventilation is breathing that is too shallow or too slow and is therefore not adequate to meet the needs of the body. It also causes reduced lung function. Hypoventilation results in an inadequate oxygen supply getting into the bloodstream due to a rise in the carbon dioxide level.
Duragesic Patch can be habit-forming and addictive, and is therefore not for use by those who have not used any kind of opiate painkiller before. Fentanyl slows down the nervous system.
The Duragesic patch should also not be used on children under 12 years of age or in children under the age of 18 who weigh less than 110 pounds.
Extended use of the Duragesic patch can lead to an addiction or dependence, both physiological and psychological, to fentanyl.
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.
See your doctor if you suffered an adverse side effect while using the Duragesic Patch.
Contact a Duragesic lawyer in your state
If you have been injured by the Duragesic Patch and have suffered any side effects, please contact our experienced Duragesic Patch lawyers now for a free evaluation.
