Fentanyl Pain Patch RecallFentanyl pain patches contain fentanyl, a very potent Schedule II opioid medication. Schedule II opioid substances include fentanyl, morphine, methadone and others. Fentanyl is many times stronger that morphine. If the patches leak the fentanyl gel, very serious adverse effects may occur, including respiratory depression and death.
Fentanyl pain patches went on the market in 1990 under the Duragesic® brand name, but a generic version was sold in 2005.
Juries have awarded millions of dollars in damages to persons wearing the Duragesic® brand of fentanyl pain patch, sold by New Jersey- based Janssen Pharmaceutica, Inc. and another company, Alza Corp., both of which are subsidiaries of the New Jersey-based Johnson & Johnson.
The FDA has stated that 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. The pain patch was prescribed for cancer patients but then its use for other patients became more widespread. Hundreds of deaths have been associated with fentanyl pain patches, which may have caused those fatalities by leaking.
Signs of 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.
Two fentanyl patch recalls were issued in early 2008, due to a risk that users could experience respiratory depression or fentanyl overdose. Different manufacturing defects at different plants have resulted in recalls involving the brand name Duragesic® pain patch and generic fentanyl patches sold by Sandoz and Actavis. The fentanyl gel in these patches could leak out and come into direct contact with the skin, resulting in serious and potentially fatal injuries. On February 13. 2008, Johnson & Johnson issued a fentanyl patch recall for 95 lots of their patches after a manufacturing defect was discovered. Some were found to contain a slice along one side of the drug reservoir, which could case the fentanyl gel to leak. On
February 18, 2008, a second fentanyl patch recall was issued for 14 lots of generic patches sold by Actavis, Inc. These patches, which were manufactured for Actavis by Corium International, might have a "fold-over" defect, which may allow the fentanyl gel to leak directly onto the skin. The recalled Actavis fentanyl patches might also contain the name Abrika Pharmaceuticals.
On March 1, 2008, Actavis Inc., announced that its subsidiary, Actavis South Atlantic LLC, is proceeding with the voluntary recall from wholesalers and pharmacies of all lots of Fentanyl transdermal system CII patches sold in the United States. This recall was an expansion of the Company's initial recall of 14 lots of Fentanyl transdermal patches announced on
February 17, 2008.
Two lots of Duragesic® pain patches were recalled on December 31, 2008 by the Pri-Cara division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., which is a unit of Johnson & Johnson. The reason given was that cuts in the product might allow direct exposure to the fentanyl gel.
Millions of pain patches have now been recalled. Manufacturers include Alza, Sandoz, Janssen, Mylan, Watson and Actavis.
On April 18, 2012, the FDA reminded the public that it had evaluated 26 cases of children being exposed to Fentanyl Pain Patches over 15 years, with 10 resulting in death and 12 resulting in hospitalization. Sixteen occurred in children under two years of age. The FDA in 2005 and 2006 had previously warned about overdose risks with these pain patches and in 2011 warned again about proper disposal of them.
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