Fentanyl Patches Recalled
February 15, 2008
On February 12, 2008, PriCara announced that patches containing the prescription painkiller "fentanyl" are being recalled. According to the PriCara Web site, the 25 microgram-per-hour fentanyl patches are being recalled due to potentially fatal flaws that could result in a lethal overdose to patients. Fentanyl is a potent Schedule II opioid medication, and exposure to fentanyl gel can lead to very serious adverse events, including respiratory depression and death.
According to the PriCara Web site, the 25 mcg patches recalled may have a cut along one side of the drug reservoir within the patch, potentially exposing patients to a potentially fatal overdose of fentanyl. The patches have been sold in the United Stated under the brand name "Duragesic" by PriCara. Generic versions were sold by Sandoz, Incorporated. All of the recalled patches have expiration dates on or before December of 2009, and were manufactured by a PriCara affiliate, the ALZA Corporation, which is a division of Ortho-McNeil-Janssen Pharmaceuticals, Incorporated. PriCara, the ALZA Corporation and Ortho-McNeil-Janssen are all subsidiaries of the Johnson & Johnson Company.
Previously, in July of 2005, the FDA issued an advisory emphasizing the limited safe uses of the fentanyl patch. Despite the advisory, the FDA apparently continued to receive reports of death and life-threatening events in patients who suffered overdoses while using the fentanyl patches, and the FDA issued an updated advisory on December 21, 2007. In the Advisory, the FDA stated that the fentanyl patch "is only indicated for use in patients with persistent, moderate to severe chronic pain who have been taking a regular, daily, around-the-clock narcotic pain medicine for longer than a week and are considered to be opioid-tolerant."
If you wish to speak to us about a potential claim or an injury caused by Fantanyl Patches. The attorneys
at Paris & Chaikin, PLLC, are available to answer your questions.
Consultations are free with no obligations. CALL OUR FIRM TODAY
AT 212-742-0476.
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