PriCara Issues Recall for Duragesic Patches

Ortho-McNeil-Janssen Pharmaceuticals’ affiliate company PriCara issued a recall of its Duragesic painkiller patches on February 12, 2008. The patches included in the recall have an expiration date falling on or before December 2009 and are of the 25 microgram-per-hour (mcg/hr) variety.

Duragesic is the brand name for PriCara’s fentanyl-based painkiller patch. This transdermal painkiller is capable of providing users with 72 hours of controlled pain relief. Fentanyl is an extremely powerful opioid (synthetic narcotic) that is considerably stronger than morphine. Fentanyl patches are typically prescribed to cancer patients or others suffering from chronic pain, though FDA investigators have found a number of instances in which Duragesic has been prescribed as a treatment for severe headaches or postoperative pain relief.

The PriCara recall was issued as a result of increased FDA scrutiny surrounding the efficacy of the Duragesic patch. In December 2007, the FDA issued its second warning regarding the serious dangers associated with the misuse of fentanyl. Novartis’ Sandoz Inc. has also recalled its 25 mcg/hr fentanyl patches in response to the PriCara recall. Patients using fentanyl patches are advised to consult with their physician immediately to determine an appropriate course of action.

Duragesic Patch Defect

PriCara issued the Duragesic recall following reports of fentanyl gel leaking from an internal reservoir within the patch. If the lining of the patch is damaged and the gel exposed, patients could inadvertently come into direct contact with the extremely potent opioid, the results of which can be fatal.

PriCara has estimated that roughly two out of every million Duragesic patches are susceptible to the “leaking” defect. While this figure reflects an extremely low percentage of defective patches, the potentially fatal consequences associated with the defect warranted the recall.

Patients with a defective Duragesic patch are advised to flush it down the toilet immediately, taking care to avoid direct contact with the skin. Anyone who does come into contact with the fentanyl gel is advised to rinse the affected area with water immediately, avoiding soap. Breathing problems could be a sign of fentanyl intoxication, which requires immediate medical attention.

Duragesic Patch Lawsuits

If you or a loved one has been injured as a result of a Duragesic patch defect, you may be entitled to receive compensation for your pain and suffering. Drug manufacturers are responsible for ensuring the safety and efficacy of their products before marketing them to the public. Failure to do so is considered negligent and grounds for personal injury litigation.

The Pensacola personal injury attorneys of Aylstock, Witkin Kreis & Overholtz handle national litigation across the United States for victims injured by defective pharmaceuticals and medical devices. The lawyers and staff representing Aylstock, Witkin, Kreis & Overholtz are available to answer all your questions about the PriCara recall. Contact them today at (844) 794-7402.