Duragesic Recall Expanded

February 20, 2008, 6:00AM. By Heidi Turner

Washington, DCDuragesic pain patches have been recalled for the second time in a week. The recall was announced after concerns that the patches leak fentanyl, causing potentially fatal side effects. Patients are now investigating the possibility of a lawsuit against the makers of Duragesic.

The expanded recall includes fentanyl patches from Actavis South Atlantic LLC. The company announced that 14 lots of the patches may be defective and are therefore being recalled. The lots affected by the recall include 25, 50, 75, and 100-microgram-per-hour patches and may also have the name Abrika Pharmaceuticals on the packaging. They all have an expiry date of May through August 2009.

This second recall was announced one week after PriCara, a division of Johnson & Johnson, and Novartis AG recalled their 25-microgram-per-hour fentanyl pain patches. Their recall was also announced because of concerns that the patch could leak medication. The concern was that some patches had a cut that would allow the fentanyl gel to leak out. The patches affected by the earlier recall had an expiry date of on or before December 2009. Approximately 32 million patches were affected by the recall.

Damaged patches should not be handled because contact with fentanyl can cause serious side effects. Such side effects include respiratory depression and fentanyl overdose. Skin that is exposed to the fentanyl should be rinsed with water. However, it should not be washed with soap or alcohol as any additional lubricants or chemicals could cause fentanyl to be absorbed more quickly.

Symptoms of a fentanyl overdose include difficulty breathing, clammy skin, extreme sleepiness, inability to think, talk or walk normally, dizziness, and confusion. Patients who use fentanyl patches and experience any of these symptoms should seek medical attention immediately.

Fentanyl patches have been recalled before. In 2004, a 75-microgram patch made by Janssen Parmaceutica Products was recalled because it also had a defect that resulted in possible overexposure to fentanyl. Furthermore, the FDA had issued multiple warnings about the danger of accidental overdose associated with the patches.

Duragesic patches are designed for use in patients with persistent, moderate to severe chronic pain. Furthermore, the patient must require around-the-clock opioid administration over an extended time and must have pain that is not managed by other means. The patient must also be considered opioid-tolerant.

Patients are now investigating lawsuits against Johnson & Johnson, alleging they were injured by the Duragesic patches. According to the Wall Street Journal, a past lawsuit involving alleged injury from Duragesic patches resulted in a $5.5 million verdict. Some wrongful death lawsuits have already been filed, alleging the patches caused numerous deaths.