Pain Patch Recall

Painkiller patches containing the highly potent drug fentanyl have been recalled because of a manufacturing defect that could result in fatal overdoses for some users (1).

The recalled pain patches, sold under the brand name Duragesic® by PriCara and generically by Sandoz, Inc., include certain 25 microgram-per-hour patches. Additionally, Actavis announced its patches sold under the Abrika and Actavis labels were being recalled because of a similar defect.If someone you care about died from overexposure to the drug fentanyl after using a pain patch, our drug injury attorneys would like to speak with you. Call us or fill out a free and confidential online case evaluation to find out how we can help you.
Update I:

The Food and Drug Administration (FDA) announced, “Actavis Inc., the United States manufacturing and marketing division of the international generic pharmaceutical company Actavis Group HF, today 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 expanded recall covers all of their CII pain patches and goes on to warn patients that they should not use these patches because of the potential to overdose on the highly potent drug inside the patches.

Update II:

According to The Associated Press, “Two Johnson & Johnson subsidiaries that make and distribute a painkilling skin patch must pay nearly $16.6 million to the family of a suburban woman who died from a drug overdose while using the product, a jury ruled Monday. The verdict is the fourth trial loss for the companies since 2006.

“A Sanford, FL., jury last month awarded $13.3 million to the family of Susan Hodgemire, 34, who died after undergoing back surgery and using the Duragesic patch. In June 2007, a federal jury awarded $5.5 million to the father of a 28-year-old man who died in 2003 while wearing the patch.”

The Associated Press originally reported that some of the recalled painkiller patches may have a hole inside of them where the potent narcotic fentanyl is stored. If fentanyl leaks out of the hole, it can cause either the patient or doctor/caregiver to come into direct contact with the drug, which can result in difficulty breathing and a fatal overdose (1).

The FDA Warns:

“Fentanyl is a very potent narcotic pain medicine. For patients who are not opioid-tolerant, the amount of fentanyl in one fentanyl patch of the lowest strength is large enough to cause dangerous side effects such as severe trouble breathing or very slow or shallow breathing. Use of fentanyl patches in such cases can even result in death (2).”

The painkiller patch is prescribed for patients who are in severe, chronic pain and have already developed a resistance to narcotic drugs (2). Cancer patients are sometimes prescribed the painkiller patch because of the extreme pain often associated with the disease. Fentanyl, the active ingredient in the painkiller patches, is roughly 80 times stronger than morphine.

In July 2008, The Associated Press reported that illegal versions of fentanyl manufactured in Mexico caused more than 1,000 deaths during the past several years.

Sources:

“Fentanyl Pain Patch Recalled: Voluntary Recall of Duragesic and Generic Fentanyl Patch Due to Overdose Risk,” by Miranda Hitti of WebMD
“Fentanyl Transdermal System (Patch) (marketed as Duragesic and generics) Overview,” from the Food and Drug Administration. Accessed 2/14/08 via www.fda.gov.

Duragesic® is a registered trademark of Johnson & Johnson and is used here only for the purpose of identifying the product in question.

This law firm is not affiliated with, sponsored by, or associated with The Associated Press, the Food and Drug Administration, Johnson & Johnson, or any of its subsidiaries.