Johnson & Johnson and Novartis recently announced a recall of Duragesic transdermal pain patches after discovering that certain manufacturing defects could cause a fentanyl overdose when the patches leak and release potentially fatal doses of fentanyl, the main painkiller in the Duragesic patches.

This is not the first time a J&J patch has been at the center of litigation (such as, Ortho Evra). It is also not the first Duragesic recall; Duragesic patches have received many safety warnings and have also been voluntarily recalled a number of times, including a March 2004 Duragesic recall of some batches of the 75 microgram patch. The U.S. Food and Drug Administration (FDA) issued a safety warning in December 2007 over the patches, saying improper use could cause breathing difficulties and death. That followed a July 2005 FDA alert put out after 120 patients taking the drug died. Johnson & Johnson stated in November 2007 that it faced 72 lawsuits over the patches.

Most recently, in February 2008, Johnson & Johnson voluntarily recalled all 25-microgram-per-hour patches that are sold in the U.S. by the company's PriCara unit and Sandoz. Johnson & Johnson stated they instituted the recall because manufacturing defects in the 25 microgram patches may cause leaks that can lead to fatal overdoses. It estimated that in all, about 32 million patches will be recalled.

An overdose of fentanyl can result in some of the following symptoms:

-labored and slow breathing
-seizures
-dizziness
-weakness
-unconsciousness or coma
-fatigue
-cold, clammy skin
-confusion
-tiny pupils

In addition, continued exposure to unregulated quantities of the drug, which is an opioid, can lead to dependency problems and addiction. Fentanyl can remain in a Duragesic patch user's system for up to 72
hours.

Other Side Effects of Duragesic

The long-term side effects of Duragesic patches (specifically of fentanyl) have yet to be determined, but because of fentanyl's classification as an opioid, users can experience side effects of withdrawal symptoms and potential damage to the cardiovascular and central nervous systems.

In case of an accidental overdose, call a poison control center and local emergency services immediately.

Because the safety of Duragesic patch users is in question, it's important to investigate the details of this recall very carefully. If you have suffered from a Duragesic overdose, you may be eligible for damages or remedies that could be awarded from a Duragesic Class Action or Duragesic Pain Patch Lawsuit. Check with an attorney to see if you qualify.