Duragesic pain patches containing the prescription painkiller fentanyl were recalled Tuesday, because of a defect that could cause the patches to leak leading to a fatal overdose of the drug inside. Some of the patches may have a cut in the lining of the internal reservoir where the drug is stored in gel form. If the fentanyl gel leaks, it could cause a patient or caregiver to come into direct contact with this powerful drug. This could result in difficulty breathing and a potentially fatal overdose.
Fentanyl is mostly used to treat cancer pain, according to the FDA, and doctors say it’s a stronger painkiller than morphine. The drug is intended for chronic pain yet the FDA found cases where doctors prescribed it for headaches or post-surgical pain.
Deaths caused by defective patches have been the subject of multiple lawsuits in the last several years. The U.S. Food and Drug Administration issued a safety warning in December over the patches, saying improper use can cause breathing difficulties and death. That followed a July 2005 alert put out by the FDA after 120 patients taking the drug died. Johnson & Johnson said in November that it faced 72 lawsuits over the patches. Juries in Texas and Florida concluded that defective patches caused the deaths of Michaelynn Thompson and Adam Hendelson. A Texas state court jury awarded Thompson’s family more than $772,000 in damages, and a federal jury in Florida ordered the company to pay Hendelson’s family $5.5 million.
Different manufacturing problems caused Johnson & Johnson to recall versions of the patches in 1994 and 1996. A 2004 recall covered patches supplying 75 micrograms of the drug.
The current recall covers patches in the U.S. and Canada that release 25 micrograms of fentanyl in an hour, Johnson & Johnson said. The expiration dates are on or before December 2009. Duragesic patches generated $1.16 billion in global sales last year, making them Johnson & Johnson’s eighth-biggest selling product.
If this reservoir containing the gel form of the drug is cut, it can be seen when the foil pouch containing an individual patch is opened. Damaged patches should be flushed down the toilet and not handled. Skin that has been exposed to the gel should be thoroughly rinsed with water, but not washed with soap.