Approximately one million fentanyl patches for chronic pain recalled from store and pharmacy shelves in 2008. The U.S. Food and Drug Administration and drug maker Actavis Inc. worked to get the word out, but they were targeting retailers and wholesalers, not consumers.
Actavis voluntarily took this step after lab tests showed the active ingredient in one batch of patches produced in Grand Rapids, Mich., by Corium International was releasing medication into the bloodstream too quickly. As a precaution, the company is recalling 17 other lots, too.
Actavis’ Fentanyl Transdermal System patches are individually wrapped and come five to a box. One lot equals 12,000 boxes.
“Actavis is conducting a voluntary recall to the wholesale and retail level only of 18 lots of 25 mcg/hour Fentanyl Transdermal System. Patients who use this product are not being asked to take any action,” says a company representative.
Fentanyl patches are a popular type of treatment for people suffering from moderate to severe chronic pain – such as people with cancer or some forms of arthritis. They release a steady and controlled stream of the opiod fentanyl through the skin. An accelerated release of the medication could cause a variety of problems for patients including breathing and respiratory issues and increased sedation, but the company says it’s unaware of any injuries associated with this issue.
The patches included in the recall have expiration dates ranging from December 2011 to April 2012. The company says while wholesalers and retailers need to return all of the recalled product they have in stock, consumers should continue to use their fentanyl patches as instructed.
The American Pain Foundation doesn’t like that message. The group has sent out its own alert to more than 100,000 people out of concern that the recall was not directed at patients. The group is urging Actavis to extend the recall to consumers.
“What’s odd about this one is there was a recall from the pharmacists’ shelf but not from the medicine cabinet. You tell me the logic of that,” says Will Rowe, chief executive officer of the American Pain Foundation. “If it’s bad enough to take off the pharmacists' shelf, why isn’t it bad enough to take out of the medicine cabinet?
“Our message [is]: Take it out of your medicine cabinet and don’t use it,” Rowe continues. “Alert your physician you have one of these lot numbers so you can replenish the medicine and contact the company saying you want a refund or you want it replaced – which I think the company should have done in the first place.”