FDA Recalls Powerful Fentanyl Pain Medication Patches Because of Overdose Risk

By November 18, 2010Dangerous Drugs

As a dangerous prescription drug attorney, I know the pain medication Fentanyl (fentanil) is an ongoing safety problem for the FDA, with multiple recalls in various forms and under various names. That’s why I wasn’t surprised to see that the FDA has recalled about a million Fentanyl transdermal patches due to concerns about an overdose. Arthritis Today published an article about the recall Oct. 27, and the FDA updated its recall on Nov. 5 to include patients as well as health care providers. The recall is being blamed on a manufacturing error by Corium International, a Michigan company that makes drugs under contract for Fentanyl’s owner, Actavis Inc. The patches are believed to release the drug more quickly than intended, putting patients at risk for an overdose that could slow or stop their breathing, setting them up for brain damage and death. The FDA did not report any injuries or deaths related to the recalled patches.
Fentanyl is an opioid painkiller intended to manage severe pain when less powerful drugs do not help. The patches are supposed to release measured doses into the wearer’s bloodstream to manage pain over a long period. This is frequently used for cancer patients and patients undergoing surgery, as well as for people with certain kinds of arthritis. However, Fentanyl and Duragesic, another brand name for fentanil, have encountered repeated safety problems. Fentanil is derived from opium, making it highly addictive and very powerful. This has led to its use as a street drug and theft and misuse by hospital, clinic, nursing home and other medical employees.
That power is at the root of the safety recalls, most of which are recalls of the drug in patch form. Patches are intended to deliver the drug steadily into the patient’s bloodstream, but slight mistakes during manufacturing can make them deliver too much. Instead of merely killing the pain, an overdose can go further and depress the patient’s respiratory system. Victims can stop breathing or breathe only with difficulty, causing death. In fact, an overdose of fentanil from a legally prescribed Duragesic patch is blamed for the death of Jay Bennett, a former member of the band Wilco, in Illinois. Here in Missouri, inappropriate use of a Fentanyl patch intended for adults is blamed for the death of a six-year-old boy in Willow Springs.
As a pharmaceutical liability lawyer, I am pleased that Actavis is taking this issue seriously enough to recall the patches. But at the same time, I hope the FDA is looking seriously at whether a drug this powerful should be delivered by transdermal patch. This is not the first patch to come under fire; in fact, it’s not even the first fentanil patch to receive FDA action. Duragesic patches were blamed for deaths and other adverse events in 2005 and 2007. Two Fentanyl patch makers recalled products in 2008 because of an overdose risk from manufacturing defects. Another well-known patch safety problem had to do with Ortho Evra, a birth control patch blamed for causing blood clots by releasing too many hormones. Under these circumstances, it’s fair for drug industry observers to wonder whether patch delivery systems are right for drugs that require very careful monitoring of the dosage, which definitely includes Fentanyl.


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