Defective Medical Device
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).
Update: The 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 voluntarily 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 a potential to overdose on the highly potent drug inside the patches.
The FDA later issued the following statement:
"There have been reports of serious adverse events including allergic or hypersensitivity-type reactions, with symptoms of oral swelling, nausea, vomiting, sweating, shortness of breath, and cases of severe hypotension. Most events developed within minutes of heparin initiation although the possibility for a delayed response has not been excluded [...] Serious adverse events have recently been reported in patients who received these higher bolus doses."
The manufacture of multiple-dose vials of heparin sodium has been suspended pending the completion of an extensive ongoing investigation to determine the root cause of the problem. Because heparin sodium is a medically necessary product and serious public health consequences would result if there were a sudden shortage of the drug, the multiple-dose vials of heparin sodium manufactured by Baxter that are currently in distribution will not be recalled. See the FDA Public Health Advisory for Agency recommendations to healthcare professionals on the use of heparin sodium for injection.
1) “Fentanyl
Painkiller Patches Recalled,” by Natasha T. Metzler of The Associated Press.Accessed 2/14/08 via www.ap.org.
2) “Fentanyl
Transdermal System (Patch) (marketed as Duragesic and generics) Overview,” from the Food and Drug
Administration. Accessed 2/14/08 via www.fda.gov.
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