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).

The recalled pain patches, sold under the brand name Duragesic® by PriCara and generically by Sandoz, Inc., include all 25 microgram-per-hour patches expiring on or before December 2009 (1).  Additionally, Actavis, Inc. announced its patches sold under the Abrika and Actavis labels were being recalled because of a similar defect.

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 Associated Press reports that some of the recalled painkiller patches may have a hole inside of them where the potent narcotic fentanyl is stored. If fentanyl leaks out of the hole, it can cause either the patient or doctor/caregiver to come into direct contact with the drug, which can result in difficulty breathing and a fatal overdose (1).

The Food and Drug Administration (FDA) warns:

“Fentanyl is a very potent narcotic pain medicine. For patients who are not opioid-tolerant, the amount of fentanyl in one fentanyl patch of the lowest strength is large enough to cause dangerous side effects such as severe trouble breathing or very slow or shallow breathing. Use of fentanyl patches in such cases can even result in death (2).

The painkiller patch is prescribed for patients who are in severe chronic pain and who have already developed a resistance to narcotic drugs (2). Cancer patients are sometimes prescribed the painkiller patch because of the extreme pain often associated with the disease. Fentanyl, the active ingredient in the painkiller patches, is roughly 80 times stronger than morphine.

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.

If you or someone you care about has suffered after using a pain patch because of overexposure to the drug fentanyl, you may need to speak with our lawyers. Call us or fill out a free and confidential case evaluation to find out how we can help you.

Sources:

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.

Duragesic® is a registered trademark of Johnson & Johnson and is used here only for the purpose of identifying the product in question.

This law firm is not affiliated with, sponsored by, or associated with The Associated Press, the Food and Drug Administration, or Johnson & Johnson or any of its subsidiaries.

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