Patches sold by Actavis South Atlantic are being recalled because of a defect that could cause them to leak, putting patients or caregivers at risk of overdose.
The recalled patches have the company's name on the outer carton, and the company's old name, Abrika Pharmaceuticals, is printed on the pouches containing the patches. Damaged patches should not be handled.
This is the second recall involving fentanyl patches within a week. On February 12, PriCara recalled patches made by its affiliate, ALZA Corporation.
Fentanyl Patch Recall Announcements
About Fentanyl
Fentanyl is a Schedule II controlled substance, the highest level of control for drugs with a recognized medical use. The patch is applied to the skin and delivers fentanyl, a potent, strong opiate analgesic. The drug is slowly absorbed through the skin into the bloodstream and can relieve pain for up to three days from a single patch application.
The patch is only for people who experience moderate-to-severe chronic pain that is expected to last for weeks or longer and that cannot be managed by acetaminophen-opioid combinations, nonsteroidal analgesics, or as-needed dosing with short-acting opioids.
The powerful pain-relieving properties of all opiates are countered by significant risks of depressed breathing that can cause unexpected death. Signs of an overdose include trouble breathing or shallow breathing, extreme sleepiness or sedation, an inability to walk or talk normally, and feeling faint, dizzy, and confused. People who experience these symptoms should seek emergency medical attention. Removing the patch won't reverse the problem; the drug is still absorbed into the body for more than 17 hours after the patch is removed.
More about this drug from the FDA
del.icio.us
Digg this
