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DURAGESIC
Duragesic is an adhesive "pain patch" that is applied to the skin. It delivers a steady dose of fentanyl (a powerful opiate pain medication), over an extended period of time, to persons suffering from chronic and/or debilitating pain.
On Apr-05-04, Janssen Pharmaceutical Products LP issued an urgent recall for defective patches. The recall applies only to specific manufacturing lots of the 75mcg strength patches, which have a faulty seal that permits full strength fentanyl to leak from the patch. This could result in patients being given an overdose of fentanyl, which can cause fatal respiratory and/or cardiac arrest.
Recalled Duragesic lot numbers:
NDC no. 50458-035-05
Lot Control nos. 0327192, 0327193, 0327294, 0327295, and 0330362
Due to the dangerous nature of the drug, Duragesic contains a black-box warning label explaining the risk of accidental fatal overdose and respiratory depression or hypoventilation.
Symptoms and Side Effects of Duragesic
Medical professionals are concerned that patients using the Duragesic pain patch are susceptible to accidental overdose which can be fatal. Overdose can occur when the patch is damaged, cut, or defective (as those involved in the recent recall).
Symptoms of a fentanyl overdose include slow breathing, seizures, dizziness, weakness, loss of consciousness or coma, confusion, tiredness, cold and clammy skin, and small pupils. Continued exposure to uncontrolled amounts of fentanyl can lead to addiction and dependency. The opioid drug stays in the system for up to 72 hours.
Janssen also warns of other withdrawal side effects and potential damage to the cardiovascular system (bradycardia) and the central nervous system. Long term side effects of Fentanyl are not known.
DURAGESIC NEWS
Child dies after foster mother applies Duragesic pain patch to her neck. (May-19-08) FOX NEWS: DURAGESIC DEATH
Two men charged in death of woman who swallowed a Duragesic patch. (May-06-08) RICH: DURAGESIC DEATH
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