|
DURAGESIC® Patch contains a high concentration of a potent Schedule II opioid agonist, fentanyl and has been linked to serious injury and death.
DURAGESIC® contains a high concentration of a potent Schedule II opioid agonist, fentanyl. Schedule II opioid substances which include fentanyl, hydromorphone, methadone, morphine, oxycodone, and oxymorphone have the highest potential for abuse and associated risk of fatal overdose due to respiratory depression.
DURAGESIC® is indicated for management of persistent, moderate to severe chronic pain that: • requires continuous, around-the-clock opioid administration for an extended period of time, and • cannot be managed by other means such as non-steroidal analgesics, opioid combination products, or immediate-release opioids DURAGESIC® should ONLY be used in patients who are already receiving opioid therapy, who have demonstrated opioid tolerance, and who require a total daily dose at least equivalent to DURAGESIC® 25 mcg/h. Patients who are considered opioid-tolerant are those who have been taking, for a week or longer, at least 60 mg of morphine daily, or at least 30 mg of oral oxycodone daily, or at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid.
Because serious or life-threatening hypoventilation could occur, DURAGESIC® (fentanyl transdermal system) is contraindicated: • in patients who are not opioid-tolerant • in the management of acute pain or in patients who require opioid analgesia for a short period of time • in the management of post-operative pain, including use after out-patient or day surgeries (e.g., tonsillectomies) • in the management of mild pain • in the management of intermittent pain [e.g., use on an as needed basis (prn)] (See CONTRAINDICATIONS for further information.)
FDA is looking into reports of death and other serious side effects from overdoses of the narcotic fentanyl in patients using the fentanyl transdermal skin patches for pain control. Directions for using the fentanyl skin patch must be followed exactly to prevent death or other severe side effects that can happen from using too much (overdosing) fentanyl. These directions are provided in the patient package insert.
If you or someone you love has been injured as a result of the the Fentanyl transdermal or Duragesic skin patches you may be entitled to monetary compensation. For a free case evaluation, please fill out the form below:
|