What Is Fentanyl?
Fentanyl was developed by Janssen Pharmaceutical under the trade name of Sublimaze and now includes Duragesic Fentanyl patches and has been synthesized into lollipops and sprays. Fentanyl overdoses have been directly tied to the drug, including malfunctioning time-release fentanyl patches, simple overdose and cases of combination overdose.
Fentanyl Pain Patch Side Effects
Death and serious injury have resulted from the use of fentanyl skin patches for pain control. Fentanyl's side effects include diarrhea, nausea, constipation, dry mouth, somnolence, confusion, asthenia (weakness), abdominal pain, headache, fatigue, anorexia and weight loss, dizziness, nervousness, hallucinations, anxiety, depression, flu-like symptoms, sweating, dyspepsia (indigestion), dyspnea (shortness of breath), hypoventilation, apnea, and urinary retention, aphasia and altered mental states.
The use of fentanyl with all cytochrome P450 3A4 inhibitors (such as ritonavir, ketoconazole, itraconazole, troleandomycin, clarithromycin, nelfinavir, nefazodone, amiodarone, amprenavir, aprepitant, diltiazem, erythromycin, fluconazole, fosamprenavir, grapefruit juice, and verapamil) may result in an increase in fentanyl plasma concentrations, which could increase or prolong adverse drug effects and has been found to cause potentially fatal respiratory depression.
Fentanyl Transdermal system is CONTRAINDICATED in the treatment of postoperative and acute pain and in patients who are not opioid-tolerant. Death and other serious medical problems have occurred when people were accidentally exposed to Fentanyl Transdermal system. Examples of accidental exposure include transfer of a Fentanyl Transdermal system from an adult's body to a child while hugging, accidental sitting on a patch and possible accidental exposure of a caregiver's skin to the medication in the patch while the caregiver was applying or removing the patch.
Placing Fentanyl Transdermal system in the mouth, chewing it, swallowing it, or using it in ways other than indicated may cause choking or overdose that could result in death.
FOR USE IN OPIOID-TOLERANT PATIENTS ONLY
Fentanyl Transdermal system 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.
Fentanyl can be abused and is subject to criminal diversion. The high content of fentanyl in the patches (Fentanyl Transdermal system) may be a particular target for abuse and diversion.
Fentanyl Transdermal system 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 nonsteroidal analgesics, opioid combination products, or immediate-release opioids
Fentanyl Transdermal system 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 Fentanyl Transdermal system 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, 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 postoperative pain, including use after outpatient 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)]
FDA's Role in Fentanyl Pain Patch
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Representation from an attorney may be the only way those negatively affected by the drug may be able to be compensated for damages. The attorneys at Vititoe Law Group have many years of experience dealing with the largest pharmaceutical companies.
For more information, call Vititoe Law Group at 818-851-1886.
If your loved one has suffered death, or you have suffered from taking Fentanyl Pain Patch, you may deserve monetary compensation for your injuries, and it is your duty as a consumer to hold the negligent company responsible.
If you feel you might have suffered damage as a consequence of taking Fentanyl Pain Patch, give us a call today for a free consultation.
Attorney Referrals: If you are an attorney concerned about the damage Fentanyl Pain Patch have done to a client, contact us today.