California Fentanyl® Lawyers

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 lolipops and sprays. Fentanyl overdoses have been directly tied to the drug, including malfunctioning time-release fentanyl patches, simple overdose and cases of combination overdose.

What are the dangers of Fentanyl®?

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 post-operative 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.

Box Warning
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 non-steroidal 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 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)]

Fentanyl® References

Regnard C, Pelham A. Severe respiratory depression and sedation with transdermal fentanyl: four case studies. Palliative Medicine, 2003; 17: 714-716.
Heroin Task Force Links Drug Dealer to Fatal Overdose
Nurs BC. 2005 Feb;37(1):30.Used fentanyl patch could lead to an inadvertent overdose.

Deaths Seen With Fentanyl Narcotic Pain Patch

July 15, 2005 -- The FDA today has issued a health advisory regarding the safe use of fentanyl skin patches (brand name Duragesic) in response to reports of deaths in patients using this potent narcotic medication for pain management.

Deaths and overdoses have occurred in patients using both the brand name product Duragesic and the generic product fentanyl. The directions for using the Fentanyl® skin patch must be followed exactly to prevent death or other serious side effects from overdose.

e FDA Fentanyl® Recall

If you have experienced while taking Fentanyl® ; or were otherwise injured by taking Fentanyl®;, you are entitled to compensation. If you or a family member have taken Fentanyl®; and developed problems, you should seek a free consultation regarding your legal rights. Our Fentanyl® lawyers have the experience and resources necessary to obtain compensation from pharmaceutical companies.

Consider Filing With Us

Lawsuits have been filed over Fentanyl®. There are indications that pharmaceutical company has downplayed the known risks of Fentanyl® usage, including respiratory failure. If you or your loved ones have experienced injury, complications or death, you can act now. We can help you get the compensation you deserve.

Use the Free Evaluation form to tell us about your situation or call us today.

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