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Fentora® Side Effects Lawsuit

Fentora (fentanyl buccal tablet), has been linked to serious adverse side effects and patient deaths.

If you or a loved one have suffered from a Fentora induced side effect including an overdose related injury or death, you should contact us immediately. You may be entitled to compensation for your injuries and we can help.

UPDATE: The U.S. Food & Drug Administration has received reports of serious side effects including death in patients who have taken Fentora. The adverse event reports have included, (i) prescribing to non-opioid-tolerant patients, (ii) misunderstanding of dosing instructions, or (iii) inappropriate substitution of Fentora for Actiq by pharmacists and prescribers. The directions for using Fentora must be followed exactly to prevent death or other severe side effects from overdosing with fentanyl. The FDA has asked Cephalon, the manufacturer of Fentora, to update the Fentora label and Medication Guide for patients with additional information on the safe use of Fentora.

What’s the problem?

On September 13, 2007, Cephalon issued two Dear Healthcare Professional Letters to inform prescribers and other healthcare providers of important safety information regarding Fentora.

On September 27, 2007, the FDA issued a Public Health Advisory regarding the “Safe Use of Fentora” as well as an updated Podcast.

Fentora is indicated only for the management of breakthrough pain in patients with cancer who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain. Serious adverse events, including deaths, have occurred in patients treated with Fentora.

These deaths occurred as a result of:

  • improper patient selection (e.g., use in opioid non-tolerant patients),
  • improper dosing, and/or
  • improper product substitution.

The healthcare professional letters provide key points regarding appropriate patient selection and proper dosing and administration of Fentora to reduce the risk of respiratory depression.

FDA Video: Warning on Fentora Buccal Tablets

Below is an excellent video published by the U.S. Food & Drug Administration (FDA), which warns patients and physicians of serious side effects including death among patients who have taken Fentora.

Read the Full Transcript: Warning on Fentora Buccal Tablets

Do I Have a Fentora Lawsuit?

The Defective Drug & Products Liability Litigation Groups at our law firm are an experienced team of trial lawyers that focus exclusively on the representation of plaintiffs in drug side effect lawsuits.  We are currently accepting new Fentora side effect cases in all 50 states.

If you or a loved one have suffered from a Fentora induced side effect including an overdose related injury or death, you should contact us immediately. You may be entitled to compensation for your injuries and we can help.

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