Fentora® Linked to Life-Threatening Side Effects & Deaths
Fentora® Resources
S&C Related Contents
>> Fentora®
FDA Fentora® Warnings
FDA Warns of Potential Serious Side Effects with Breakthrough Cancer Pain Drug (9/27)
FDA Public Health Advisory - Important Information for the Safe Use of Fentora® (fentanyl buccal tablets) (9/27)
FDA Fentora® Podcast
Podcast: Safe Use of Fentora® (fentanyl buccal tablets)
Cephalon Warning Letters
Dear Doctor Letter (9/13)
Dear Healthcare Professional Letter (9/13)
Other Fentora® Resources
Fentora® Label & Medication Guide
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 adverse event, overdose or an unfortunate 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.
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.
Attention Attorneys: We do not publish prior verdict/settlements. If you are an attorney and would like to refer us a case or for us to send you a profile of prior award judgments or average referral fees, please visit the attorney referral section of our website.
Free Confidential Case Evaluation
Toll Free 24 hrs/day (866) 588-0600
Secure 128-bit SSL Encrypted Email Communication - Click Here.
Secure 1024-bit SSL Encrypted Live Chat Communication - Click Here.
= Required Field
Fentora® Side Effects & Lawsuit News (National)
| Breakthrough Pain Fast-acting players will capture majority market ... - BioPortfolio Table 1: Prevalence of breakthrough pain across the seven major markets, 2006 16 Table 2: Estimation of the breakthrough pain market across the seven major markets, 2005 19 Table 3: Characteristics of immediate-release opioids useful for breakthrough ... BioDelivery Sciences: set to break into opioid market - Pharmaceutical Business Review BioDelivery Sciences and its commercial partner Meda Pharmaceuticals have announced positive pivotal Phase III data with BioErodible MucoAdhesive (BEMA) Fentanyl at the American Pain Society meeting in Tampa, Florida. The formulation is being trialed ... Clearwire up on Sprint Nextel deal - CNBC NEW YORK - Clearwire shares rose sharply in premarket trading Wednesday on a deal forming a new wireless venture with Sprint Nextel Corp. The new company, to be named Clearwire, will receive $3.2 billion in capital from a group of investors including ... On the Watch: Cisco and Disney report quarterly results - CNBC NEW YORK - Shares of Cisco Systems Inc. may see heavy trading Wednesday after the networking equipment maker posted a larger-than-expected profit in its fiscal third quarter. Cisco's profit fell 5 percent for the quarter, but its adjusted profit ... Exclusive Reports - Philadelphia Business Journal Cheesecake maker fears a sour fate Small banks bouncing back Tourism measuring primary effects Presby heart program takes flight A tale of one block: The Red Coats are coming up for sale Vanguard Group inks lease, readies for groundbreaking Quaker ... Cephalon giving $4M to Franklin Institute - Philadelphia Business Journal FDA: Expanded Fentora label could increase abuse [Philadelphia] Former Pa. AG named general counsel at Cephalon [Philadelphia] Cephalon cancer pain drug approved in European Union [Philadelphia] The call is out for tourists from up north ... Thoratec gets FDA approval for new heart pump - East Bay Business Times Emergent BioSolutions buys anthrax vaccine candidate [Baltimore] Behind the curtain of e-learning, where curriculum and technology meet [Tampa Bay] FDA: Expanded Fentora label could increase abuse [Philadelphia] Thoratec Q1 revenue up 12 percent ... NY wants drug companies to help dispose of old medication - Sun and Press ALBANY -- Americans take a lot of prescriptions and over-the-counter drugs, and so it follows that there are a lot of leftovers they have to dispose of. Should they flush them down the toilet, pack them in with coffee grinds, seal them in a bag and ... Cephalon gets EU approval for pain drug - Philadelphia Inquirer Cephalon Inc., of Frazer, said today that its oral medication to treat breakthrough cancer pain has received European regulatory approval. The medicine is an oral formulation of the pain therapy fentanyl for adult patients who already take an opioid ... Cephalon Announces European Commission Approval of EFFENTORA for the ... - PR Newswire FRAZER, Pa. and MAISONS-ALFORT, France, April 14 /PRNewswire-FirstCall/ -- Cephalon, Inc. (Nasdaq: CEPH ) announced today that the European Commission has granted marketing authorization for EFFENTORA(TM), a buccal tablet formulation of fentanyl ... |
