FDA Blocks Wider Use of Fentora Due to Fentanyl Overdose Risk

Cephalon, Inc., the manufacturer of Fentora, has been informed by the FDA that they will not be allowed to expand the uses of their prescription painkiller due to the potentially fatal risk of fentanyl overdose the medication could pose.

Fentora is an oral medication that contains the powerful narcotic fentanyl . It belongs to the opioid group of prescription painkillers, which also includes codeine and morphine.

Fentora was approved by the FDA in 2006, for the limited purpose of treating breakthrough pain experienced by cancer patients who are already tolerant of opioid painkillers. Cephalon has been seeking wider approved uses for breakthrough pain among those with chronic lower back and nerve pain.

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The FDA has previously issued an alert to healthcare providers about potential Fentora side effects which could result in fentanyl overdose if it is prescribed off-label or abused, as the drug can be highly addictive.

In February 2008, Cephalon sent a letter doctors warning them to carefully follow Fentora dosing instructions and to prescribe the drug only to those who are already under a continuous opioid drug treatment.

The FDA has notified Cephalon that they will not approve the broader use of Fentora unless the drug maker can come up with a better way to inform users and the medical community about the fentanyl overdose risks.

An independent panel of experts convened by the FDA in May 2008, reviewed the potential for expanding the use of Fentora. The panel voted 17 to 3 against the wider use on the ground that greater availability of Fentora could increase the potential harm from abuse and overdose.

A number of deaths from fentanyl overdose have been associated with Fentora, as well as other powerful painkillers that contain fentanyl, such as the Actiq fentanyl lollipop and fentanyl pain patches.

Actiq Lollipop, which is another fentanyl drug manufactured by Cephalon, contains the painkiller in a lozenge on the end of a stick which the user sucks on. Actiq has been found to be widely prescribed off label for conditions like back pain and headaches, leading to a Congressional inquiry of Cephalon in March 2007.

6 Comments

  • LauraMarch 22, 2014 at 3:19 am

    Thank God someone (although its not the government) is talking about those of us in legitimate pain and Fentanyl is the only thing that stops the pain. Due to people with substance abuse problems I am supposed to suffer. Cancer is not the only pain and rarely the worst pain you can have. The reason Cancer becomes deadly in the first place is usually there are very few if any symptoms until your [Show More]Thank God someone (although its not the government) is talking about those of us in legitimate pain and Fentanyl is the only thing that stops the pain. Due to people with substance abuse problems I am supposed to suffer. Cancer is not the only pain and rarely the worst pain you can have. The reason Cancer becomes deadly in the first place is usually there are very few if any symptoms until your are either at a late stage in the game or your lucky enough to have a screening that detects it early enough.The friends and relatives I know who have had cancer either developed a lump and had a biopsy. Also a lot of the pain with the exception of Cancers like bone cancer and some others the pain comes from the treatment not the Cancer in itself. The chemotherapy and the radiation. I am so tired of being treated lie a drug seeking scum bag before anybody bothers to look at my records. I dont think all drug addicts are scumbags because if they are wealthy they get treatment & usually the royal treatment aka Charley Sheen, Robert Downey Jr. etc. I went off of all my pain medications including my Oxycontin for 7 months because of some crap heard nurse who I heard talking during one of my hospitalizations (I was there for my 7th back surgery)she was saying to the other nurses and a patient that I probably fractured my vertebrae on purpose to get drugs. I let this fat s___t head get me that upset. I said to her I hope your proud of what you said about someone you never met because I wasn't going to judge you but now that I see yo with high powered, judgmental finger pointed at me, why dont you get on an emergence number to gastric bypass or weight watcher because I'll bet you never met a junk food or candy bar you didn't like. I was in so much pain for seven months that I could not function and that is 7 months of my life and( I have a fatal lung disease) that I will never get back due to someones ignorance. Fentanyl is the ONLY medication that stops the pin almost 100%. I can live without the Oxycontin and have had it substituted every now and then but it doesn't help any where near the Fentanyl and I wish that wasn't the case because it is so inexpensive to make and I am being charge on an 80% markup when I researched it. We have to start being more vocal about those of us in legitimate pain are being punished. I am so sick of it. Don't blame me or the rest of us chronic pain sufferers (God knows that this is not a club anyone wants to be member of)when I have all the evidence you could possibly need with my MRI's & cat scans & surgeries. STOP blaming people in pain for the idiots who dont follow the law. Its making it harder and harder for those of us in pain to get the help we so desperately need. If I ever have to live with this pain after what I lived threw the 7 months I went off my medication I would rather be dead! There is no quality of life. Don't let these no compassion idiots who make these laws( please look up the REMS and TIRF laws to see what the FDA is doing) win. Year after year making it harder for us to get our medication. I will not go down without a FIGHT against these bastards..

  • BillMarch 1, 2012 at 4:14 am

    What is really a shame is the fact that virtually every single individual who has overdosed on Fentora was not taking them as prescribed. No doctor is going to prescribe Fentora at a level that will cause overdose. What happens is the patient takes it with alcohol, takes more than prescribed to get high, takes with other opiates, benzo's or barbituates which they get from other doctors, off the s[Show More]What is really a shame is the fact that virtually every single individual who has overdosed on Fentora was not taking them as prescribed. No doctor is going to prescribe Fentora at a level that will cause overdose. What happens is the patient takes it with alcohol, takes more than prescribed to get high, takes with other opiates, benzo's or barbituates which they get from other doctors, off the street or friends and then ODs. Then the FDA takes into account all of the street addicts who are overdosing from the powder fentanyl coming over from China and doesn't keep anything within context. So in order to TRY and keep these self destructive people from killing themselves (which they will do with something else if not Fentanyl) they deprive the legitimate, responsible, and productive people who suffer from intractable pain for whatever reason (My Excuse? Missing 1/2 arm, one foot and sustained grenade schrapnel injuries to my head, abdomin and legs/arms in Operation Rifle Sweep on 11/26/2003: US Army 3rd Armored Calvary. Pain from head injury, amputations wounds and internal damage from schrapnel entering abdomen and exiting back scraping spinal cord). I wear Fentanyl patches daily, hold a fulltime job and support a wife and four kids. I do this without being "High" because everyone who uses Fentanyl for real pain, doesn't get high. You get high if you use it without needing it. If I didn't have Fentanyl patches, I would be on Disability/Social Security being supported by the Taxpayers and wasting away. This is why I get furious when these dirtbags abuse these drugs. I have to suffer so they can get "High" because they can't deal with life. The courts should stick these people in rehab, jail, Army or let them kill themselves. But don't cause me to suffer and be incapable of supporting my family with honor because of these weak, selfish addicts.

  • j millsJuly 27, 2009 at 7:43 pm

    Please make fentora legal for chronic pancreatitis. It was the only thing keeping me functioning, now I live in constant sickly pain. Please find a solution. Please.

  • Matt L.July 2, 2009 at 8:48 am

    This is terribly unfortunate!! When prescribed and used correctly, Fentora is an absolutely incredible medication - with the potential to improve the quality of life for MILLIONS of Americans who suffer from LEGITIMATE pain (newsflash... cancer is NOT the only disease that causes pain!!). Yet (as a result of a few ignorant doctors who, incidently, should not be prescribing a medication without[Show More]This is terribly unfortunate!! When prescribed and used correctly, Fentora is an absolutely incredible medication - with the potential to improve the quality of life for MILLIONS of Americans who suffer from LEGITIMATE pain (newsflash... cancer is NOT the only disease that causes pain!!). Yet (as a result of a few ignorant doctors who, incidently, should not be prescribing a medication without first LEARNING about it), too many people -such as myself- are forced to live in constant, agonizing pain! MAKE THE DRUG AVAILABLE TO THOSE THAT NEED IT and HOLD THE DOCTORS RESPONSIBLE!! Why should SO MANY people have to suffer from the ignorance of so few?! Alcohol causes more deaths PER DAY than Fentora ever will... remember what happened when we took that off the market? The FDA and it's "expert panel" need to get their priorities straight!!!

  • DavidMay 25, 2009 at 5:10 am

    I was on Actiq, up to may 2007, 6 : 1200mcgs a day, and for over a year a 100 mcg fentynal Patch, and a 50 mcg patch now my teeth are eat up,

  • chawnSeptember 18, 2008 at 12:42 am

    do something about the medication. have had severe nerve damage for several years. this is the only medication that has helped except for having to go the dr and get a shot of demerol which knocks you out. i can work and function on the drug. the cost has got to come down or insurance companies will no longer cover me./thanks

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