FDA concerned about Fentora problems with wider use

Harvey Kirk

By Harvey Kirk
Posted May 5, 2008

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Cephalon, Inc. is attempting to seek FDA approval for Fentora tablets to be used for sudden pain in non-cancer patients who have already developed a tolerance to opioids. An FDA advisory panel is scheduled to meet on Tuesday to review the subject. Documents released in advance of the meeting indicate that the FDA is concerned that wider approval could have a “devastating effect” due to the risk of Fentora overdose and abuse.

Fentora is a prescription pain medication which contains fentanyl, a very strong and highly addictive narcotic . There have been many reports of Fentora problems caused by the drug being prescribed at the wrong doses or used incorrectly. In addition, the FDA issued an alert in September 2007 regarding the risk of fentanyl overdose deaths linked to off-label use of Fentora.

Cephalon originally designed Fentora as a substitute for their Actiq lollipops, which contain fentanyl in a lozenge on the end of a stick. Both Fentora and Actiq are currently approved for treatment of unmanagable breakthrough pain in cancer patients and they are only to be given to individuals who are already tolerant of opioid drugs. However, both medications are already widely prescribed “off-label” to individuals who do not have cancer.

Once a medication is approved by the FDA for any purpose, doctors are able to prescribe the drug “off-label” for non-approved use. Although drug makers are not supposed promote their medications for unapproved uses, Cephalon has been accused of sending sales representatives to discuss the benefits of Actiq with general practitioners, sports injury doctors and other physicians who were not likely to treat cancer-related pain.

>>PRIOR POST (3/26/2007): Makers of Actiq Lollipop part of Congressional Inquiry

The panel of outside experts convened by the FDA will review whether wider use of Fentora is appropriate. According to Bob Rappaport,from the FDA’s Division of Anesthesia, Analgesia and Rheumatology Products, expanded use of Fentora “may increase the availability of the product for diversion, abuse and misuse.” It may also increase the occurrences of accidental fentanyl toxicity overdose due to the potency of the drug. Although the FDA is not required to follow the recommendations of their advisory panels, they usually do.

OFF-LABEL FENTORA OVERDOSE LAWSUITS

The fentanyl lawyers at Saiontz & Kirk, P.A. are reviewing potential Fentora overdose lawsuits throughout the United States on behalf of individuals who died after receiving the powerful pain killer to treat non-cancer related pain. Lawsuits are also being investigated for overdoses and deaths associated with other fentanyl products such as the Actiq lollipop and Duragesic fentanyl patch. If a friend or family member has died as a result of fentanyl toxicity after taking Fentora, Actiq or using the Fentanyl Patch, request a free consultation and claim evaluation.

3 Comments • Add Your Comments

  • thematrix777 says:

    I have Reflex Sympathetic Dystrophy (RSD) and if you look it up on the McGill Pain chart it shows higher than cancer pain levels. So you can see what I deal with daily.

    RSD is a neurological, chronic, progressive condition and has no cure.

    I have used Fenanyl patches for 5 yrs now. I never had problems except 1 time I was given a “gel” type patch. They are very bad. I had my doctor switch them immediately. You have to make sure the pharmacy knows NOT to give you gel patches. I also changed pharmacies.

    Anyway, I have also used Actiq lollipop and Fedora. They were both fine. Just too expensive so I stopped using them. Some common sense by patients have to be used! Patients are in control of these things. If you follow directions correctly you will not have problems. Patients Beware!

    I am homebound, in a wheelchair, no use of hands, arms or legs. Dependent on daily care, 24/7. I do depend on “non-cancer” drugs because my pain is so great. Would you really deprive someone like me the comfort I require?

    Posted on January 17, 2009 at 3:46 pm

  • Ed H says:

    I too am a RSD sufferer, and have also been prescribed the fentanyl patch since 6/03. I was using Fentora, but my insurance company determined that after 10 months of Fentora use, that they would no longer cover it’s use for non cancer pain sufferers…. go figure…. It worked so well, and I would jump at the chance to get it back. However, at the cost of $2800 a month, I cannot afford it, without my health insurance covering it’s cost.

    Posted on April 14, 2009 at 4:11 pm

  • Sam says:

    The FDA needs to please pass Cephalon’s request for the fentora so people other than cancer patients can use this medication. I have a severe case of MS with cervical spine lesions that cause me total body pain all day and yes that means I have breakthrough pain all day everyday despite the oxycontin and morphine I take every 4 hours. I have to live in bed because United Healthcare, Caremark, or the company I am on LTD with Bristol Myers Squibb cut me down from 12 fentora a day to 4 fentora a day almost killing me because they are playing doctor or God so it seems, and now have taken it away completely, when I was already taking it for years. The 4 pills a day is useless because I need two 800mcg fentora at a time to help me through the worst times throughout my short day because I have to try to sleep as much as possible to avoid my pain since I don’t have enough fentora and can’t afford it myself. I am living on disability so I am broke and will be going deeper and deeper into debt every month because for me to just lay in bed and stay alive I need at the least 6 boxes of fentora 28 pills in each box so for 30 days this gives me almost 6 pills a day when to have a life outside of laying in bed I would need to have 12 boxes a month or more which was what I was getting before everything started being taken away from me obviously for monetary reasons but of course they say because I don’t have cancer.Another fact people may want to know is that 80% of the people taking fentora for their breakthrough pain do not have cancer. This is so obvious that the FDA needs to let it be used for anyone with severe breakthrough pain. I am sure this has happened to many people and I truly know how you feel and I am sorry for that. How can I be expected to want to live now without any pain management at all and since this all started in 2001 I have tried every pain medication, anti-seizure meds, anti depressants, etc…and every other class of drugs that they claim may help with pain, also acupuncture made me have an exacerbation so my MS didn’t like that at all, so all there is that helps me is fentora and now I believe Caremark and BMS have killed me because when my savings runs out soon I will have to get into so much debt it’s not worth fighting this disease anymore, especially since I am now getting no help from anyone to fill the prescription for the only breakthrough pain medicattion that has ever helped me.

    Posted on August 8, 2009 at 10:48 pm

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