Actiq lollipop is a part of Congressional inquiry

Harvey Kirk

By Harvey Kirk
Posted March 26, 2007

ADD YOUR COMMENTS 5

The makers of the Actiq lollipop pain medication are one of five pharmaceutical companies who received a letter from U.S. Congress Rep. Henry A. Waxman earlier this month, as part of his investigation into inappropriate marketing and incomplete research regarding drugs and medical devices.  In recent months, the powerful fentanyl lollipops have also been the subject of several lawsuits filed by users who suffered an overdose, serious addiction or death after being give the drug “off-label”. 

>>INFORMATION: Actiq lawsuits

Rep. Waxman, a California democrat, is chairman of the House Oversight and Government Reform Committee, which is investigating allegations of improper actions by several pharmaceutical companies.  Concern has been expressed that complete research results may not have been turned over to the FDA and that drugs were marketed and promoted for uses that were not established as safe.  At public hearings, Waxman has accused drug makers of “profiteering”, sometimes at the expense of consumer safety.

ACTIQ LOLLIPOP PROBLEMS

The Actiq lolipop is a pain medication which contains fentanyl, a powerful and highly addictive substances.  The fentanyl is contained in a berry flavored “candy” placed on the end of a stick, like a lollipop.  As a result of its ease of use and aggressive marketing by the drug’s maker, it has been widely overused and abused, resulting in injuries for individuals who never should have been given the drug.

A spokeswoman for Cephalon, Inc., the manufacturer of the Actiq lollipop, indicated the company was surprised to be a part of the inquiry.  However, the company has been the subject of scrutiny in the press and through Actiq lawsuits as a result of their questionable methods of selling the drug which have led to the pain medication being prescribed for uses which were not approved or determined to be safe in clinical trials.

The FDA only approved Actiq for use in cancer patients who were unable to control their pain with other drugs.  It was supposed to be strictly controlled, but questionable marketing practices have resulted in patients being prescribed the fentanyl lollipop to manage conditions such as chronic back pain, knee pain, head aches and other problems for which the benefits of the drug do not outweigh the dangers of Actiq side effects.

>>INFORMATION: Actiq lollipop overdose and deaths

Actiq lollipop side effects could result in dental problems, addiction, overdose and death.  Many users who suffered serious injuries as a result of the pain medication, could have prevented problems if doctors were not misled.  Even though the Actiq lollipop is only supposed to be prescribed for management of cancer-related pain, today, cancer patients only account for a very small percentage of all prescriptions for the pain killer. 

LAWSUITS OBTAIN COMPENSATION BUT DO LITTLE TO DETER ACTIONS

While the drug makers profit from off-label uses of dangerous drugs, such as Actiq lollipops, many patients suffer significant physical injury.  Many victims pursue lawsuits to obtain compensation for their injuries which could have been prevented with proper research and warning.  However, most pharmaceutical companies continue to find that there are profits to be made even after paying verdicts for injured consumers.

The request for information from Rep. Waxman will hopefully lead to actions which will deter drug makers from placing profits before patient safety.  Currently the fines which are collected after drug manufacturers are found to have conducted improper marketing or research do little to change the company’s actions, as they have no real impact on the corporation’s earnings.

The manufacturer of the Actiq lollipop is one of five different companies which have received letters from Rep. Waxman.  The following corporations are also being reviewed as part of this investigation:

FREE LAWSUIT EVALUATION

The lawyers at Saiontz & Kirk, P.A. are currently investigating potential lawsuits against the manufacturers of Actiq, Zyprexa, Seroquel and drug eluting stents.  Individuals who were injured by side effects of these dangerous drugs and medical devices may be entitled to financial compensation.  Request a free claim evaluation.

5 Comments • Add Your Comments

  • ONIL says:

    i had an infection in and around my neck from C1 too T4 i now have rods up and down both sides of my neck .after going to many so called docters i was told my pain is all in my head or your “DRUG SEEKING”
    not untill i went parlized from my neck down my left side too my left arm i went to the ER and they could find nothing long story short after having 5 neck surgerys in a halo two time and years of strong iv antibiotic infection was “MERSA”pain at 10 all the time opana80bid,kadian200bid,methadone30q6,actiq1200,and opanaIR around the clock iwas starting get out of bed and having a life after 4 years of hell you tell me if im not in just as much pain that a cancer pt is in i should be able to have actiq but as of last week i guess because of all the lawsuite my insurance company “BC/BS”after being on this med actiq for 4 years stated to me that actiq is only for pt that are in a lot of pain
    ie moderate to severe or (cancer pain) i guess no else has severe pain

    Posted on May 6, 2009 at 2:41 am

  • Sailbum says:

    ONIL – I agree with your sentiments 100%. I also do not have cancer but deal with severe pain. After multiple surgeries on my cervical spine, I was told there was nothing more they could do. Due to delays getting surgery when I needed it caused by HMO rules, I wound up with permanent spinal cord damage. I have not been on Actiq, but I feel that doctors should be able to prescribe what they feel is best, without interference from insurance companies. I am hoping that this note gets to you, since I do not see an e-mail listed. I am seeing a pain management doctor who has put me on a different kind of ‘lolipop’ that is a compound of Ketamine and Dextromethorphan after the opiods stopped working effectively. You may want to talk to your doctor abiout trying this. There is a lot of research on-line that you can look at.

    Posted on May 16, 2010 at 6:02 pm

  • David says:

    I have lost many teeth to this drug & had lots of damage to my life.

    Posted on December 9, 2010 at 12:09 am

  • connie says:

    i have been using actiq for over ten yearsi was reciving 1600mg of the med. but when i went to refill my med i am told it is no longer avable for me i have lost my teeth and it is the actiq that took them but it was a little price to pay see befor the actoqs i was in bed most of the time in so munch pain i could not get out of bed with the help of the actiq and morphone i was able to get out of bed and be the mother of five children as i had always wanted to be two of my sons became presidential scholars i agree that people should be told of the side affects to using actiq but for me my teeth was a price i would and have paid to be able to have a life of little pain now with out the actiq im in bed again crying god i dont care about my teeth i just want the pain to stop i dont unstrand how cold these people to take away the only med that work for me … please i cry please top this pain i want to live to go shopping to play with my grand children but i hurt so that all i can do is lay in bed crying in pain

    Posted on March 23, 2012 at 4:18 pm

  • David says:

    My wife suffers from RSD which is a severe chronic pain condition that she will have to manage for the rest of her life. This pain is rated higher on the McGill pain index than severe cancer pain. This pain can be reasonably controlled by Fentanyl Patches, but it has a particularly nasty problem that if patient experiences a “breakthrough” pain, the pain can run out of control and they will require various forms of surgical nerve block (e.g. Stellate Ganglion Block) to bring the pain back under control. In my wifes experience, the only medication that is effective in controlling the breakthrough pain is Actiq. Due to the Fentanyl patches, she has a long term tolerance to opiods and had been using Actiq for almost 8 years without incident. She typically requires only about 4-6 lollipops /month on average, but due to various actions by the FDA, she now cannot obtain the prescription at all.
    It does not take a scientist to understand that from the perspective of the patient, severe pain caused by cancer is absolutely no different than severe pain caused by RSD and in fact sometimes the “cancer pain” is severe BECAUSE it induces RSD. Yet the FDA have decided that a patient can only get access to Actiq if their pain is caused by cancer.
    However, as a scientist, I can with 100% confidence say that the claims put forward by the FDA regarding Actiq are completely bogus science, although I understand their concerns to prevent it from being abused by people who do not require it or can be harmed by it.. I have been trying to obtain information from the FDA re. the “validity” of the science behind their decision. To date, the FDA have been completely obstructionist and refused to provide me with
    1.detailed information on the “clinical trials” they reference ,
    2.the qualification of the individuals who decided to impose this restriction
    3.,the medical justification for distinguishing between cancer induced pain and neuropathic pain.
    4.why they have concluded that making Actiq available to cancer patients is any safer than making it available to patients with chronic pain conditions.
    In addition to my own findings, the University of Maryland Kernan pain clinic has also expressed their concern about this decision by the FDA.
    At this point, I am 100% committed to supporting my wife and I am weighing up my next steps, but frankly given the fact we are dealing with Federal bureaucrats, I’m not sure there is any alternative to legal action against the FDA .

    Posted on January 8, 2013 at 10:20 pm

Add Your Comments

  • Have Your Comments Reviewed by a Lawyer

    Provide contact information below and additional private comments if you want an attorney to contact you to review a potential case.

    The information below will not be published to this page.

  • NOTE: Providing information for review by an attorney does not form an attorney-client relationship.

  • This field is for validation purposes and should be left unchanged.