Accutane Pulled from Market Amid Lawsuits, Increased Generic Competition

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Accutane is being pulled from the market by its maker, Roche AG. According to the Associated Press, Roche said the decision to withdraw Accutane was made for economic rather than safety reasons. But as anyone who reads this blog known, over the past couple of years, Roche has lost several Accutane lawsuits, and been ordered to pay more than $33 million to people who claim they were injured by the drug.

Approved by the Food & Drug Administration (FDA) in 1982, Accutane has been the subject of controversy for years. It first garnered attention in the late eighties for causing severe birth defects. It has also been known to cause psychiatric problems, and has been linked to hundreds of cases of suicide in the United States. Accutane has also been associated with problems of the liver, kidneys, central nervous system, and pancreas, as well as the cardiovascular, musculoskeletal and auto-immune systems.

Most recently, Roche lost several Accutane lawsuits brought by people who claimed the drug caused them to develop inflammatory bowel disease (IBD). In November 2008, a New Jersey jury ordered the company to pay $13 million to three such plaintiffs. The previous April, another New Jersey jury awarded $10.5 million to a woman who blamed the drug for her ulcerative colitis. In May 2007, another New Jersey trial resulted in an award of $2.62 million to a patient who needed to have his colon and most of his rectum removed after taking the drug. In October that same year, a Florida jury awarded $7 million in damages to another Accutane user who developed the IBD.

In announcing its decision to pull Accutane, Roche did cite the high cost of product liability suits – it currently faces 5000 such lawsuits – involving the drug. But according to Bloomberg.com, the company also said a reevaluation of its product line had shown Accutane faced serious competition from generics.

Roche said Accutane will be pulled in the U.S. and 11 other countries. The last date for distribution in the United States was June 25. According to Reuters, Accutane is now no longer available from Roche directly but patients may still be able to get it from pharmacies.

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11 Responses to “Accutane Pulled from Market Amid Lawsuits, Increased Generic Competition”

  1. Comfy Tummy Says:

    Is this article true? Is no one taking into account that the people who took Accutane most likely also were prescribed antibiotics from their dermatologists and that long term antibiotic use can cause colitis and IBD? It happened to me and I was never on Accutane. My dermatologist prescribed antibiotics instead – for 16 years! When I got off the antibiotics, I ended up with severe IBD because it had totally disrupted the normal and healthy balance of bacteria in my intestines. Someone really needs to do more research on this topic. I don’t see how Accutance could cause IBD. To learn more about my story, visit my blog at http://www.comfytummy.com

  2. sally riker Says:

    i was taking actos for a while since 10/25/06 and in 11/07 i was diagonoside with ulcerative colitis. I am still suffering tremendously and heard this may be a side effect of this medicine, is their anything i can do about this and who do i contact.

  3. mike Says:

    sally yes you need to contact a new jersey lawyer advertising accutane representation. join the thousands of us who got ulcerative colitis from the drug.
    some of us had to have our colons removed.
    it is danger drug and roche knows it. this is another sign that they are losing.
    the fda should’ve banned this drug years ago

  4. John Says:

    God bless these Attorneys!!!

    This drug has ruined many peoples lives. I took this drug has my MD told me all the side effects are lies and it’ll work great. I trusted him and my life has never been the same. My face is always red, horrible dry skin, mental side effects and blood in stool. I wouldn’t take a medication again ever, they are all horrible!

  5. Shane Says:

    What about all the people the drug has helped? I would have most likely ended up killing myself from looking so horrible with my severe acne. No joke, if accutane did not work that was plan b.

  6. Lita Says:

    Agree with #5. I don’t know what my daughter would have done if this drug had not been available. Her father had severe acne and took Accutane back when it first came out, after many years of already having acne and being scarred. If my daughter ended up with that complexion, I am pretty sure she would feel the same as Shane.

  7. To Shane Says:

    I have a feeling we will see Shane here complaining when he has his first IBD flare-up…

  8. mike Says:

    My MD strictly monitored me for any abnormalities. This drug, while harsh, changed my life and my confidence. Like any other drug it had side effects, but i will forever be greatful for this drug and what it did for me.

  9. Venus Says:

    I agree with # 5 and 6 the i was on the drug for 6 months. I was 29 at the time and i am doing good i also had to get checked every month by my doc to make sure i was feeling good and nothing out of the normal was happening to my body… It is a great drug but is had alot of really bad side affects and growing up with acne is hard when your a kid or even a young person… It all depends on how your budy deals with it. Now my skin looks good no dry skin no dry lips no nothing really… The drug has great intenions but just bad side effects… I would have any of my friends use it if need be just get checked every month… This drug is not all bad guys it has changed my life and many others. We feel better about our selves and not sad or feel ugly due to breaking out 247 trying to cover it up… It may work for some and may not work for others…

  10. Christina Says:

    I also took this medication for 6 months and it changed my life. I knew what the side effects were and was monitored monthly by my doctor. I talked to all of my friends and asked them to help monitor me for mood swings, which did occur. I stocked up on Aquaphor for the dry skin and lips, which was worse then expected but I never thought anything would take away my acne and after years of trying everything under the sun this worked! And just like #1 stated, any long term treatment with antibiotics can cause the IBD side effect. People are too easy to sue instead of paying attention and doing their homework on medications doctors put them on. There is no such thing as a safe drug, even advil has side effects. Do your homework and stop blaming everyone else. This drug worked miracles and it truly is a shame it’s been pulled.

  11. Mark Says:

    Thank god this drug has been pulled. Sure, this drug helped people. And drinking bleach can cure AIDs too.

    I am blown away that the FDA ever approved this drug. For those of you who complain about the “bad side effects” but then talk about the “great benefits”, try having your colon removed. That one doesn’t go away folks. It hasn’t happened to me, but I’m one of the lucky ones. I started developing IBD symptoms a few months after taking the drug (and to the people who feel that somehow eliminates plausible causality, spend about 5 minutes researching immune-mediated diseases).

    There are plenty of better options for acne. Try topical tretinion! No one is stupid enough to take this drug… or so I thought before I saw the posts on this page. I took this drug just after it was released because I had a parent who was more concerned about my appearance than my general wellbeing.

    There are some sick people out there. The removal of this drug is a great day for common sense and for the many who developed IBD in the aftermath.

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