Askanesthetician's Blog

An esthetician explores skincare issues and concerns

Why was Accutane Taken Off the Market? January 20, 2010

Filed under: Acne,beauty,Skincare products — askanesthetician @ 11:59 am
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I was very surprised to learn a few months ago that Accutane had been taken off the market.  As I wrote in the “about” section of this blog I suffered from terrible acne as a teenager; my acne was “cured” by a dose of Accutane.  At the time I took Accutane I knew nothing of the potentially terrible side effects, and I was ecstatic with the results.  Yes, I had some unpleasant side effects while I was using Accutane but only while I was using it.  My face turned very, very red and became extremely dry and flaky.  My lips were very dry as well.  Those conditions were embarrassing but no more embarrassing than my acne, and once I finished taking the Accutane my skin was blemish free and no longer dry.  Accutane is considered the last resort in acne treatments because it is so strong.  But Accutane is also the only known “cure” for acne making it, in my opinion, irreplaceable.   

 Additionally, it is important to point out that there are great emotional and psychological side effects of acne, especially severe acne.  Having acne takes a terrible toll on your self-esteem.  Everyone wants to have blemish free skin, yet not everyone seems to be able to achieve it.  I am not talking about getting a occassional pimple around your period but about acne that is wide spread, unattractive, and immediately apparent to everyone who looks at you.  When you have acne in some ways it feels like the whole world has beautiful, clear skin but you.  You become upset enough about how your skin looks that you begin to consider using just about any treatment, cream, dietary supplement, or lotion that is marketed at those suffering from acne.  And then when nothing works you get more depressed about how you look.  The great thing about Accutane is that it can  both help you achieve blemish free skin and help you regain confidence and self-esteem.

What is Accutane?

Accutane (generic name isotretinoin) was first introduced in 1982 and is an oral drug derived from vitamin A.  Essentially Accutane stops oil production in the sebaceous glands and then shrinks those glands.  After this happens sebum cannot clog the hair follicle which sets off the chain of events that eventually lead to breakouts.  Additionally, Accutane decreases cellular buildup in the follicles, kills the acne bacteria, and even controls inflammation.  Once treatment is complete normal oil production returns and sebaceous glands slowly grow larger again, but they never return to be as large as they were originally.  But what is remarkable is that after using Accutane most acne sufferers never experience the level of break-out that they did before taking the drug.  As such it is the closest thing that can be considered a “cure” for acne.  The Food and Drug Administration approves Accutane for the treatment of “severe recalcitrant nodular acne” – in other words acne that is characterized by many inflamed nodules and cysts that are found deep in the skin.  Doctors today may also prescribe Accutane to patients who have acne scars or have a tendency to scar. 

The most common side effect from taking Accutane is very dry and irritated skin.  The single most common side effect is excessively dry lips – up to 95% of Accutane patients have this problem. Other side effects include mild nosebleeds, hair loss, aches and pains, rash, increased sun sensitivity, and headaches.  And those are the temporary side effects.  More severe, though less common side effects, include nausea, depression, severe stomach pain, increased cholesterol levels, and yellowing of the skin.  Of course, the most disturbing problems associated with Accutane are very severe birth defects.  The risk of birth defects are extremely high if the mother was taking, even a small amount of Accutane, during her pregnancy.  Birth defects include heart, brain, and central nervous system defects, abnormally small or asymmetric heads, cleft palates, deformed eyes or ears including infants being born without ears.  Accutane babies generally have severe developmental difficulties or can be born mentally retarded.  Because of these severe birth defects doctors are cautious about prescribing Accutane to women of childbearing age.  If the doctor does decide to prescribe the drug the woman must undergo pregnancy prevention counseling and have two negative pregnancy tests before being given the prescription.  Prescriptions are only given on a month by month basis and are only reissued after a negative pregnancy test is obtained.  There has been much talk about a link between Accutane and depression, but the number of suicides of Accutane users and those hospitalized for depression are very small when compared to the millions of people in the US who have used Accutane without a problem since its introduction in 1982.

Despite the harsh side effects and the very upsetting birth defects that can occur because of Accutane this drug has provided lasting relief and help to millions of acne sufferers.  Though these side effects should not be dismissed lightly the benefits of Accutane must be highlighted.  Accutane has proved to be the cure many people have sought for their severe breakouts.   

Why was Accutane Taken Off the Market?

Accutane was manufactured by the drug company Hoffmann-La Roche Inc.  Hoffman-La Roche Inc. said in a statement that they pulled Accutane from the market because of “business reasons“.   Indeed Accutane, when it was pulled from the market, only made up 5% of the isotretinoin product sales.  But perhaps more tellingly Hoffman-La Roche has and continues to fight lawsuits brought by patients who suffered some of the more extreme and terrible side effects of Accutane.  The newest lawsuits against Hoffman-La Roche involve plaintiffs who developed Inflammatory Bowel Disease (IBD) after using Accutane.  A simple google search to  find out information about lawsuits involving Accutane turns up over 350,000 hits.  There seem to be plenty of law firms out there who are willing to take on such a case.

So now that it seems pretty clear why Hoffman-La Roche Inc. pulled Accutane from the market what is someone to do who suffers from severe acne and who has tried lots of different treatments to no avail?   Even though Accutane is no longer available generic versions of the drug are.  Three such generics are currently available:  Amnesteem™, Claravis™, and Sotret®.

Bottom Line:  Judging by my own experience with Accutane would I recommend its use?  Definitely, but only if you are under the direct and constant supervision of a doctor.  Your doctor should educate you on the side effects and risks of taking a version of Accutane, but you should be sure to educate yourself as well.

Here are two great resources for more information about Accutane and about acne in general:

http://www.acne.org/accutane.html

Breaking Out by Lydia Preston

For some new research about Accutane see my post:  New Information About Accuntane

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5 Responses to “Why was Accutane Taken Off the Market?”

  1. David Says:

    I’m completely with you. Without Accutane, I have no idea how long (probably forever) I would have suffered the severe acne I had as a teen. I had been on nearly every drug prior to Accutane as my doctor would only use it as a last resort (my father had used it too once upon a time). Now I see my son growing up and can already tell he will suffer the same issues I did. Accutane off the market doesn’t sit well with me. Everyone knows there is side effects, it’s very clear prior to taking it. Most people only have the effects you mentioned. For me, it was dry lips, well worth it for clear skin. This is why dermatologists see you regularly while you’re taking it. It is the magic pill that gets right of acne.

    It sucks that everyone has to sue when they get a tummy ache. If you start having side effects that you can’t handle, stop taking the drug.

  2. Kristen Says:

    Your experience with accutane was nearly identical to mine. All drugs have a risk of side effects. Accutane was very clear about what theirs are. I am so very grateful for this drug, and the pros greatly outweigh the cons.

  3. Bryan Says:

    Umm….have you guys been under a rock!! This stuff is horrible for you!! People are a having there colon’s surgically removed and are having severe incurable IBD amongst many other things due to accutane. You may want to rethink using it. I would be far more embarrassed if i couldn’t even sleep longer than two hours at a time with my GF or BF due to chronic debilitating incurable diarrhea for the rest of my life! Accutane is under a full blown class action lawsuit over the many it left with lifelong negative effects. I would trade acne any day…

  4. Bryan Says:

    Oh and one other thing…those “most common side effects” are generally based on pre released tests conducted before being put on the market…….the LONG TERM side effects are not known until long term users contract them! So always be weary of what your taking.

  5. leanne Says:

    im sorry but i totally disagree with brain, i took Accutane 5 years ago and i had the most severe seborrhoea (excess sebum) and bad acne, all over my face back and chest and all i can say was that is completely destroyed my life before i took Accutane i was a recluse, became severely depressed and can go as far to say i was thinking of suicide. Before the acne developed i was the kindest most sociable person u could meet who loved life and seeing my friends Ino that’s really bad when i look back now that i thought of suicide but acne can seriously mess with your head. Nothing i tried worked my skin was literally soaking in oil. And personally even if i did experience the severe side effects i wouldn’t sue, because it literally saved my life. if your partner truely loves you they would understand your condition of the bowel condition some users have developed, but mostly the rest of the world are not aware of it when you have abnormal acne every1 u see including people you dont know are aware of it when i went for my accutane consultation i had no makeup on and literally i got so may stares and even one women behind me said OMG in shock personally i think these people are rude it can happen to anyone including them so they should think before they point and stare really annoyes me sorry for the rant lol 1 year after i took it the sebum returned about 30 present so my skin is still oily but NO WAY NEAR as bad it is bearable and i have the occasional pimple around my period. So for me it is essentially a cure, no other medication could have done this for me. I highly recommend Accutane and maybe the users that have developed severe side effects maybe their acne was not that bad or it didn’t really bother them to the point of thinking of suicide, because i can say for sure i wouldn’t sue no matter what. THANKU ROCHE. 🙂 Good luck people


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