Accutane exits the acne market

Welcome Guest! Login | My Account | My Saved Articles

Accutane exits the acne market

Posted Wednesday, July 08, 2009

After multiple verdicts awarding millions of dollars in damages to sickened patients, Roche is pulling its controversial acne drug Accutane from the U.S. market.

Prescribed for severe acne, often as a last resort, Accutane received FDA approval in 1982. Over the years, it gained a reputation as a high-risk medication with potential side effects such as birth defects, depression and suicide. Most of the lawsuits involved patients who reportedly developed inflammatory bowel disease as a result of Accutane use, their cases underpinned by claims that they were not sufficiently warned of the risk.

Roche, however, says their decision to discontinue American Accutane sales had nothing to do with health hazards.

"Roche stands behind the safety of Accutane and the rigorous risk-management program Roche developed over decades of cooperation with the FDA," a spokesperson said in a statement. Instead, they point to the financial impact of generic competition as the key factor.

Accutane had already been pulled from the market in Austria, Denmark, France, Germany, Norway, Portugal and Spain.

Tell us about your personal Accutane experience by leaving a comment below.

Tags: Accutane, acne, birth defect, cystic acne, depression, FDA, inflammatory bowel disease, medication, prescription, side effects, suicide

View Comments (27) | Send | Save

Comments

27 Total Comments | Post a comment

anonymous said...
I used accutane in 1988 my lips bled all the time so I discontinued it after a month. 11 years later the area around my nose peels for no reason!

Posted July 13, 2009 7:19 AM

valerie said...
It's a pity to hear this. Accutane was a godsend for me. The depression that severe acne causes out weighs the risk of developing depression with the use of Accutane. But, as I understand, the risk associated of developing depression with the use Accutane, is very small. The risk of birth defects while using Accutane is widely documented and frankly, shouldn't be taken by any irresponsible party. I hope that there is another product out there that teens can use safely and effectively. Teens have enough hardships growing up without the added pain of severe acne.

Posted July 13, 2009 8:28 AM

Diane said...
I loved being on Accutane. Yes, there were numerous lab tests while I was on it, but that was one of the implications of being on it, no big deal.
My face never looked better, my make-up stayed on and was perfect all day long and my pores were nowhere to be found.
Unfortunately, my dermatologist said she did me a disservice by not prescribing a strong enough dose as it didn't solve the problem. (It worked beautifully for my brother and sister, though.)
But while I was on it, I was thrilled. No lasting side effects from it.

Posted July 13, 2009 9:10 AM

arym said...
I had a severe case of cystic acne starting in my teens and continuing on to my late twenties. When accutane became available I was nearly thirty years old. Thank God for accutane, it cured my acne and I experienced only dryness as my worst side effect which was a great trade off from having painful cyst which only went away if they were injected with steriods. Unfortunaly I already had severe scarring which took me twenty years, many procedures and allot of money to improve. My children also took accutane in their teens because I did not want them to suffer as I had.

When I took accutane it had just came out and there were not the strict regulations as when my children took it. I understand the importance for such strict guidelines because of the potency of this drug but I am very sorry that it is being taken off the market in the U.S.A. because so many will continue to suffer disfiguring acne with no cure.

Posted July 13, 2009 9:39 AM

Kelly said...
I absolutely loved it...I was an adult and mine just kept getting worse or was worse as an adult. While on it my skin looked great, my hair was less oily. Of course I read and was aware of the side effects. But was prepared. Nothing out of the unexpected happend other than I felt and looked better.

Posted July 13, 2009 12:04 PM

Susan said...
This is very sad! Accutane did wonders for me! I had severe acne as a teenager and had tried everything! Accutane was the only thing that cured my acne and made me feel good about my skin. Yes my skin and lips were very dry but that was expected. Yes I was depressed but I don't believe it was from the Accutane...i believe it was from having acne....but in the end I owe soooo much to Accutane! I feel very bad that people with severe acne will not be able to use it. It has amazing results.

Posted July 13, 2009 1:12 PM

Jody said...
Accutane was a miracle drug for me I did a 6 month regime in 1987, yes I has dry lips and a bit of sun sensitivity which was good for me later in life less sun damage now that I'm 38. I had severe acne on my face, chest, and back. I tried everything and finally my senior year my dr put me on Accutane. It worked miracles on me and I'm so glad I was put on it. Jump ahead 21 years my teenage son started having bad break outs with swelling, it was ruin his self esteem and his looks, we tried many different things trying to clear his skin up but nothing worked. So his derm and I desided to go with Accutane. We talked to him and told him that there could be some side effects. He still wanted to go ahead. I made sure to keep check on him asking him questions about how he felt was he having any problems. I also gave his school teachers copies of side effects of the drug and asked them to keep an eye out for behavior changes. He did well and has had no regrets. I stand behind Accutane

Posted July 13, 2009 2:19 PM

Suzy said...
This is a travesty. Without Accutane, people with severe cystic acne have no effective treatment for the destruction of their skin. Thanks to all those greedy litigants and lawyers and ridiculous jury awards, another good medication is gone from the market. Doctors and consumers knew Accutane was a powerful drug and only to be taken by patients who really needed it and were healthy enough to take it. It's common sense that any drug strong enough to cause birth defects is strong enough to cause other problems. The people who sued would rather have other people suffer with cystic acne.

Posted July 13, 2009 2:24 PM

PA said...
This is very sad. I went on accutane when I was fifteen and nothing else would work and it saved my life! I am also a Physician Assistant specialized in Dermatology and i have watched patient after patient recieve unbelievable results when nothing else would clear their scarring, life inhibiting acne. I've never had a patient get suicidal or have abdominal issues. Everyone experiences dry skin, however, this does subside after discontinuation. Accutane is the only drug that works for so many people struggling with disfiguring acne and I think it's a crime to take the option away.

Posted July 13, 2009 2:52 PM

obie said...
Now, I hope, the three generic brands do not follow suit!
As far as I have read, only Roche is removing their product from the market.
the pantent expired in 2002 and three other brand names came out with their generic versions at a MUCH lower cost, causing Roche to only have about 5% of the market.
I hope for teenagers everywhere, this drug continues to be available, as it is the ONLY drug that works at the root cause , instead of treating it after your face is scared and covered with sores......

Posted July 13, 2009 6:22 PM

anonymous said...
I am a psychiatrist and at my urging, my daughter's dermatologist put her on Accutane. It`was a Godsend for her, as it was for many of my patients. I never saw a case of depression related to Accutane. Depression from acne, yes...but never from Accutane. When the generic became available, she tried it for one month and it did nothing! We returned to Accutane (paying much higher prices than before the generic was available) but the branded product worked. What a crime that such a successful medication was pulled from the US market! As I have seen in my own practice, it all comes down to money...what the insurers can save and what attorneys can collect! Somehow the patient is always left out of the equation....

Posted July 13, 2009 9:50 PM

Nikki said...
Accutane was the only thing that controlled my painful and humiliating cystic acne. After years of being multiple dermatologists' guinea pig, prescribed countless useless antibiotics and creams, I finally found a doctor who would prescribe accutane for me. I only wish I had found him before my face had been so badly pitted with scars, but it could have been worse. Four years later, I still have breakouts during the summer and when I'm extremely stressed, but it's nowhere near as severe. I feel sorry for those who no longer have Accutane as an option now.

Posted July 13, 2009 10:03 PM

View My Bio

Dr. Laura E. Skellchock | Dermatologist
I have prescribed Accutane innumerable times for severe, scarring acne or acne which would not resolve with any other more conservative treatment. My patients consistently obtained excellent results, with very little side effects - because we prevented side effects by proactively treating dryness, making sure they didn't drink alcohol, and making sure they were responsible enough to not get pregnant. There is no other medication that works for widespread, scarring acne. I hope the generics will still be available for us to use in the future.

Posted July 13, 2009 11:39 PM

Gretchen Murray said...
Too bad this medicine saved my skin and I am soooo grateful. I too have IBS, maybe it is a result but to me a small price to pay and IBS is so easily treatable. If you were to tall me at the time that I was going to have 100% IBS, I still would have done it and so would most of these people trying to make a buck....when you are that serve with acne all you want is your face to be normal!!

Posted July 14, 2009 4:24 PM

ncphottie said...
I am glad they are pulling Accutane out of the market! I used it twice in my teens, and it did nothing for my cystic acne. But yes I blame my anxiety and depression on the medication. If I would've known it had a psychological side affects, I would not have taken this medication. I did however try natural holistic methods, especially changing my diet, and that DID help with the cystic acne and many more things. So I am happy that this terrible medication will not harm many more people!!!

Posted July 14, 2009 10:03 PM

Jennifer K said...
Well I am very dissapointed to have read the news of pulling accutane off the market...I have an appt. with my doctor tomorrow, and I was planning on getting a script for my cystic acne!!! I just hope there will be another option in treating acne internally.

Posted July 15, 2009 11:32 PM

anonymous said...
I love Accutane - used it twice in the past 15 years and would highly recommend it. The generic name is Isotretinoin/Tretinoin and it is still available under other brand names such as Sotret. Just an FYI, some people experience unpleasant side effects or toxicity while on Accutane when they unknowingly consume Vitamin A in their foods and vitamin supplemnts - Vitamin A potentiates Isotretinioin/Tretinoin. I use a new vitamin called BtoZinc - complete multi-vitamin and no Vitamin A. Watch out for added Vitamin A in some brands of milk, cereals, etc.

Posted July 20, 2009 11:01 AM

anonymous said...
Accuntane was a MIRACLE drug for me.
I had suffered for years with the most disfiguring cystic acne...if anything causes serious depression and embarrassment, it's having a pimply face.
What a shame that irresponsible users and their greedy lawyers have destroyed the availability of the only legitimate acne cure on the market.

Posted August 10, 2009 5:01 PM

Mom said...
My son was put on Claravis (generic) in January. Initially we saw no results but in the third month his cystic acne was CLEAR. He was ecstatic and I have never seen him happier. In April he began getting extreme intestinal aches and could not keep food down. Numerous doctor visits and CT scanes identified a swollen intestinal lining and it was blocked in three places. The boy hadn't been able to eat food for a month and threw up constantly. It turned a healthy boy into one who we hardly recongnized. He lost 20 lbs as well. HE was diagnosed with Crohns Disease which the doctors (dermatologist and gastroenterologist) said was most likely the cause. He also became anemic. He was devastated because this medication was a miracle for his skin which showed no response to other treatments. After a month of being off the medication he begged to be put back on because his skin was becoming full of acne again. The medicaiton was out of the question. He now has to have IV infusion treatments.

Posted August 16, 2009 3:14 PM

Lindsay said...
I am so glad to hear this! I am left with horrible scars on my skin that I have been trying to treat for 7 years as a result of using accutane.

Posted October 27, 2009 7:47 AM

anonymous said...
Acutane was amazing and completely removed my acne. I see a lot of comments about people complaining of the side effects such as severe dryness... you knew that was going to happen when you agreed to take the medicine so don't complain about it now. Yes, the dryness and peeling was uncomfortable, but it was totally worth it.

Acutane did not make me feel depressed while I was on it. Actually I feel like I have more mood swings now that I no longer take it

Posted October 28, 2009 3:42 PM

Pam in South Africa said...
I'm currenty on Roaccutane and trust me ma skin has never looked better. I'm sorry that many teenagers in the USA will never expiriance the feeling of looking beautiful after yrs of trying to fight acne with no success. Yes the side effects are there and are very server but it really needs one to responsibility and just be wise when using it. And also listening to ur doctors. I'm glad they not taking it out of market in South Africa

Posted November 14, 2009 10:24 AM

Female, 39, Midwest said...
Back in 1992-3, after years of several oral and topical antibiotic trials that did not help, I finally begged my doctor to consider putting me on Accutane. He reluctantly agreed, and referred me to a dermatologist that had experience with this medication. The dermatologist explained to me what to expect (which IMO made all the difference for my compliance and outlook) and I only needed one trial of Accutane to CURE my cystic acne, which by that time (I was ~23yo) left many scars, both physically and psychologically. I have never regretted or had any serious problems from it (dry lips and eyes during the treatment, which was pretty minor, and I was already practicing safe sex and had no intention of getting pregnant).

Posted November 18, 2009 12:33 PM

Eileen said...
I took accutane 22 years ago, in 1987. My face had broken out in severe acne at that time and nothing was working. I had some dryness while taking it but my face cleared up immediately. Now 5 kids later I still think it was the best medical decision I made. I have so enjoyed never having any acne again. My 17 year old used accutane 2 years ago and he looks great too. My 20 year old daughter wants to use it now, so this news of it being pulled off the American markets is bad news for her.

Posted December 19, 2009 3:32 PM

Shannon said...
I am so glad accutane is off the market. It caused horrible flaring of my acne and left me scarred for life. My mother works two jobs trying to save up the money for me to have ablative laser treatments. It truly ruined my life. When we contacted Roche, they didn't care. They just said they were sorry, but said they would not help my family that has gone through a horrible financial hardship because of them. There is a nice doctor in Seattle (Dr. Reischel) who is going to see me this spring. I pray she can help me! The thing that bothers me is that when you go on the drug they said nothing about the scarring it can cause, only that they don't want you to get pregnant. They should have warned us. We would never have taken this destructive drug.

Posted February 5, 2010 9:18 PM

Jamie said...
It's certainly a drug that you need to be responsible with, but monitered properly it can have such amazing effects. The 6 months I was on it I expericed dryness and cracking in the corners of my mouth. I also had accutane rash on my arms but it was completely 100% worth it. There is nothing worse than trying to teach middle school, when you're only 5' 110 lbs and look like them, having acne just made it worse! I was so grateful for accutane!

Posted May 27, 2010 12:01 AM

anonymous said...
they must have changed something because my dr wants to put me on it...now im scared

Posted June 17, 2010 10:05 AM

27 Total Comments | Post a comment

Dr. Laura E. Skellchock: Dermatologist

Dr. Laura Skellchock strives to give her patients a natural, rested, more youthful appearance. Whether she's performing a laser procedure, erasing a wrinkle or examining a suspicious lesion, Dr. Skellchock uses an integrative, all-encompassing approach to treat both cosmetic and general dermatology concerns. A proponent of alternative and holistic treatments, she has known Dr. Andrew Weil, a recognized leader in the field of Integrative Medicine, since her medical school days 25 years ago. Even before completing a formal Integrative Medicine fellowship with him, she began incorporating relaxation techniques, energy healing and anti-aging medicine into her daily practice.

Visit Dr. Skellchock's NewBeauty profile.

Do you follow NewBeauty on either of the following websites?
Facebook
Twitter
both
neither