Accutane Pulled from Market Amid Lawsuits, Increased Generic Competition
Date Published: Monday, June 29th, 2009
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.
This entry was posted
on Monday, June 29th, 2009 at 5:44 am and is filed under Accutane, Pharmaceuticals.
Accutane Pulled from Market Amid Lawsuits, Increased Generic Competition
Date Published: Monday, June 29th, 2009
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.
You can skip to the end and leave a response. Pinging is currently not allowed.
June 29th, 2009 at 10:51 am
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
July 14th, 2009 at 2:54 am
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.
July 26th, 2009 at 9:31 pm
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
August 10th, 2009 at 10:42 pm
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!
September 5th, 2009 at 12:41 pm
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.
October 23rd, 2009 at 2:21 pm
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.
October 30th, 2009 at 5:01 am
I have a feeling we will see Shane here complaining when he has his first IBD flare-up…
October 30th, 2009 at 5:10 am
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.
October 30th, 2009 at 11:19 am
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…
November 2nd, 2009 at 4:06 pm
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.
November 5th, 2009 at 7:41 pm
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.
December 1st, 2009 at 5:26 pm
After reading these messages I feel very fortunate. I haven’t lost my colon but have had IBD for 10 years. I don’t have any faith in attorneys or Roche making this right. I would like to hear from anyone that has information or knows of any resources for patients dealing with these side effects. Are there support groups out there?
February 21st, 2010 at 5:06 pm
I can’t say anything about the rest of you, but my son had severe acne and the dermatologist put his on accutane. He did tell of the side affects and my son does not have IBD, at least not yet, but he was what the doctor has described as chronic hives. Now, the allergist he seen attributed these hives to his consumption of accutane. Now I’m sure knowing he would get chronic hives (which is very uncomfortable for him because he’s an athletic person) he would have stuck it out with acne. He is constantly itchy when it flares up, has to take reactine everyday to control it. The letter was sent to the dermatologist from the allergist specialist outlining that he attributed accutane as the cause of his chronic hives but that part was never ever read aloud to us by the dermatologist. We only found out because a copy was sent to our family doctor. Unfortunately, the reactine doesn’t help him anymore. He will be turning 16 on Friday, and I wonder how long this will go on for….Forever???
May 10th, 2010 at 6:34 pm
It’s all about disclosure, folks. My understanding is that Roche had to pay due to lack of disclosure on the collitis risk. I am one of those who was helped tremendously by the drug. I was sick sick sick, physically, and developing deep skin infections from my acne. Borderline life threatening acne. Accutane worked when nothing else did. It is surely harsh medicine, but reducing options is not the answer. Even if the cost benefit tradeoff was only 51% on average, people should be free to choose the route they want to take.