So what is Accutane? Accutane also known as Roaccutane, Retin A (active ingredient: isotretinoin) is an acne treatment drug which was manufactured by a pharmaceutical company named Roche, but was pulled from the market in June 2009.
It began its controversial life in 1982 and was originally intended for the treatment of brain, pancreatic and other cancers. But later became the blockbuster drug in treating severe acne conditions that no other drug could match, but was also the last drug of choice due to it’s list of potential side effects.
In 2002, Hoffman-La Roche lost its patent protection on the Accutane drug, which saw an increase in generic forms of the drug coming on to the market manufactured by other pharmaceutical companies who wanted a slice of the cash pie.
Although Roche ceased production of the Accutane drug, claiming that they were losing too much money because of lawsuits and generic forms of the drug coming onto the market, it can still be prescribed by or under the supervision of a dermatologist in the UK.
It is also available in the US under the control of a FDA mandate website known as iPLEDGE, which requires dermatologists to register their patients before administration of the drug can be given and dispensed by a pharmacist. In Australia and New Zealand it remains freely available, again under the guidance of a general practitioner or dermatologist despite the appalling list of side effects and growing numbers of law suits.
Even though the drug is intended for more severe forms of acne like cystic acne vulgaris, where other drugs have proven ineffective, it has been prescribed and continues to be prescribed to patients with much milder forms of the condition.
There has been a lot of discussion and debate over recent years about whether Accutane and its generic forms should be removed from the market completely or not because of the many known alarming reported side effects that it can cause. Today, the drug can still be purchased on the internet and are also available in capsule form without a brand name, i.e. as the generic medicine which is the main active ingredient of the drug.
Isotretinoin is generally taken orally for the purpose of reducing the bodies’ natural production of skin oil, known as sebum, which is one of the known causes of acne. The excess oil is caused due to the overactive sebaceous glands that produce the sebum oil to keep the skin moisturised.
Despite Accutanes demise in June 2009, and even though acne patients ceased using the drug to treat their acne years ago, they are still suffering atrocious side effects to this day.
It’s for this reason why there continues to be a growing pool of lawsuits to add to the already large number of over 3,200 lawsuits, by people who are looking to sue Hoffmann-La Roche Ltd for their continued suffering.
Even though the majority of the lawsuits being made are against La Roche, generic manufacturers of the drug are also seeing their fair share of lawsuits coming through, due to people switching when Roche patent protection was lost.
The highest award to date was in 2010 for $25.1 million to a man who was at the time of taking the drug in his twenties. He had been using Accutane for a period of 4 month, but later had to undergo five surgeries for IBD (inflammatory bowel disease) which ended in the removal of his colon. The cause of this was as a direct result of taking the Accutane drug.
There have been many reported side effects by those whom took the drug including Crohn’s disease, ulcerative colitis, birth defects, unintended weight loss, bleeding from the rectum, skin lesions, depression, self harming, suicidal thought and more.
The latter has been probably one the worst reported side effects of taking the Accutane drugs and other generics formulations. La Roche responded to these growing concerns and complaints by health official in 1999 by adamantly telling the FDA that there was no proof or link of suicidal behaviour caused by taking Accutane.
Then in 2000, the FDA openly stated that there were 147 known suicides that could be directly linked to taking the Accutane drug. It was then that Roche decided to place a warning label on the packaging informing people of the possible side effects that could involve depression, rare suicidal thoughts, suicide attempts and even suicide.
In 2002, a congressional committee was held where the FDA informed the committee that they had received over 3,000 reports of patients experiencing adverse psychiatric behaviour with 173 suicides directly associated with taking Accutane.
It was then that La Roche changed the label on the Accutane packaging again to warn of “psychosis, depression and rarely, suicidal ideation, suicide attempts, suicide, and aggressive and/or violent behaviours.”
In November 2004, FDA researcher David Graham testified before Congress that Accutane should be carefully scrutinized to determine whether the drug should continue to be on the market in the United States. Graham describes Accutane as “a 20-year regulatory failure by the FDA.”
In December 2004, USA today stated that Roche had ignored an internal doctor’s recommendation that people who take Accutane be monitored for signs of depression and that a warning be placed on the drug’s U.S. label stating this.
In 2005, a study was published in the American Journal of Psychiatry concerning the effects of Accutane.
The study involved conducting brain scans on 28 acne sufferers.
The 28 subjects then underwent psychological tests to ensure that they were not suffering with depression.
The next stage involved administering to the 28 subjects either Accutane or an antibiotic for four months.
After the 4 months, the subjects underwent a second brain scan which was then compared to their original scan before they were given accutane or an antibiotic.
The results of the study clearly indicated that those subjects who were given the accutane drug were showing signs of decreased activity in the area of the brain that is associated with regulating mood.
“What we can say is that Accutane affects brain function… and the areas that are affected are the areas involved with depression,” said Dr. J. Douglas Bremner, who led the research project at Emory University Hospital in Atlanta.
What are the side effects?
Any general practitioner or dermatologist who prescribe accutane have a patient obligation to disclose adverse events, unfortunately, this is not case today. Many patients discover the side effects only after they have received permanent injuries which many have to live with for the rest of their lives.
Here are some of the side effects (note: many, the rest of their lives):
Possible side effects include:
- IBD Inflammatory Bowel Disease
- Crohn’s Disease
- Depression
- Suicidal thoughts or actions
- Birth defects
- Liver damage
- Hair loss or thinning of the hair
- Headache
- Thinning of the skin
- Eczema
- Acne Flare-ups
- Fatigue
You can get a full breakdown of the side effects and further details here accutane drug
New adverse events are being detected at regular intervals, so the above list is not exhaustive or complete.
So I think, given the overwhelming evidence above, the message is clear:
Avoid Accutane, Roaccutane, Isotretinoin like the plague.
Despite being administered under the control of general practitioners and dermatologists, given the severity of potential side effects, I would not be listening to what they have to say about how it could help my acne. I would take charge of my own health and look for safer and more effective alternatives, as they do exist.
There are better and safer ways to treat acne conditions without having to result to using a drug that has the potential to be so destructive.
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