Accutane is off the US market, but Claravis and generic version remain

Millions of people suffer from severe, debilitating acne that does not respond to over-the-counter treatments such as acne washes and benzoyl peroxide, and even acne prescription medications. Ongoing severe acne can cause physical effects such as pain, infection, and scarring, and social and emotional effects such as shame and low self-esteem. According to the Acne Resource Center:

Of the 85% of teenagers (between the ages of 12 and 24) that suffer from acne, 25% will have permanent scars ranging from severe to light. The American Dermatologist Association finds that:

  • 20% of all adults have active acne
  • 60 million Americans have active acne
  • 20 million Americans have acne badly enough to cause scars.

Acne affects people regardless of age, gender or race. While thoroughly treatable, of those who suffer from acne:

  • 11% will see a physician
  • 20% will go to a skin care center
  • 30% will use an over-the-counter medication from a drug store or pharmacy
  • 40+% will do nothing

The concept of 40% of sufferers doing nothing is tragic. Since 1982, we have had access to a prescription drug that treats serious cases of cystic or nodular acne. That was the year isotretinoin, under the trade name Accutane, was approved by the FDA for the treatment of severe acne. Its exact mechanism is not known, but it is thought to limit the production of sebum. Most patients see significant improvement, or remission, after a 15-to-20-week course of treatment with isotretinoin.

The drug was controversial from the start, as it is known to cause teratogenic birth defects. All physicians and patients involved with this treatment must abide by a strict pregnancy risk-management program. Isotretinoin has some other serious side effects, too. Mild side effects involve skin dryness and eye dryness, rashes, headaches, hair thinning, and backaches. More serious side effects include inflammatory bowel disease, alopecia, catacracts, blood glucose problems, and more. Because of these side effects, it is only recommended to treat the most severe cases of disfiguring acne, and patients must pay close attention to side effects.

Availability of the drug has changed this year, resulting in some confusion in consumers. Earlier this year, in July 2009, Swiss drugmaker Roche announced that it was discontinuing its sales of Accutane and moving to delist with the FDA. This was not done for safety and efficacy reasons (although Roche has had to defend itself in many lawsuits), but rather because generics of Accutane (isotretinoin) have been available since 2002 and now dominate the market. Accutane itself had only held on to a 4-5% share of market, and it did not make business sense Roche to keep selling it.

Accutane is still available in many countries outside of the United States. Within the United States, its generic form, isotretinoin, is available, and this drug is also marketed as under several different names within the United States: Claravis, Amnesteem, Sotret are a few of the best-known.

Accutane being retired in the U.S. has caused a great deal of confusion among consumers. Posts on many popular acne-related message boards reveal people trying to compare side effects and benefits of several different brand names that are all essentially isotretinoin. To clarify: there is no difference between Accutane, Sotret, Claravis, or generic isotretinoin except for their makers and packaging.

If your doctor has prescribed a cream instead of a pill, topical isotretinoin is marketed under the trade name Isotrex gel.

If you are one of the millions suffering from acne, know that you do have options, and your condition can improve.

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Comments (7)

Great article. I think many people have a tendency of scratching acne, which can leave permanent scars. You have given great information on the drugs and side effects. Can you comment on natural ways of treating acne. How much effective are those?

I like this site and your information given. I am 31 and have been told by my DR. that accutane was something that may have worked for me but is no longer available and considered unsafe in his opinion. I also dont believe my insurance will cover it. I have large painfull acne some the size of nickels all over my face and at times my neck. I hurt daily and hardly leave my home. Makeup hurts to put on and even the oil-free non-comegenic” stuff seems to feel like a build up not a cover up. I dont know what I will do but I can now at least ask her about the generic form.

Before beginning any treatment plan to remove acne scars it is significant to certify that it is right for you. You may need to consult with your skin doctor before starting treatment to see what they advise based on your particular situation.

I used Accutane in the early 90’s after being on other drugs, creams and nothing worked.  I know this is not typical, but after 3 weeks on this drug my face was clear and i felt great.  My doctor took me off the drug, to this day I have not gotten those cystic acne and very few pimples.  Now, its just dealing with the severe scaring that happened with 5 years of bad acne. 

Amazing article it is very  good for acne i really like and got important information about  acne thanks for sharing  

My 14 year-old son is taking Claravis (two 30mg pills a day for 6 months) at the staggering cost of almost $600 per month. Why is a generic drug so expensive?

Claravis is not generic… ask your doc to prescribe isotretinoin 30mg 2x daily.

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