What is Accutane?

Oily and acne prone skin are challenges of most of the people. One of the solutions offered has been Accutane.

Accutane is also known as isotretinoin. In some parts of the world it is also sold as Roaccutane. It is a derivative of Vitamin A given orally in a pill form to patients with severe acne. At first it was prescribed to people with severe acne who did not respond to other treatments. In recent years, Accutane has been prescribed more frequently not only for severe acne but also people with less severe acne (1-3).

How does Accutane work?

The exact cellular mechanism of how Accutane works is not yet clear, but studies show it could work in 4 possible ways.

1. It markedly decreases the size of oil glands of the skin. It also decreases the oil (sebum) production around 80-90% from these oil glands (4-5).
2. Decrease in oil production of the skin leads to decreased levels of bacteria that cause acne (P. acnes).
3. It also reduces the production of skin cells inside the pores, which decreases the clogging of the pores.
4. It has been shown to have anti-inflammatory properties (6).

Severe side effects?

Although it can treat cystic or severe acne, Accutane is not a medicine that can be taken lightly.

Short-time side effects:  could include dry lips, dry skin, nose bleed, rash, increased susceptibility to sunburn, or abnormal menstruation.

Long-term effects: Accutane use can result in severe birth defects. It is considered as a teratogenic chemical. Studies showed that 42 percent of infants from Accutane-exposed pregnancies suffer from birth defects such as internal and external abnormalities including cleft palate, missing ears, facial dysmorphism or central nervous system malformations (7). Therefore, it should not be used during pregnancy or one should avoid pregnancy when using this drug.

In addition to birth defects, Accutane users could experience liver damage, inflammatory bowel disease or Crohn’s disease causing the patients to suffer from the symptoms for years (8-9).

Accutane Recall

Roche initiated an Accutane Recall in terms of the U.S. market with eleven other countries on June 29, 2009. Currently, Accutane is not sold as Accutane but sold in the generic names like Sotret, Claravis, etc. The drug is distributed by a Federal government program known as IPledge. Although the name is different, the active ingredient and side effects of the drug are still the same! Only a  prescribing physician in this program could provide this medicine now.  The Accutane users who developed inflammatory bowel diseases (IBD) including ulcerative colitis and Crohn’s Disease due to accutane use filed thousands of lawsuits against Roche. As of 2010, makers of Accutane have lost majority cases gone to trial with jury awards of $56 million in total. To date there are still cases filed about Accutane side effects.

Scientific References

1-Oral isotretinoin: an analysis of its utilization in a managed care organization. Chen K, et al.  Journal of Managed Care Pharmacy. 2002; 8(4): 272-7.

2-Use of isotretinoin (Accutane) in the United States: Rapid increase from 1992 through 2000. Wysowski DK, Swann J and Vega A.  Journal of the American Academy of Dermatology. 2002; 46(4): 505-9.

3-The role of isotretinoin in acne therapy: Why not as first-line therapy? Facts and controversies.Rigopoulos D, Larios G and Katsambas AD.  Clinics in Dermatology. 2010; 28(1): 24-30.

4-13-cis-retinoic acid induces apoptosis and cell cycle arrest in human SEB-1 sebocytes. Nelson AM, et al. Journal of Investigative Dermatology. 2006; 126(10): 2178-89.

5- Low dose isotretinoin combined with tretinoin is effective to correct abnormalities in acne.Plewig G, et al. Journal of the German Society of Dermatology. 2004; 2(1): 31-45.

6-The use of isotretinoin in acne. Layton A. Dermatoendocrinol. 2009 May;1(3):162-9.

7-The use of isotretinoin in the treatment of acne vulgaris: clinical considerations and future directions. Leyden JJ, Del Rosso JQ, Baum EW. J Clin Aesthet Dermatol. 2014 Feb;7(2 Suppl):S3-S21

8-Isotretinoin, pregnancies, abortions and birth defects: a population-based perspective. Bérard A, Azoulay L, Koren G, Blais L, Perreault S, Oraichi D. Br J Clin Pharmacol. 2007 Feb;63(2):196-205.

9-Continued occurrence of Accutane-exposed pregnancies. Honein MA, Paulozzi LJ, Erickson JD. Teratology. 2001 Sep;64(3):142-7.