Isotretinoin (Accutane)

The Drug

Isotretinoin, most commonly known as Accutane, was developed by Hoffman-LaRoche Inc. and approved by the FDA in 1982 as a treatment for severe nodular acne.  In addition to Accutane, isotretinoin has also been marketed as Roaccutane, Amnesteem, Clavarus, and Sotret.

While the precise mechanism of action for Accutane’s success in treating acne remains unknown, the chemical structure closely resembles that of retinoic acid, a natural vitamin A derivative which controls normal embryonic development and the proliferation of cells.  This latter ability to kill rapidly proliferating cells led to an initial push to use isotretinoin as a treatment for certain forms of cancer.  Soon thereafter, the manufacturer serendipitously discovered the drugs ability to combat severe acne. Since its approval, over 13 million prescriptions have been filled, making it one of the most lucrative treatments for acne ever invented.

The Controversy

In June 2009, Hoffman-LaRoche pulled Accutane from the market, citing decreased profits due to the rise of generic forms of Accutane, as well as the cost of defending personal injury claims[1].  These claims resulted from studies linking the use of the drug to life threatening side effects such as, but not limited to: birth defects[2], premature closure of growth plates in developing adolescent bones[3], depression[4], suicide[5], and inflammatory bowel disease (IBD) manifested as either Crohn’s disease or ulcerative colitis[6,7,8].

Roche currently faces as many as 5,000 personal injury lawsuits regarding Accutane.  Recently, a jury awarded a $10.5 million verdict after the plaintiff claimed that the drug-maker failed to properly warn them that the medicine would cause inflammatory bowel disease.  A state-court jury in New Jersey found company officials did not properly warn doctors about Accutane’s health risks and awarded three men a total of $12.9 million in damages.


Inflammatory bowel disease, manifested most commonly as Crohn’s disease or ulcerative colitis both involve inflammation in the lining of the digestive track, particularly in the large intestine and rectum.  These afflictions may be disabling, life-threatening, and without cure.  Symptoms include:

  • Abdominal pain
  • Cramping
  • Severe and/or painful diarrhea (In extreme cases, up to 20 movements per day)
  • Blood in bowel movements
  • Vomiting
  • Loss of appetite and weight
  • Intestinal and/or anal abscesses

Other symptoms, unrelated to IBD, which have been associated with the use of Accutane include:

  • Joint pain
  • Arthritis
  • Anemia/fatigue
  • Growth retardation in children
  • Damage to the eyes
  • Liver failure and liver damage
  • Celiac disease
  • Severe depression
  • Suicide

If you or a loved one have taken Accutane and experienced any side effects, please contact Freese & Goss today. Attorneys are available by phone, e-mail, or by clicking here.

[1] Roche Pharmaceuticals.  Roche Discontinues and Plans to Delist Accutane in the U.S.  Press release, June 29, 2009.

[2] FDA.  Isotretinoin (marketed as Accutane) Capsule Information.  October 22, 2010.

[3] DiGiovanna J.  Isotretinoin Effects on Bone.  Journal of the American Academy of Dermatology, 2001, 45(5):S176-82.

[4] O’Reilly K, Shumake J, Gozalez-Lima F, et. al.  Chronic Administration of 13-Cis-Retinoic Acid Increases Depression-Related Behavior in Mice.  Neuropsychopharmacology, 2006, 31:1919-1927.

[5] Sundstrom A, Alfredsson L, Sjolin-Forsberg G, et. al.  Association of Suicide Attempts with Acne and Treatment with Isotretinoin: Retrospective Swedish Cohort Study.  British Medical Journal, 2010;341:c5812.

[6] Reddy D, Siegel C, Kane S.  Possible Association Between Isotretinoin and Inflammatory Bowel Disease.  American Journal of Gastroenterology, 2006, 101(7):1569-73.

[7] Reniers D, Howard J.  Isotretinoin-induced Inflammatory Bowel Disease in an Adolescent.  Annals of pharmacotherapy, 2001, 35(10): 1214-16.

[8] Crockett S, Porter C, Martin C, et. al.  Isotretinoin Use and the Risk of Inflammatory Bowel Disease:
A Case-Control Study.  American Journal of Gastroenterology, 2010, 105:1986-1993.


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