May 12, 2010

Accutane (generic isotretinoin) is a prescription drug used as a therapy to treat nodular acne when other medications have not worked, including antibiotics.  However, given the serious side effects associated with Accutane use, Accutane should only be used on severe acne that is scar forming.  Accutane has been associated with birth defects, decreased night vision, kidney damage, high triglycerides, musculoskeletal problems, and more recently, psychiatric disorders.  As to psychiatric disorders, the drug bears the following Accutane warning:  “Accutane may cause depression, psychosis, and rarely, suicidal ideation, suicide attempts, suicide, and aggressive and/or violent behaviors.  Discontinuation of Accutane therapy may be insufficient, further evaluation may be necessary.  No mechanism of action has been established for these events.”   The FDA established these warnings after receiving many reports from consumers.   Early on, the FDA warned Roche, the manufacturer of Accutane, that its promotional materials contained false and misleading information.  In particular, the FDA took issue with Roche’s claims that Accutane was an effective treatment for “psychosocial trauma” that is associated with nodular acne.  One of the more disturbing reports involved a 15-year-old boy who flew a small plane into a building in Tampa, Fl. while he was taking Accutane.  In order to prevent these types of incidents, the FDA placed information on its website to inform consumers how to recognize psychiatric problems in adolescents and young adults who may be taking Accutane.

Discuss Any Accutane Side Effect With Your Healthcare Provider:

It is important that you talk with your healthcare provider before taking Accutane.  Let your doctor know if you have a history of depression or any other related mental illness.  It is also important for the doctor to know if you have high triglycerides, liver dysfunction of any kind, osteoporosis, allergies, or if you are pregnant, thinking of becoming pregnant, or are breast-feeding.

As Accutane can cause severe birth defects if taken while pregnant, it is essential that you do not take Accutane while you are pregnant, and you should not get pregnant while taking the drug or for one month after you stop Accutane therapy.  There are strict rules for taking Accutane, especially for women of childbearing age.  Women of childbearing age must use  two reliable forms of birth control and must have a negative pregnancy test done every month.  Each prescription has to be authorized using the iPledge system before your prescription can be filled and you must buy your prescription within 7 days of authorization.

If you or any of your family members have a history of depression, psychosis, or suicidal behavior make sure your healthcare provider knows.  It is important for you and your family members to watch for any mood swings or mental changes that could indicate psychiatric Accutane side effects.  Some behavioral changes include a sad mood, hopelessness, feelings of guilt or worthlessness, loss of pleasure, difficulty concentrating, hallucinations or delusions, or changes in sleep patterns.  You need to report these behavioral changes to your doctor immediately.

If you have experienced depression, suicidal thoughts, or any other Accutane side effect you may be entitled to financial compensation. Accutane Lawsuits are currently being filed across the country.


Susan Ardizzoni, Ph.D. holds a Doctorate in Biology with a major in Neuroscience (medical) and minors in Biochemistry, Physics, and Mathematics with experience in basic and clinical research.  Although the author is not an attorney, this article was sponsored by the law firm of Bernstein Liebhard LLP and constitutes Attorney Advertising.  To learn more about Accutane side effect or Accutane warning please visit

Published November 17, 2011 by