Accutane®

Accutane is a synthetic variation of Vitamin A, manufactured by La Roche Hoffman, one of the world’s leading pharmaceutical manufacturers. It can be a powerful agent in treatment of severe acne. There are a number of brands of this medication on the market, including Accutane, Sotret, Raccutane, Amnesteem, and many others.

Accutane has been linked to birth defects and a number of other serious side effects. 

Adverse Side Effects

The usage of Accutane® is directly linked to a number of serious gastrointestinal complications including Ulcerative Colitis, Inflammatory Bowel Disease (IBD) and Crohn’s Disease. There has been a high incidence rate of required drastic surgical treatments by patients who use Accutane for treatment. It may involve the removal of part of the rectum or colon. Adverse side effects can take several years to show. 

The FDA lists the possible serious side effects known to be associated with Accutane use as follows: mental problems - sleeping disorders, depression, or suicidal thoughts and attempts; brain problems - severe headaches, seizures or stroke; stomach problems - abdominal pains, inflammatory bowel disorder, rectal bleeding or dark urine; bone and muscle problems; back and joint pain; hearing problems - hearing loss or constant ringing; vision problems - loss of sight, blurred vision or painful dryness; lipid problems - high levels of cholesterol and other fats; allergic reactions - fever, rash or red patches and/or bruises on legs; trouble breathing; convulsions; slurred speech; birth defects - deformities, miscarriage, premature birth or death of the baby

FDA ALERT - Suicidal Alert

In addition to the strengthened risk management program, the FDA continues to assess reports of suicide, or suicide attempts associated with the use of Accutane®. All patients treated with Accutane® should be observed closely for symptoms of depression or suicidal thoughts, such as anger, sad mood, irritability, loss of pleasure or interest in social or sports activities, acting on dangerous impulses, sleeping too much or too little, school or work performance going down, changes in weight or appetite, or trouble concentrating, or for mood disturbance, psychosis, or aggression. Patients should stop Accutane® and you or the caregiver should contact your physician immediately if any of these symptoms are present. 

"Accutane must not be used by female patients who are or may become pregnant. There is an extremely high risk that severe birth defects will result if pregnancy occurs while taking Accutane in any amount, even for short periods of time. 

FDA ALERT - Birth Defect Warning

Potentially any fetus exposed during pregnancy can be affected. There are no accurate means of determining whether an exposed fetus has been affected. Birth defects which have been documented following Accutane exposure include abnormalities of the face, eyes, ears, skull, central nervous system, cardiovascular system, and thymus and parathyroid glands. 

Cases of IQ scores less than 85 with or without other abnormalities have been reported. There is an increased risk of spontaneous abortion, and premature births have been reported."

Accutane® Research & Studies

Prior to the approval of Accutane® studies showed that Accutane® can cause fetal abnormalities in lab animals. Once Accutane® was approved; the FDA warned those using Accutane® of the potential for birth defects. 

According to the New York Times, since 1982 – 25% to 35% of babies born to mothers who took Accutane® during their pregnancy suffered malformations of the heart, head, and face. A much higher percentage developed learning disabilities and other problems that were not apparent at birth. More recently, numerous reports of severe depression and suicide attempts have been linked to Accutane users.

Accutane® was originally manufactured for treatment of severe acne; today most dermatologists will prescribe it for mild acne cases. The side effects of taking this harsh medication outweigh the benefits when taken for mild cases of acne.

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Cases likely to be referred.