The FDA's limitation of it will severely affect the lives of tens of thousands of teenagers, men and women. Last month, during hearings before the advisory panel on the risks of Accutane, testimony was given regarding the use of the drug during pregnancy and the possible psychological side effects such as depression and suicide.
Depression is a common problem in adolescents with or without acne.
According to testimony presented during the hearing, there are several alternate risk factors that are more likely to be associated with depression and suicide than the use of Accutane. Many acne patients report feeling insecure, inferior, maladjusted, and even depressed, especially those patients with severe cystic acne, which can only be treated by Accutane. Education, not regulation, is the key to safe use of this drug. Another issue raised during the hearing included the precautions needed by women of childbearing age when taking this drug, including discussions on adequate forms of birth control and monthly pregnancy tests. Since isotretinoin may cause birth defects, women in this age group must take the utmost precautions to prevent pregnancy during this therapy.