Improving Patient Education and Reducing Risk

Marcia L. Buck, Pharm.D., FCCP

Pediatr Pharm. 2001;7(7) 

In This Article


Isotretinoin, marketed as Accutane® by Roche Pharmaceuticals, has become a mainstay in the management of severe recalcitrant acne. It is increasingly being prescribed for milder acne cases as well. An estimated 500,000 new patients are treated each year.[1] While the efficacy of isotretinoin has been clearly demonstrated, the benefits of therapy must be weighed against the potential for significant adverse events. In the last year, changes in the product labeling and new informed consent documents have been created in an effort to better educate patients about the risks associated with isotretinoin use. This issue of Pediatric Pharmacotherapy will review the data available on isotretinoin adverse events and discuss recent actions by the manufacturer and the Food and Drug Administration (FDA) to reduce risk.