Tightening the control on Accutane

Filed in archive Treatment on August 12, 2005

The FDA is requiring even tighter restrictions for the acne drug, Accutane. birth defects are the major side effect:

Patients and doctors must register with manufacturers before using or prescribing Roche Holding AG's acne drug Accutane or its generic versions, U.S. regulators said on Friday.

The requirement is part of a plan to strengthen safeguards meant to keep pregnant women from taking Accutane, the Food and Drug Administration said in a statement. The drug can cause birth defects.

The FDA also said it approved changes to existing warnings "so that patients and prescribers can better identify and manage the risks of psychiatric symptoms and depression" before and after prescribing Accutane.

("US FDA unveils tighter restrictions on acne drug", Reuters/ABC News, Aug.12)