Acne drug limits burdensome, doctors say
Monday, February 13th, 2006A plan to prevent birth defects from a widely used acne drug is placing heavy burdens on doctors, patients and pharmacists and should be halted until flaws can be fixed, doctors said on Friday.
The restrictions on Roche AG?s Accutane or generic versions are so cumbersome and time-consuming they may send patients to the Internet, where medicines may be counterfeit and there are no safeguards to prevent pregnancy, critics said.
Accutane is the only drug approved for severe scarring acne that does not respond to other therapies. The drug can cause serious birth defects or miscarriages, and several attempts have been made since its 1982 approval to prevent pregnancies among women taking the drug.