Health
Stronger Accutane safeguards
NEWS IN BRIEF — Posted Dec. 20, 2004
The Food and Drug Administration began strengthening the risk management plan that was already in place for Accutane, or isotretinoin, to try to further reduce the risk of congenital anomalies associated with fetal exposure to the drug.
The System to Manage Accutane Related Teratogenicity, or the SMART program, was one of several similar programs all designed to prevent fetal exposure.
An FDA advisory committee determined last February that the multiple programs could cause confusion and inadvertently allow a patient to take Accutane without being counseled on its dangers. The committee recommended that changes be considered.
The new program, which will go into effect in July 2005, will require registration of not only the physicians who prescribe the drug but also the pharmacies that dispense it and the patients who use it. The program will also require that a negative pregnancy test be obtained from all women who could become pregnant before they take the drug.
A single, centralized registry is to be developed to link prescribers, patients and pharmacies, according to the FDA. Privacy was of critical concern in devising the system, the agency noted.
Note: This item originally appeared at http://www.ama-assn.org/amednews/2004/12/20/hlbf1220.htm.
