4．Evaluation of the Risk Minimization Plan of the Drugs such as Thalidomide

Abstract

If mother use drugs during pregnancy, the risk to the fetus is concerned. So the management of the drug is important. Previously, we have experienced The Thalidomide Disaster, the drug has not been used for many years since then. However, since thalidomide is found to have an effect on multiple myeloma, its management method is problematic. In the patients who use thalidomide, there are few women with the possibility of pregnancy. And by strict management, it has been concerned about the problem of the things that is difficult to use in patients not related to pregnancy. Isotretinoin is currently being used in the United States as the drug for acne therapy. Although there is no adaptation in Japan, the physician personally import the drug and administer to the patients. Because a lot of childbearing women are included in the patient who use the drug, strict management is necessary. Because the drug is not marketed in Japan, the offer of the information is not enough. Valproic acid has both adaptation the prevention of the migraine headache other than epilepsy. The control of epilepsy is very important, there are patients that use the drug after consideration of risk benefit balance. On the other hand, benefit was relatively small when use it for the prevention of the migraine headache. FDA prohibited the use during pregnancy for this purpose. In Japan, it is the same regulation regardless of adaptation, and balance of the risk benefit is not clear. It was thought that different attention awakening should be carried out by adaptation in future.