title: [Risk Management of Teratogenic Drugs ~The Current States of Practice in Europe, US and Japan~].
abstract: Thalidomide was approved for the treatment of multiple myeloma in Japan under a risk management program, named TERMS, in 2008. Since then, we have been conducting a survey of the stakeholders to assess the effectiveness of TERMS. These surveys showed patients had enough knowledge of the risks of thalidomide. In the USA, legislation in 2007 granted its U.S. Food and Drug Administration (FDA) the authority to require Risk Evaluation and Mitigation Strategies (REMS) when necessary to ensure that a drug's benefits outweigh its risks. As of 2015, more than 70 drugs, including thalidomide, have REMS programs. In Germany, in the early 1960s, over 5000 children were born with deformities. Therefore, the safety regulations in Germany go far beyond the European Medicines Agency (EMA) safety regulations at the time of thalidomide re-approval; thalidomide can be prescribed by a special prescribing form, including both proof of the patients' awareness of information about the risks, and participation in a pregnancy prevention program. While Japan has taken similar safety measures, a portion of thalidomide is still privately imported there. By March 2013, 594 patients have been registered to Japan's Safety Management System for Unapproved Drugs (SMUD), which was introduced by the Ministry of Health, Labour and Welfare (MHLW) in 2009. The number of females of child bearing potential (FCBPs) was 33 and the fraction (33/594=5.6%) was higher than that (48/7370=0.7%) in the case of TERMS. Risk management of thalidomide is described in this review.
authors.affiliation: Graduate School of Pharmaceutical Sciences, Osaka University.
authors.forename: Tatsuya
authors.initials: T
authors.lastname: Takagi
authors.forename: Carla
authors.initials: C
authors.lastname: van Bennekom
authors.forename: Steffen
authors.initials: S
authors.lastname: Amann
authors.forename: Chizuko
authors.initials: C
authors.lastname: Hattori
authors.forename: Yuko
authors.initials: Y
authors.lastname: Shirakuni
authors.forename: Tsugumichi
authors.initials: T
authors.lastname: Sato
authors.forename: Masao
authors.initials: M
authors.lastname: Nasu
mesh_terms: D003267:Contraception; D005060:Europe; D005260:Female; D006801:Humans; D007564:Japan; D008297:Male; D011247:Pregnancy; D012308:Risk Management / Q000379:methods / Q000639:trends; D013723:Teratogens; D013792:Thalidomide; D014481:United States
chemical_list: D013723:Teratogens; D013792:Thalidomide