2022 Volume 12 Issue 1 Pages 45-53
Thalidomide caused a great drug disaster and was recovered from this world. This incident has greatly advanced regulations and guidelines on drug safety. Dangerous drugs can be predicted in advance. However, thalidomide was approved again in 2008. For the indication of refractory multiple myeloma, strict management by appropriate guidelines is required. As for safety in drug development, the ICH guidelines specify the type and timing of studies. Based on the results of non-clinical safety studies conducted in accordance with the ICH guidelines, clinical trials are conducted, and then appropriate dosage and administration can be determined. The study cannot be conducted in pregnant women or women of childbearing potential except under special circumstances. Most of the descriptions in the package insert are “No experience in pregnant women or women of childbearing potential”. Drugs that are particularly genotoxic are contraindicated. This paper considers the risk of women treated for cancer in the AYA generation based on the revised ICH S5 (R3).
