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Mylis (sodium prasterone sulfate)

Mylis(sodium prasterone sulfate hydrate, DHA-S)is a cervical ripening and labour inducing agent. Intravenous injections(approved in 1980)and vaginal suppositories (approved in 1997)have been used in Japan for over 30 years. Although Mylis facilitates ripening of the uterine cervix, there is no evidence that it will prevent dystocia. However, some adverse reactions to the drug in mother and fetus have been reported.It is also a local drug only available in Japan.

In March 2003, we requested that the Ministry of Health Labour and Welfare, the manufacturers (4 companies), and the Japan Association of Obstetricians and Gynecologists・Japan Society of Obstetrics and Gynecology respectively, re-evaluate, suspend marketing, and study the adverse effects of the drug.

In July 2009, Schering-Plough announced that it will stop selling Mylis in Japan.


  • YAKUGAI Ombudsperson
  • Tie-up Group

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