Past Issues

Thalidomide, developed in 1957 in West Germany was, a widely used sedative in more than 45 countries.
In Japan, it was launched for both of prescription drugs and OTC drugs.

It was revealed that it caused teratogenicity, e.g. phocomelia and miscellaneous organ failures.
Eventually, wide use of thalidomide all over the world caused suffering, including about 10000 thalidomide babies.
After such a suffering from the harmful effects of the thalidomide, it was withdrawn from the drug market in 1962.

Afterwards, it has become recognized as an effective drug for multiple myeloma.
In Japan thalidomide was used mainly using the importing system of drugs for personal use until it was approved Oct 2008 as the drug for multiple myeloma under the condition that the manufacturer implemented a risk management programme (Thalidomide Education and Risk Management System: TERMS).

We have requested that repeatedly the Ministry of Health, Labour and Welfare (MHLW) establish a mandatory patients registration and safety surveillance system to regulate the off-label use of thalidomide imported for personal use.


Our activities are as follows:

2002-10-17
Submission of a written request entitled “A written urgent request on thalidomide”to MHLW.

2003-1-15
A member of Medwatcher Japan attended the symposium “To consider the issue on thalidomide” held by the Japanese Society of Drug Informastics.

2003-2-16
Co-sponsored the “Thalidomide Symposium” held by the foundation for thalidomide victims “Ishizue“

2004-12-22
Submission of a written request entitled “A written request on importing and use of thalidomide”to MHLW

2008-09-11
Submission of a written opinion entitled ”A written opinion on thalidomide”to MHLW

• Drugs
• Systems