October 3, 2008
Japan Panel Clears Way for Revival of Thalidomide
Tokyo, Oct. 3 (Jiji Press)--A Japanese Health, Labor and Welfare Ministry panel on Friday approved the production and sale of thalidomide, a controversial sedative-hypnotic banned more than 40 years ago, for the treatment of multiple myeloma, a type of blood cancer, under strict conditions.
The Pharmaceutical Affairs and Food Sanitation Council conveyed the decision to Health, Labor and Welfare Minister Yoichi Masuzoe later in the day. The minister is expected to give his final go- ahead for the drug around mid-October.
Fujimoto Pharmaceutical Corp., based in Matsubara, Osaka Prefecture, western Japan, is expected to start thalidomide sales by the end of this year.
It is very rare for a drug that has caused health problems to go on sale again.
Thalidomide, sold worldwide in the 1950s and 1960s as a sedative- hypnotic, became notorious for causing birth defects when taken by pregnant women. The drug was banned in Japan in 1962.
In the 1990s, however, thalidomide came into spotlight again after studies found that it could be used to treat multiple myeloma. It has been approved in 17 countries overseas.
In August 2006, Fujimoto Pharmaceutical filed for Health Ministry approval for thalidomide production and sales.
While approving the revival of the drug, the Health Ministry panel instructed Fujimoto Pharmaceutical to introduce a registration system for patients as well as doctors and pharmacists to prevent pregnant women from taking the drug.
The panel also called for steps to ensure that thalidomide is prescribed by fully experienced doctors only if patients and their relatives give written consent to the use of the drug.
In addition, the panel demanded that follow-up health examinations be conducted for all patients who take thalidomide.END
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