Health: Japan OKs thalidomide to treat blood cancer

| McClatchy Newspapers

10/4/2008 -

TOKYO — A health ministry subpanel on pharmaceutical affairs approved Friday the production and sale of thalidomide, a sedative hypnotic banned in 1962 after its use caused severe birth defects, as a drug for a type of blood cancer, ministry officials said.

With the approval, the Health, Labor and Welfare Ministry will give the green light for marketing the drug to Fujimoto Pharmaceutical Corp. in the middle of this month at the earliest to allow the Matsubara, Osaka Prefecture-based company to start domestic sales of thalidomide within the year, 46 years after it was banned in 1962 because of birth defects that caused severe deformities to arms and legs, they said.

It is rare for a drug proven to have caused defects to be permitted to resume.

In its report to the ministry, the pharmaceutical subpanel of the Pharmaceutical Affairs and Food Sanitation Council has issued conditions for allowing the production and sale of thalidomide as follows:

• The parties concerned must strictly observe safety guarantee measures.

• Doctors must inform patients in writing about both the efficacy and dangers of using the drug and obtain their consent before prescribing the drug.

• All the patients' cases should be studied and announced.

Safety measures will oblige the pharmaceutical firm to register patients, doctors and pharmacists, and log information such as the numbers of pills prescribed and recover unused amounts, the officials said.

Thalidomide will only be allowed as a drug for treating multiple myeloma, of which there are about 14,000 patients. Of those patients, only those who do not show improvement using other medications or have the recurrent type of the disease — together about 30 percent of total patients — will be eligible for the drug.

Pregnancy tests will be required for prescriptions to female patients to prevent use of the drug on pregnant women. A third-party organ will be established comprising representatives from the ministry, thalidomide defects' victims and multiple myeloma patients to check whether the procedure is observed.

The drug's benefits on multiple myeloma treatment were reported overseas in the 1990s, and its use already has been approved in 17 countries. Doctors in Japan have prescribed the drug to about 800 patients through imports, but fluctuating prices of imported drugs caused by changing exchange rates and the use of the drug by family members of patients led to both patients and thalidomide victims calling for government approval of domestic sales and strict control over the use of the drug.