Fujimoto Pharmaceutical Corp. has filed an application with the health ministry to manufacture and sell thalidomide as an authorized medicine, more than 40 years after the drug was banned in Japan for causing severe birth defects, according to a company official.
The Health, Labor and Welfare Ministry is expected to make a decision on whether to approve the drug in as little as a year to treat multiple myeloma, a form of bone marrow cancer afflicting about 14,000 people in Japan.
A U.S. company has obtained approval for thalidomide in the country after it was reported the drug is effective in treating the disease.
In Japan, the government gave it “orphan drug” status to provide support in development and fast-track screening as it is intended as a treatment for a rare disease in need of incentives to be commercialized.
The drugmaker pledged it will take precautions to ensure safe use.
“We want to take thorough safety management steps, such as registering the doctors who would administer it and calling on pregnant women not to use it,” Haruo Yamashita, an official of Fujimoto Pharmaceutical, told a news conference at the health ministry Tuesday.
According to Fujimoto, clinical testing has been conducted on 38 patients at 22 institutions who had never used thalidomide.
Two patients became critically ill from suspected side effects, the company said. One developed a perforated stomach one week after thalidomide was discontinued and died two weeks later. It is unknown whether there was a causal link with the agent.
The other had an ischemic heart ailment and recovered after use of thalidomide was terminated.
Patients with multiple myeloma have been calling for the resumption of thalidomide sales in Japan since its effectiveness in treating that form of bone marrow cancer has been recognized in recent years.
Some doctors have been importing the unauthorized drug.
Sale of the drug has been banned in Japan since 1962 because it caused severe birth defects after it was sold in the late 1950s as a sedative and digestive medicine.
Those who have suffered ill effects from thalidomide have been urging that the use of the drug be regulated.
Some 530,000 thalidomide tablets were imported by individuals in 2003, up from about 160,000 in 2001. The ministry said thorough safety measures have not been taken, as some patients were not checked for pregnancy.
Thalidomide was developed in the former West Germany in 1957. Many pregnant women given the drug gave birth to babies with deformities, and more than 300 people in Japan are known to have suffered such birth defects. The number of victims worldwide is said to be in the thousands.
Victims in Japan jointly filed lawsuits starting in 1963. In 1974, the government and manufacturers reached negotiated settlements with the victims.