China's drug watchdog said Wednesday it is continuing its probe
into methotrexate, a drug routinely prescribed to treat acute
leukemia and rheumatoid arthritis, but had eliminated production
errors as a cause of the problems.
The drug, made by Shanghai Hualian Pharmaceutical Co., was
suspended from sale and use after adverse reactions were reported
on July 6 in several leukemia child patients in three hospitals in
Guangxi Zhuang Autonomous Region and Shanghai, according to the
State Food and Drug Administration (SFDA).
SFDA Deputy Director Wu Zhen said "the team sent to reevaluate
the drug has uncovered no problems with the raw materials used to
make the drug or any violations of production procedures."
He added that investigators were shifting their attention to
transportation, storage and administration of the drug.
Wu said possible adverse reactions to methotrexate are clearly
stated in the drug information.
"However, it is abnormal for so many patients to have adverse
reactions in the same short period of time after being injected
with batches 070403A and 070403B of the drug," he said.
"We'll keep the public informed about the state of our
investigations," he promised.
Some children felt pain in their legs and some experienced
difficulty walking after being injected with the drug.
According to WHO statistics, there have been 12,502 reports of
adverse reactions to methotrexate worldwide, including a handful of
very serious cases.
(Xinhua News Agency July 12, 2007)