Chinese Maker of RU-486 Produced Tainted Leukemia Drug
Reported February 03, 2008
Shanghai Hualian a division of Shanghai Pharmaceutical Group and the sole U. S. supplier of the abortion drug mifepristone is accused of having manufactured contaminated leukemia drugs that have paralyzed or otherwise harmed nearly 200 Chinese cancer patients, the New York Times notes.
The case was presented last week in The Times in an article by Jake Hooker and Walt Bogdanich. Contaminated leukemia drug methotrexate caused leg pain and sometimes paralysis when injected into the spinal area. Cytarabin hydrochloride, anothercancer drug manufactured in the same factory, also began to show side affect.
In September 2007, the Chinese health and drug officials initiated an investigation and found that both drugs had been contaminated during production with vincristine sulfate, another cancer drug, which had been stored in a refrigerator that also stored materials for use in creating other drugs. The factory was closed and two company officials were detained, including the head of the factory.
Danco Laboratories sell the abortion drug mifeprestone, also known as RU-486, to women in the U. S. under the brand name Mifeprex. That pill is made at a different factory that passed an F.D.A. inspection in May 2007 and was inspected three times in recent months by Chinese drug regulators.
Zhou Qun, director of the Chinese FDA’s drug safety control unit, said the agency has inspected the factory that produces mifepristone three times in recent months and found it in compliance. “It is natural to worry,” Zhou said, adding that “these two plants are in two different places and have different quality-assurance people.”
The U.S. FDA released a statement saying the agency is not aware of any evidence to suggest the issue that occurred at the
leukemia drug facility is linked in any way with the facility that manufactures the mifepristone.
On the other hand, Dr. Patrick Johnston, founder of the Association of Pro-life Physicians, told Family News in Focus that
RU-486, even if it is a clean drug, has significant side effects, and some of them have been lethal, with hemorrhaging, incomplete abortion, et cetera.”
According to CitizenLink, RU-486 was fast-tracked through the Food and Drug Administration in 2000, and since then, at least six American women and thirteen women worldwide have died from complications related to the drug.