U.S. RU-486 provider investigated for contaminated leukemia drugs

Beijing, China, Feb 1, 2008 / 04:44 am

A state-owned Chinese pharmaceutical company that manufactures the RU-486 abortion pill faces accusations that tainted leukemia drugs produced by the company have paralyzed or otherwise harmed nearly 200 Chinese cancer patients, the New York Times reports.

The Shanghai Hualian factory that produced the drugs has been closed by drug regulators. In December, China’s Food and Drug Administration said that Shanghai police had begun a criminal investigation, detaining two officials including the head of the factory.

The New York Times reports that last week, a window near the gate of the closed plant displayed a sign from the Chinese FDA accusing the factory of “producing substandard medicine that poses major risks of causing serious harm to human health.”

Shanghai Hualian is the United States’ sole provider of the abortion pill mifepristone, known as RU-486.  The mifepristone factory is an hour’s drive away from the plant under investigation.

The United States Food and Drug Administration said the RU-486 plant passed an inspection in May.  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.”

The allegedly contaminated batch of the cancer drug methotrexate caused leg pain and sometimes paralysis.  Another cancer drug made in the same factory, cytarabin hydrochloride, also began causing adverse reactions, after which investigators began to suspect contamination. 

Officials closed the factory after finding that both drugs had been contaminated during production with vincristine sulfate, another cancer drug.  The vincristine sulfate had been stored in a refrigerator that also stored materials for use in creating other drugs. 

There have been at least 193 cases of adverse reactions to the company’s cancer drug in all of China.  Apparently about half of those injected with the drug still cannot walk.

Dr. Sidney M. Wolf, a consumer advocate, told the New York Times that American regulators ought to be concerned because of accusations of a corporate cover-up.  “Every one of these plants should be immediately inspected,” he said.

Shanghai Hualian, a division of the very large Shanghai Pharmaceutical Group, has had at least two shipments stopped at the United States border.  One consisted of an unapproved antibiotic, while another was a diuretic that had “false or misleading labeling.”  The major pharmaceutical company Pfizer has declined to buy drug ingredients from the Shanghai Pharmaceutical Group because of concerns about the quality of the group’s production standards.

Chinese officials have stripped Shanghai Hualian of its license to produce anti-tumor drugs, though this action will not affect its RU-486 production.

RU-486 is distributed in the United States by Danco Laboratories. According to the New York Times, the United States FDA has never publicly identified the pill’s manufacturer because of opposition from the pro-life movement.