Canadian dies during abortion drug test

Published 9:00 pm Tuesday, September 11, 2001

Associated Press

NEW YORK — A Canadian woman died during testing of the abortion pill, and enrollment in the study has been temporarily suspended, the Population Council reported.

The organization, which has the U.S. rights to the pill, mifepristone, said in a statement Monday that the death has been reported to the U.S. Food and Drug Administration and Canadian authorities. The FDA approved the abortion pill for use in the United States a year ago; it has not been approved in Canada.

The Population Council, a nonprofit organization that promotes reproductive research, said initial reports indicated that the cause of death was septic shock resulting from a rare clostridium infection.

The woman’s identity and details of the testing and the death were not released, and it was unclear if the death had any connection to the abortion drug.

"In over a decade’s experience and over 500,000 medical abortions performed with mifepristone and misoprostol in Europe, multiple clinical trials worldwide, and almost one year of product availability in the United States, there has been no previous occurrence of this type," the council’s statement said. "We are deeply saddened by this tragic event, and our thoughts and sympathy are with the woman’s family."

The Canadian study was testing mifepristone, also known as RU-486 or Mifeprex, and a second drug used in tandem, misoprostol. Mifepristone blocks the action of progesterone, vital for an embryo to develop; misoprostol causes contractions to expel the embryo.

The FDA approved mifepristone in September 2000, 12 years after European women began using it and after years of bitter opposition by anti-abortion groups.

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