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TORONTO - A multicentre Canadian clinical trial of mifepristone, or "the abortion pill," has been suspended following the death of a study participant.
The New York-based Population Council, which sponsored the study, released a statement Sept. 10 that announced the fatality and said enrolment for the trial would be stopped while the death was investigated.
The Population Council said initial reports suggested the death was caused by septic shock relating to a rare clostridium infection.
"We really believe the death was not caused by the drug," council spokeswoman Christina Horzepa told the Medical Post. "However, we have suspended enrolment in the trial while we investigate."
After years of false starts, the controversial drug, also known as RU-486, was approved for use in medical abortions by the U.S. Food and Drug Administration (FDA) last fall. It is not yet approved in Canada.
Health Canada spokeswoman Roslyn Tremblay said the agency was investigating the circumstances of the woman's death. "This will be done as expediently as possible," said Tremblay.
The FDA also has launched an investigation, which they said could take weeks...