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Article

21 Nov 2007

Author:
Bellinda Kontominas, Natasha Wallace, Gerard Ryle, Sydney Morning Herald

Watchdog was not told of drug trial [Australia]

Doctors responsible for a drug trial on pregnant women at Wagga Wagga Base Hospital [Australia] may not have obtained the informed consent of all the mothers and went ahead without telling the drug watchdog…Hundreds of women were given the…drug misoprostol to induce labour…, despite warnings by the drug's manufacturer...The family of a…boy born with cerebral palsy has successfully sued the hospital, which has admitted negligence in the drug trial conducted from 2000 to 2003…12 other women are considering legal action against the hospital…[some of them] had not signed consent forms to take part in the trial…[Another] issue was whether they were provided with adequate information about the drug...In…2000 the manufacturer of misoprostol, Searle, since acquired by Pfizer, warned against its use in pregnancy because it could cause…abortion and birth defects…