E-DRUG: Registration of generic misoprostol (cont)
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This is a purely legal matter. The company faced considerable
problems in South America because of illegal use of misoprostol as an
abortifacient, for which the manufacturer was blamed - probably
unfairly. There are no formal trials with misoprostol for this
indications, and the risks are unknown. Despite it being registered
the manufacturer remains responsible for the risks and the
information provided. If anything untoward happens it would be easy
for victims to sue the company in American courts, and it is
understandable that the manufacturer doesn't like the idea.
Leo Offerhaus MD PhD
Chopinstraat 9 NL-1077 GL Amsterdam The Netherlands
Tel. 0031-20-6762434 Fax 0031-20-6756590
E-mail LO@EURONET.NL, CompuServe 71530,15
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