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E-Drug : Nimesulide
1, There IS a FDA bulletin - both hardcopy and on the Internet. For
the information you want there is also the Medical Letter on Drugs
and Therapeutics, which is independent and up-to-date.
2. Nimesulide is NOT mentioned in the last edition of the PDR, not in
the BNF, and not on the EMEA site.
3. It seems to be potentially hepatotoxic, and that is probably the
main reason why registration is being held up.
4. Almost all published information (Medline) on nimesulide is
potentially biased and sponsored by the manufacturer (Review
article and symposium supplement to "Drugs" 1993-1994).
5. Some trials have been done in children in India and in
mediterranean countries. Results are comparable to those obtained
with other OTC NSAIDs like ibuprofen and naproxen - i.e. no clear
need in paediatrics.
Conclusion: No need to hurry - take expectant attitude.
Dr.L.Offerhaus
Koedijklaan 1a, NL-1406KW Bussum, The Netherlands
Phone: +31-35-6923288. Fax: +31-35-6923290
E-mail: LO@EURONET.NL CompuServe: 71530,15
Eur J Clin Pharmacol ONLY:
POB 75552, NL-1070AN Amsterdam, The Netherlands
[Moderators Comment: I think this posting would be a good one to end this
stream. Remember E-DRUG is primarily for Essential Drugs policy and
programming issues and INDICES is for drug information related topics.
Richard Laing Co-Moderator]
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