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.
Is abortion in South Africa illegal, or was the issue the off-label
use of misoprostol?
[Abortion is legal in SA since 1.2.97; the discussion is about
liability and off-label use - moderator]
The off-label use of a drug is common practice. Neither croup nor
BPD is an offical indication for dexamethasone (according to the
FDA), but they are certainly considered clinically appropriate uses
of the drug.
If one restricted the use of a drug to official indications and
patient populations, much of the formulary of a pedicatric
hospital would vanish.
There are no formal trials with misoprostol for this
indications, and the risks are unknown.
This is simply not true. Misoprostol has been studied in
combination with both RU-486 and methotrexate.