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Licensed & Unlicensed Indications

Misoprostol is currently only approved by the Food and Drug Administration (FDA) for the prevention and treatment of gastric ulcers resulting from chronic administration of nonsteroidal anti-inflammatory drugs (NSAIDS).

Misoprostol has been extensively studied in reproductive health, and is widely recommended for the treatment of missed and incomplete miscarriages, the induction of abortion, and cervical preparation before uterine instrumentation, induction of labour and postpartum haemorrhage prophylaxis and treatment.

The use of drugs for off-label indications is legal, common practice, and not considered experimental if based on sound scientific evidence. Drug licensing is not proof of effectiveness and many drugs of proven efficacy are not licensed.

In all cases the evidence must be carefully considered and the benefit: risk ratio assessed before a drug is prescribed for an unlicensed indication.

Patients and their carers should be properly informed if a doctor prescribes a licensed drug for an unlicensed indication.


Drug & Indication

Licensed indication?
BNF
RCOG

1.Oxytocin 10im to prevent PPH

No
Yes
Yes

2.Misoprostol for termination of pregnancy before 24 weeks

No
Yes
Yes

3.Antenatal betamethasone to prevent neonatal respiratory distress syndrome in premature deliveries

No
Yes
Yes
4.Clindamycin to treat haemolytic streptococci in pregnancy
No
No
Yes
5.Oxytocin 5 iv to treat missed miscarriage
Yes
No
No

6.Norethisterone (days 19-26) to treat menorrhagia

Yes
Yes
No