Off-Label Use

Licensed & Unlicensed Indications

Misoprostol is currently only approved by the Food and Drug Administration (FDA) in the US for the prevention and treatment of gastric ulcers resulting from chronic administration of non-steroidal anti-inflammatory drugs (NSAIDS). In some other countries dedicated products for several indications in OB/Gyn have been marketed or are expected in the next years.

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 & IndicationLicensed indication?BNFRCOG
1.Oxytocin 10im to prevent PPHNoYesYes
2.Misoprostol for termination of pregnancy before 24 weeksNoYesYes
3.Antenatal betamethasone to prevent neonatal respiratory distress syndrome in premature deliveriesNoYesYes
4.Clindamycin to treat haemolytic streptococci in pregnancyNoNoYes
5.Oxytocin 5 iv to treat missed miscarriageYesNoNo
6.Norethisterone (days 19-26) to treat menorrhagiaYesYesNo