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.