Surprises of off-label drug use - where had all the Prostin gone?

Abstract

The off-label use of drugs is common, particularly in paediatrics, where many drugs have yet to undergo the rigorous scrutiny demanded by authorities such as the Medicines Control Council (MCC) and the US Food and Drug Administration (FDA) before registration.1,2 Yet some drugs (e.g. paracetamol, salbutamol) are so commonplace in paediatric practice that it may come as a surprise that their use is indeed off-label in many circumstances. Problems may arise when an important drug in everyday (off-label) use is unexpectedly in short supply. An example is dinoprostone, marketed in South Africa as Prostin E2 by Pfizer South Africa (but curiously not listed on their website). Its registered use in South Africa is for induction of labour (as an oral 0.5 mg tablet), yet it is commonly used in South Africa for the emergency maintenance of ductal patency in newborn babies.