Sildenafil for “blue babies”

BMJ 2002; 325 doi: https://doi.org/10.1136/bmj.325.7373.1174/a (Published 16 November 2002) Cite this as: BMJ 2002;325:1174

Such unlicensed drug use might be justified as last resort

  1. James Oliver, lecturer in clinical pharmacology (James.Oliver@ed.ac.uk),
  2. David J Webb, professor in clinical pharmacology
  1. Clinical Pharmacology Unit and Research Centre, University of Edinburgh, Western General Hospital, Edinburgh EH4 2XU
  2. Department of Neonatal Pediatrics, King Edward Memorial Hospital for Women, Bagot Road, Subiaco, Western Australia 6008, Australia

    EDITOR—We were disappointed to hear that a doctor in India has been criticised for treating pulmonary hypertension in three neonates (so called blue babies) with the phosphodiesterase type 5 inhibitor sildenafil (Viagra), a drug not licensed for this purpose.1

    Many drugs are widely and appropriately used outside their product licence.2 Such prescribing practice is common in adult medicine, but is particularly prevalent in paediatrics because companies rarely undertake the work necessary to gain a licence for children. The decision to prescribe outwith a drug's licence should be supported by evidence of safety and potential benefit and, when possible, by a reasonable body of supporting professional opinion.

    Of course, controlled clinical trials should be performed when possible to evaluate new treatments for specific indications. But these data are not always available, and then clinicians must make difficult decisions …

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