Clarithromycin is a macrolide antibiotic widely used to treat a number of infections. Several member states have reported major difficulties in procuring clarithromycin-containing products, with paediatric forms (e.g. granules for oral suspension) especially affected.

In line with the approved procedure on technical recommendations on medicine shortage mitigation strategies, the European Drug Shortages Formulary Working Party (EDSForm WP) conducted a bibliographical review, which highlighted the relative scarcity of existing knowledge on extemporaneous or stock oral formulations of clarithromycin that have been or are being used to alleviate the lack of age-appropriate licensed products containing clarithromycin.

The experts of the EDSForm WP have compiled the available information in a technical recommendation intended to help healthcare professionals in their risk-assessment and decision-making processes. It contains technical considerations on the production of unlicensed pharmaceutical preparations containing clarithromycin, as well as three formulations, one of which was shared by the French National Agency for Medicines and Health Products Safety (ANSM). In view of the existing data, additional development of an appropriate formulation for the production of extemporaneous or stock preparations may be necessary.

The EDQM and the EDSForm WP users that, wherever possible, it remains preferable to use a licensed medicine rather than an unlicensed pharmaceutical preparation and that it is the responsibility of the healthcare professionals involved to carry out a risk-benefit analysis for each patient.