a-t 2017; 48: 71

FRANCE IS LIMITING PACK SIZES OF DOMPERIDONE (MOTILIUM, GENERICS)

In 2014, the risk of cardiotoxic effects caused by domperidone (MOTILIUM, generics) was evaluated at a European level for the second time and as a result the indication for the prokinetic drug was limited to the treatment of nausea and vomiting and the dose to a maximum of 10 mg per os three times a day for the shortest period of time necessary, generally no more than one week (a-t 2014; 45: 31) (1, 2). Since summer 2016, at the behest of the French drug agency the pack sizes in France have been adjusted accordingly and original packs (OP) containing 30 and 40 tablets of 10 mg of domperidone are gradually being replaced with OPs containing 20 tablets (3, 4). In Germany, in addition to OPs containing 20 tables all providers also sell drugs containing domperidone in pack sizes of 50 and 100 tablets (each containing 10 mg of domperidone). Nothing will change about this in the future: The Federal Institute for Drugs and Medical Devices (BfArM) stated when questioned on this that the decision by the European Commission "did not contain any specifications of pack sizes" and "research on medication errors" in the database of the authority showed four suspected adverse reactions, "none of which involved a pack size problem" (5). Preventative consumer protection looks different to this! -Ed.