Die Information für Ärzte und Apotheker
Neutral, unabhängig und anzeigenfrei
arznei-telegramm®Die unabhängige Information zur Arzneitherapie.
Bestellen Sie ein Probeabo
vorheriger Artikelnächster Artikel

Translation of a-t 2019; 50: 71


France: warning on medicine packaging about paracetamol overdoses

Since the provisions in place to prevent liver damage caused by overdoses of paracetamol (BEN-U-RON, generics) have been found to be insufficient, the French medicines agency, ANSM, is now requiring emphasised warning messages on medicine packaging. As a result, in future paracetamol products will feature the note "overdose = risk" on the front of the package, in a red box with a warning symbol. For paracetamol-only products, a note is also added stating that exceeding the dose can damage the liver. For combination products, a warning will say that other medicines containing paracetamol must not be used at the same time. The back of the packaging of paracetamol-only products will feature information, including about the maximum daily dose and the minimum amount of time to wait between doses. Suppliers now have nine months to put the requirements into place.* In an ANSM survey with almost 2,300 participants (primarily the general public), 97% of those surveyed were in favour of a warning about overdoses on paracetamol packaging (1). We believe that non-prescription, combined cold medicines are particularly problematic in terms of accidentally taken overdoses, as they often contain paracetamol without this being immediately apparent to users. If paracetamol-only products are used at the same time to relieve pain or alleviate fevers, total doses that cause liver damage may be reached (a-t 2007; 38: 105 and 2013; 44: 112-3). We find the action taken by the French authority to be sensible and a lead worth following,-Ed.

1ANSM: press release of 9 July 2019; http://www.a-turl.de/?k=ichi
* Here in Germany, suppliers have been given a business-friendly, long transition period of two years to start putting the following relatively nonspecific warning on the packaging of non-prescription painkillers: "… do not use for longer than specified in the package insert" (a-t 2018; 49: 62), -Ed.

©  arznei-telegramm (Berlin/Germany), August, 2019, protected by copyright laws.

Diese Publikation ist urheberrechtlich geschützt. Vervielfältigung sowie Einspeicherung und Verarbeitung in elektronischen Systemen ist nur mit Genehmigung des arznei-telegramm® gestattet.