France has reverse-switched medicines containing the cough suppressant dextromethorphan from non-prescription to prescription status with immediate effect. A decree signed on 12 July 2017 by Agnès Buzyn – France's new minister of solidarity and health – also restricts medicines containing the analgesic and cough remedy codeine to prescription status.
The Ministry of Solidarity and Health said it had identified numerous cases of abuse and misuse of these medicines, particularly by adolescents and young adults. The restrictions would bring an end to addictive practices that were "dangerous and potentially fatal", the ministry maintained.
Industry is deeply concerned about the reverse-switches. The Association of the European Self-Medication Industry (AESGP) pointed out there were "few effective substances available non-prescription for the treatment of coughs".
The industry association warned that moving these substances to prescription status would "force citizens to use other treatments, which are either less effective or more problematic from a safety perspective".
More difficult to avoid antibiotics
The AESGP told OTCToolbox the decision was "particularly surprising in light of the intensive debate on antimicrobial resistance in Europe and worldwide, and the strong wish of everybody to avoid the use of antibiotics wherever possible". Taking away well-established treatment options, insisted the AESGP, would make it more difficult to avoid antibiotics.
Dextromethorphan has non-prescription status in most countries around the world, but codeine is only available without a prescription in some countries.
France's decision to reverse-switch codeine comes soon after Australia's Therapeutic Goods Administration (TGA) announced that codeine would be reverse-switched with effect from 1 February 2018 (click here to read the News story).
The TGA said that – following "significant consideration and consultation" – there was "compelling evidence of the harm caused by overuse and abuse of OTC codeine-containing medicines". The regulatory agency added that the US, most of Europe, Hong Kong, Japan, United Arab Emirates and several other countries had already stopped the sale of codeine-containing medicines without a prescription.
Meanwhile, New Zealand is reconsidering the classification of non-prescription medicines containing codeine (click here to read the News story).
Affects four opium derivatives
Buzyn's decree restricts medicines containing four opium derivatives – codeine, dextromethorphan, ethylmorphine and noscapine – to prescription status.
France's Ministry of Solidarity and Health highlighted the growing abuse of Purple Drank – a cocktail based on codeine, an antihistamine and a soda drink – that it said had caused the deaths of two teenagers since the start of 2017.
The ministry pointed out that on 29 June 2017 the French medicines agency, the ANSM, had recommended prescription status for codeine, dextromethorphan, ethylmorphine and noscapine.
Hits many leading OTC companies
The move affects many of France's leading OTC companies including Bouchara-Recordati, Cooper, Ipsen, Mayoly-Spindler, Merck, Pierre-Fabre, Procter & Gamble, Urgo and Zambon.
Non-prescription brands affected by the reverse-switches include Atuxane from Merck, Clarix from Cooper, Drill from Pierre-Fabre, Ergix from Merck, Euphon from Mayoly-Spindler, Fluimucil from Zambon, Humex from Urgo, Neo-Codion from Bouchara-Recordati, Polery from Pierre-Fabre, Prontalgine from Ipsen and Vicks from Procter & Gamble.
Buzyn was appointed minister of solidarity and health in May 2017 following the election of Emmanuel Macron as president and Édouard Philippe as prime minister.
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