The National Agency for the Safety of Medicines and Health Products (ANSM) has withdrawn from the over-the-counter sale of five medicines that were previously available in open access in pharmacies. This measure was published in the Official Journal of October 30, 2015.
Medicines for nausea and motion sickness
The five drugs concerned are treatments against travel sickness (Mercalm capsule), against nausea (Nausicalm syrup and Nausicalm capsule), against tired (Dynamisan powder for oral solution) and against sore throat (Doli Sore throat Hexamidine / tetracaine, oral spray solution). What they have in common: they all have among their components dimenhydrinate and diphenhydramine. These two substances are effective antihistamines against nausea and vomiting, but “which are characterized by a strong sedative effect at the usual doses” according to Vidal.
Medicines diverted from their uses
ANSM had opened a addictovigilance survey on abuse and dependence linked to these drugs following the notification of several cases of abuse to the network of Centers for Assessment and Information on Drug Dependence (CEIP) in July 2014. The results of this study showed no only the existence of a risk of dependence linked to these molecules, but also that of excessive consumption and frequent misuse of these drugs. However, misuse or overconsumption of these compounds is not without risk: dependence syndrome, memory disorders, hallucinations, tremors, agitation, tachycardia or even chest pain are among the risks associated with an overdose of dimenhydrinate or diphenhydramine.
In addition, the ANSM had recorded ten serious cases including one death linked to overuse of Mercalm during its investigation. In addition, between 2003 and 2014, four cases of chemical submission to these molecules in the context of sexual assault were reported, including 2 in 2014.
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