Two drugs for nausea and motion sickness were placed under restriction after reports of abuse and misuse.
Two drugs distributed over the counter in pharmacies will be subject to restriction due to abuse and misuse, announces the ANSM in a information point. Dimenhydrinate (Mercalm and Nausicalm), antihistamines indicated in “the prevention and treatment of motion sickness”, and transient nausea, will now only be available with a prescription.
This decision follows the notification of several cases of abuse and misuse by the agency’s addictovigilance network, particularly among adolescents. Diphenhydramine (Nautamine) is also covered by this notification, but the delivery of this specialty is already subject to prescription.
10 “serious” cases
In July 2014, the Poitiers CEIP (Center for Evaluation and Information on Pharmacodependence) was tasked with conducting a survey on the use of diphenhydramine and dimenhydrinate.
The data does seem to justify some vigilance. Over the period 2003-2014, 59 notifications were observed within the CEIP network. “It is possible or probable overconsumption (25 cases), abuse (21 cases), dependence (11 cases), misuse (4 cases) and a withdrawal syndrome (1 case)”, specifies the ANSM Commission on Narcotic Drugs and Psychotropics in its report session.
Ten serious cases have been reported, including one death of “an unknown cause of a man abusing Mercalm”. In addition, four cases of “chemical submission in a context of sexual assault were reported, including two in 2014”, explains the Commission, recalling cases of abuse and dependence observed in Europe and the United States.
Given this risk of abuse and diversion, the ANSM asks healthcare professionals to be particularly vigilant when prescribing and dispensing these drugs.
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