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The French Agency for Safety and Health Products (AFSSAPS) “has reconsidered the risk / benefit of this drug and voted against his inclusion in the market” says a spokesperson.
Noctran ® (chlorazépate dipotassique, acépromazine, acéprométazine) has been used in the treatment of sleeping disorders in France since 1988. The drug has been associated with voluntary overdoses and adverse effects such as neurological and psychiatric disorders, and can also cause falls.
Pharmacists and doctors are asked to inform patients of the market withdrawal on October 27th 2011, and discuss suitable alternatives. Patients should not stop suddenly stop taking their medication, but should instead consult their doctor. Menarini, the current holders of the marketing authorisation of Noctran, will soon release further information.