Reports of hallucinations after use of oral antihistamine promethazine prompts Dutch Medicines Evaluation Board to order warning on summary of product characteristics.
Netherlands’ Medicines Evaluations Board has ordered marketing authorization holders of promethazine-containing drugs to add to product packaging a warning about hallucinations as a possible side effect of use.
The regulator said it was acting after the national pharmacovigilance center, Bijwerkingencentrum Lareb, received 11 reports of hallucinations associated with...
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