Question & AnswerQ&A (DOH ADMINISTRATIVE ORDER NO. 5 s. 1992)
The order bans loperamide hydrochloride liquid preparations for children, citing safety and efficacy concerns.
The National Drug Committee and the Bureau of Food and Drugs (BFAD) recommended the ban.
Children are more sensitive to the adverse central nervous system (CNS) effects of loperamide and its safety and efficacy in children have not been established.
The World Health Organization (WHO), as cited in the Weekly Epidemiological Record dated December 21-28, 1990, supported the recommendation.
Such preparations shall no longer be registered for distribution in the market.
The Bureau of Food and Drugs (BFAD) is responsible for ensuring that such preparations are not introduced into the market.
The order took effect fifteen (15) days after its publication in a newspaper of general circulation.
It specifically bans loperamide hydrochloride liquid preparations intended for use by children.
The purpose is to protect children’s safety and consumers’ health by preventing exposure to potentially harmful effects of the drug.