Ban on Loperamide Liquid for Children

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DOH ADMINISTRATIVE ORDER NO. 5: Ban on Loperamide Liquid for Children

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Title Supreme Court: Ban on Loperamide Liquid for Children

Law: Doh Administrative Order No. 5

Decision Date: Nov 11, 1992

Loperamide hydrochloride liquid preparations for children are banned due to their potential adverse effects on the central nervous system and the lack of established safety and efficacy in pediatric use, as mandated by the Department of Health.

administrative order

drug regulation

consumer protection

A

Reasons for the Ban

Children are more sensitive to the adverse central nervous system (CNS) effects caused by loperamide.
The safety and efficacy of loperamide for children have not been established.
The World Health Organization (WHO) supported this recommendation as seen in their Weekly Epidemiological Record dated December 21-28, 1990.

Regulatory Actions and Enforcement

The National Drug Committee and Bureau of Food and Drugs (BFAD) recommended the ban in the interest of consumer safety.
Loperamide hydrochloride liquid preparations for children shall no longer be registered for market distribution.
The BFAD is mandated to ensure that no loperamide liquid preparations for children are introduced or available in the market moving forward.

Effectivity of the Order

The order takes effect fifteen (15) days after its publication in a newspaper with general circulation.

Legal Authority and Implementation

The administrative order was issued by the Secretary of Health, Juan M. Flavier, M.D., M.P.H., on November 11, 1992.
This order serves to protect consumers, particularly pediatric patients, from potential harm associated with loperamide liquid formulations.

END