Ban on Loperamide Liquid for Children

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DOH ADMINISTRATIVE ORDER NO. 5 s. 1992: Ban on Loperamide Liquid for Children

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Title Source: Supreme Court: Ban on Loperamide Liquid for Children

Law: Doh Administrative Order No. 5 S. 1992

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.

Law Summary

Basis of the Ban

Children are more sensitive to the adverse CNS effects of loperamide.
The safety and efficacy of loperamide for children have not been established.
The ban is supported by international health authorities, including the World Health Organization (WHO) as cited from the Weekly Epidemiological Record dated December 21-28, 1990.

Legal and Regulatory Measures

The National Drug Committee and the Bureau of Food and Drugs recommended this prohibition.
The ban prohibits the registration, distribution, and marketing of loperamide hydrochloride liquid preparations for children.
The Bureau of Food and Drugs (BFAD) is tasked with ensuring that no loperamide liquid preparation for children is introduced into the market.

Effective Date and Enforcement

The order banning loperamide hydrochloride liquid preparation for children becomes effective fifteen (15) days after publication in a newspaper of general circulation.

Purpose of the Order

The measure is taken in the interest of public safety and consumer protection.

Authority and Adoption

This administrative order was adopted on November 11, 1992.
Signed by the Secretary of Health, Dr. Juan M. Flavier, M.D., M.P.H.

END