Title
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.
A

Q&A (DOH ADMINISTRATIVE ORDER NO. 5)

Loperamide hydrochloride liquid preparation for children is banned under DOH Administrative Order No. 5, s. 1992.

The primary reasons are that children are more sensitive to its adverse central nervous system (CNS) effects, and its safety and efficacy in children have not been established.

The National Drug Committee and the Bureau of Food and Drugs (BFAD) recommended the ban.

The Order became effective fifteen (15) days from its publication in a newspaper of general circulation.

The BFAD is tasked to ensure that no loperamide hydrochloride liquid preparation for children is introduced or registered for distribution in the market.

Yes, the ban specifically covers loperamide hydrochloride liquid preparations intended for children.

No, such preparations shall no longer be registered or distributed in the market.

The ban is based on recommendations from the National Drug Committee and BFAD due to safety concerns, supported by a 1990 WHO Weekly Epidemiological Record.

The Order was signed and adopted by Juan M. Flavier, M.D., M.P.H., then Secretary of Health.

The December 21-28, 1990 issue of the Weekly Epidemiological Record from the World Health Organization (WHO) supported the recommendation.


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