Ban on Trovafloxacin due to liver risks

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BFAD ADMINISTRATIVE ORDER NO. 1, S. 2000: Ban on Trovafloxacin due to liver risks

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Title Supreme Court: Ban on Trovafloxacin due to liver risks

Law: Bfad Administrative Order No. 1, S. 2000

Decision Date: Jan 3, 2000

Trovafloxacin (Trovan) is banned and recalled from the market due to serious and unpredictable hepatic risks, including potential liver failure and death, following recommendations from the National Drug Committee and the World Health Organization.

administrative order

drug regulation

A

Basis for Regulatory Action and Authority

The Department of Health's National Drug Committee reviewed the safety data concerning Trovafloxacin.
Upon their recommendation and the WHO advisory, regulatory action was deemed necessary to safeguard public health.

Regulatory Provisions and Directives

All drug products containing Trovafloxacin are prohibited from being registered.
Any existing registrations of Trovafloxacin (Trovan) products are revoked and cancelled.
Immediate recall and withdrawal of all stocks of Trovafloxacin are mandated across all drug distribution channels.

Consumer Safety and Public Health Protection

The regulatory action is oriented towards ensuring the safety and protection of consumers from unpredictable and potentially fatal drug-related liver injuries.

Implementation and Authority

The order was adopted and promulgated by the Secretary of Health, Alberto G. Romualdez, Jr., M.D., on January 3, 2000.
It enforces mandatory compliance by all stakeholders involved in drug distribution and marketing within the Philippines.

END