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Regul Toxicol Pharmacol. 2015 Feb;71(1):108-13. doi: 10.1016/j.yrtph.2014.10.013. Epub 2014 Oct 27.

An analysis of legal warnings after drug approval in Thailand.

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Health Product Vigilance Center, Food and Drug Administration, Ministry of Public Health, Thailand; Chulalongkorn University, Phayathai Road, Bangkok, Thailand. Electronic address:
Chulalongkorn University, Phayathai Road, Bangkok, Thailand.


Drug risk management has many tools for minimizing risk and black-boxed warnings (BBWs) are one of those tools. Some serious adverse drug reactions (ADRs) emerge only after a drug is marketed and used in a larger population. In Thailand, additional legal warnings after drug approval, in the form of black-boxed warnings, may be applied. Review of their characteristics can assist in the development of effective risk mitigation. This study was a cross sectional review of all legal warnings imposed in Thailand after drug approval (2003-2012). Any boxed warnings for biological products and revised warnings which were not related to safety were excluded. Nine legal warnings were evaluated. Seven related to drugs classes and two to individual drugs. The warnings involved four main types of predictable ADRs: drug-disease interactions, side effects, overdose and drug-drug interactions. The average time from first ADRs reported to legal warnings implementation was 12 years. The triggers were from both safety signals in Thailand and regulatory measures in other countries outside Thailand.


Adverse drug reactions; Drug risk management; Drug safety; Legal warnings; Pharmacovigilance

[Indexed for MEDLINE]

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