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An analysis of legal warnings after drug approval in Thailand.
Regul Toxicol Pharmacol. 2015 Feb; 71(1):108-13.RT

Abstract

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.

Authors+Show Affiliations

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

Pub Type(s)

Journal Article
Research Support, Non-U.S. Gov't
Review

Language

eng

PubMed ID

25445000

Citation

Sriphiromya, Pakawadee, and Anuchai Theeraroungchaisri. "An Analysis of Legal Warnings After Drug Approval in Thailand." Regulatory Toxicology and Pharmacology : RTP, vol. 71, no. 1, 2015, pp. 108-13.
Sriphiromya P, Theeraroungchaisri A. An analysis of legal warnings after drug approval in Thailand. Regul Toxicol Pharmacol. 2015;71(1):108-13.
Sriphiromya, P., & Theeraroungchaisri, A. (2015). An analysis of legal warnings after drug approval in Thailand. Regulatory Toxicology and Pharmacology : RTP, 71(1), 108-13. https://doi.org/10.1016/j.yrtph.2014.10.013
Sriphiromya P, Theeraroungchaisri A. An Analysis of Legal Warnings After Drug Approval in Thailand. Regul Toxicol Pharmacol. 2015;71(1):108-13. PubMed PMID: 25445000.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - An analysis of legal warnings after drug approval in Thailand. AU - Sriphiromya,Pakawadee, AU - Theeraroungchaisri,Anuchai, Y1 - 2014/10/27/ PY - 2014/08/31/received PY - 2014/10/17/revised PY - 2014/10/21/accepted PY - 2014/12/3/entrez PY - 2014/12/3/pubmed PY - 2015/9/4/medline KW - Adverse drug reactions KW - Drug risk management KW - Drug safety KW - Legal warnings KW - Pharmacovigilance SP - 108 EP - 13 JF - Regulatory toxicology and pharmacology : RTP JO - Regul. Toxicol. Pharmacol. VL - 71 IS - 1 N2 - 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. SN - 1096-0295 UR - https://www.unboundmedicine.com/medline/citation/25445000/An_analysis_of_legal_warnings_after_drug_approval_in_Thailand_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0273-2300(14)00253-0 DB - PRIME DP - Unbound Medicine ER -