{"title":"Regulatory discrepancies and patient-safety risks from the continued marketing of withdrawn medicines in Ecuador, Colombia, and Peru (2014-2025).","authors":"Aida Miranda, Camila Lopez, Shabnam Santos, Ariel Moncayo, Fatima Morales, Enrique Teran","doi":"10.1515/dmpt-2025-0081","DOIUrl":null,"url":null,"abstract":"<p><strong>Objectives: </strong>To evaluate whether international decisions to withdraw medicines for safety, efficacy, or commercial reasons were reflected in the regulatory actions of Ecuador, Colombia, and Peru.</p><p><strong>Methods: </strong>A retrospective, descriptive, cross-sectional analysis identified active pharmaceutical ingredients (APIs) withdrawn globally by Stringent Regulatory Authorities (SRAs) between January 1, 2014, and June 30, 2025. Data were obtained from published SRA communications and verified in national regulatory databases - ARCSA (Ecuador), INVIMA (Colombia), and DIGEMID (Peru) - to determine current marketing status. APIs were categorized as <i>never registered</i> (no evidence in current or archival databases), <i>previously registered</i> (formally canceled/suspended with a safe of efficacy rationale), <i>previously registered</i> (authorization expired without an explicit safety rationale), or <i>currently registered</i> (active marketing authorization).</p><p><strong>Results: </strong>Fifty-three APIs were withdrawn internationally, predominantly for safety concerns (69.81 %), followed by lack of efficacy (22.64 %) and manufacturer decisions (7.55 %). The European Medicines Agency issued most withdrawals, particularly for oncologic and hormonal agents. Despite these actions, Ecuador retained 16.98 % of withdrawn APIs on its market, Peru 7.55 %, and Colombia 7.55 %. Persisting products included modified-release paracetamol, hydroxyethyl starch, and ulipristal 5 mg - drugs associated with hepatotoxicity or fatal adverse events. Regulatory databases often list expired or active authorizations without public withdrawal notices.</p><p><strong>Conclusions: </strong>Substantial misalignment persists between international and Andean regulatory decisions. The continued regulatory authorization of withdrawn medicines highlights weaknesses in pharmacovigilance and transparency, underscoring the urgent need for regional harmonization and public disclosure of regulatory actions.</p>","PeriodicalId":11332,"journal":{"name":"Drug metabolism and personalized therapy","volume":" ","pages":""},"PeriodicalIF":0.0000,"publicationDate":"2026-03-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Drug metabolism and personalized therapy","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1515/dmpt-2025-0081","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"Pharmacology, Toxicology and Pharmaceutics","Score":null,"Total":0}
引用次数: 0
Abstract
Objectives: To evaluate whether international decisions to withdraw medicines for safety, efficacy, or commercial reasons were reflected in the regulatory actions of Ecuador, Colombia, and Peru.
Methods: A retrospective, descriptive, cross-sectional analysis identified active pharmaceutical ingredients (APIs) withdrawn globally by Stringent Regulatory Authorities (SRAs) between January 1, 2014, and June 30, 2025. Data were obtained from published SRA communications and verified in national regulatory databases - ARCSA (Ecuador), INVIMA (Colombia), and DIGEMID (Peru) - to determine current marketing status. APIs were categorized as never registered (no evidence in current or archival databases), previously registered (formally canceled/suspended with a safe of efficacy rationale), previously registered (authorization expired without an explicit safety rationale), or currently registered (active marketing authorization).
Results: Fifty-three APIs were withdrawn internationally, predominantly for safety concerns (69.81 %), followed by lack of efficacy (22.64 %) and manufacturer decisions (7.55 %). The European Medicines Agency issued most withdrawals, particularly for oncologic and hormonal agents. Despite these actions, Ecuador retained 16.98 % of withdrawn APIs on its market, Peru 7.55 %, and Colombia 7.55 %. Persisting products included modified-release paracetamol, hydroxyethyl starch, and ulipristal 5 mg - drugs associated with hepatotoxicity or fatal adverse events. Regulatory databases often list expired or active authorizations without public withdrawal notices.
Conclusions: Substantial misalignment persists between international and Andean regulatory decisions. The continued regulatory authorization of withdrawn medicines highlights weaknesses in pharmacovigilance and transparency, underscoring the urgent need for regional harmonization and public disclosure of regulatory actions.
期刊介绍：
Drug Metabolism and Personalized Therapy (DMPT) is a peer-reviewed journal, and is abstracted/indexed in relevant major Abstracting Services. It provides up-to-date research articles, reviews and opinion papers in the wide field of drug metabolism research, covering established, new and potential drugs, environmentally toxic chemicals, the mechanisms by which drugs may interact with each other and with biological systems, and the pharmacological and toxicological consequences of these interactions and drug metabolism and excretion. Topics: drug metabolizing enzymes, pharmacogenetics and pharmacogenomics, biochemical pharmacology, molecular pathology, clinical pharmacology, pharmacokinetics and drug-drug interactions, immunopharmacology, neuropsychopharmacology.
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