Regulatory discrepancies and patient-safety risks from the continued marketing of withdrawn medicines in Ecuador, Colombia, and Peru (2014-2025) - PubMed
4 hours ago
- #pharmacovigilance
- #patient safety
- #regulatory alignment
- Study evaluates regulatory discrepancies in Ecuador, Colombia, and Peru regarding withdrawn medicines (2014-2025).
- 53 APIs were withdrawn globally, mostly for safety concerns (69.81%), followed by lack of efficacy (22.64%) and manufacturer decisions (7.55%).
- Ecuador retained 16.98% of withdrawn APIs, Peru and Colombia each retained 7.55%.
- Persisting products include modified-release paracetamol, hydroxyethyl starch, and ulipristal 5 mg, linked to serious adverse events.
- Regulatory databases often lack public withdrawal notices, highlighting transparency and pharmacovigilance weaknesses.
- Urgent need for regional harmonization and public disclosure of regulatory actions to enhance patient safety.