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Related Concept Videos

Pharmacovigilance01:19

Pharmacovigilance

Post-marketing surveillance is a critical component of pharmaceutical regulation, often uncovering unanticipated adverse drug reactions (ADRs) once a drug is widely used over an extended period.
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
Drug Toxicity: Risk factors01:24

Drug Toxicity: Risk factors

Adverse Drug Reactions (ADRs) are potential complications that arise during pharmacotherapy, influenced by multiple risk factors. Age plays a significant role; both neonates and the elderly are at heightened risk due to their respective immature and diminished metabolic and elimination processes. Gender also impacts ADRs, with females experiencing a 1.5 to 1.7-fold greater risk than males, which may be linked to pharmacokinetic, pharmacodynamic, and hormonal differences. Notably, neonates, the...
Therapeutic Drug Monitoring: Affecting Factors01:29

Therapeutic Drug Monitoring: Affecting Factors

Therapeutic Drug Monitoring (TDM) is the clinical practice of measuring specific drug levels in a patient's blood or body tissues to manage and optimize therapy. TDM is crucial for drugs with narrow therapeutic windows, like warfarin and phenytoin, where incorrect doses can lead to treatment failure or severe side effects. This monitoring ensures the dosage administered is within a safe and effective range. The factors affecting therapeutic drug monitoring include:Patient-Specific Factors:a.
Pharmacogenetics of Drug Targets: β₂-Adrenergic Receptors, Apo E, Thymidylate Synthase01:11

Pharmacogenetics of Drug Targets: β₂-Adrenergic Receptors, Apo E, Thymidylate Synthase

Genetic polymorphisms in drug targets have emerged as critical determinants of interindividual variability in drug response and toxicity. Pharmacogenomic investigations increasingly focus on identifying these variations to personalize and optimize therapeutic interventions. A drug target may be a receptor, enzyme, or signaling protein involved in pharmacologic responses or disease-related pathways. While early pharmacogenetic studies focused primarily on drug metabolism, current research...
Drug Toxicity: Overview01:00

Drug Toxicity: Overview

Drug toxicity quantifies the harm a compound causes to an organism, varying by dose and potentially impacting whole systems or specific organs like the liver. Toxic reactions may arise from venomous insect or spider bites, with effects ranging from mild symptoms to severe outcomes such as brain damage or death. Common forms of acute poisoning include ethanol intoxication and overdose of pain or fever medications, with substances like GHB and heroin being particularly lethal at doses close to...
Effect of Hepatic Disease on Pharmacokinetics: Dose Adjustments Due to Hepatic Impairment01:08

Effect of Hepatic Disease on Pharmacokinetics: Dose Adjustments Due to Hepatic Impairment

Hepatic impairment, characterized by decreased liver function, does not uniformly mandate adjustments in drug dosage. Whether dosage modifications are necessary depends on various factors related to the drug's metabolism and elimination pathways. If a drug is primarily excreted via the kidneys and bypasses significant hepatic processing, if it undergoes minimal metabolic transformation in the liver, or if it is volatile and primarily expelled through the lungs, dose adjustments may not be...

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Related Experiment Videos

Risks Associated with 5α-Reductase Inhibitor Use: Analysis of Adverse Drug Reactions Reported to EudraVigilance.

Ricardo Alves1, Samuel Silvestre2, Cristina Monteiro3,4

  • 1Faculty of Health Sciences, University of Beira Interior, 6200-506 Covilhã, Portugal.

Pharmaceuticals (Basel, Switzerland)
|June 26, 2026
PubMed
Summary

Continuous safety monitoring of 5α-reductase inhibitors (5ARIs) like finasteride and dutasteride is vital. Many serious adverse drug reactions (ADRs) reported are not listed in product information, suggesting potential new safety concerns.

Keywords:
5α-reductaseEudraVigilanceadverse drug reactionandrogenic alopeciabenign prostatic hyperplasiadutasteridefinasteridepharmacovigilance

Related Experiment Videos

Area of Science:

  • Pharmacovigilance
  • Drug Safety
  • Androgenetic Alopecia Treatment

Background:

  • 5α-Reductase inhibitors (5ARIs) are widely used for androgenic alopecia and benign prostatic hyperplasia.
  • Despite efficacy, 5ARIs are linked to adverse drug reactions (ADRs), necessitating ongoing safety surveillance.
  • This study investigated ADRs of finasteride and dutasteride, including combination therapies.

Purpose of the Study:

  • To analyze and characterize adverse drug reactions (ADRs) associated with finasteride and dutasteride.
  • To assess the temporal trends, reporter profiles, and affected demographics of reported ADRs.
  • To compare reported ADRs against their respective Summary of Product Characteristics (SmPC).

Main Methods:

  • Retrospective analysis of 7777 ADR reports from EudraVigilance (2005-2023).
  • Examination of temporal evolution, reporter demographics, and patient age groups.
  • Categorization of ADRs by seriousness, outcome, and comparison with SmPC data.

Main Results:

  • The 18-64 years age group reported the most ADRs, with finasteride being most frequently implicated.
  • A majority of ADRs were serious, often persisting without recovery, and many were not listed in the SmPC.
  • The primary seriousness criterion for reported ADRs was 'Clinically important'.

Conclusions:

  • Continuous pharmacovigilance is essential for preventing and mitigating 5ARI-associated ADRs.
  • Unlisted ADRs in the SmPC may represent novel safety signals requiring further investigation.
  • Ensuring population safety and public health necessitates robust drug safety monitoring.