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Related Concept Videos

Pharmacovigilance01:19

Pharmacovigilance

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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...
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Regenerative Therapy by Suprachoroidal Cell Autograft in Dry Age-related Macular Degeneration: Preliminary In Vivo Report
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RetINal Toxicity And HydroxyChloroquine Therapy (INTACT): protocol for a prospective population-based cohort study.

Narsis Daftarian1,2, Adriana Lima1, Shelby Marozoff1

  • 1Arthritis Research Canada, Vancouver, British Columbia, Canada.

BMJ Open
|February 18, 2022
PubMed
Summary

This study investigates hydroxychloroquine (HCQ) retinal toxicity in systemic lupus erythematosus (SLE) and rheumatoid arthritis (RA) patients. It examines incidence, risk factors, and progression using advanced retinal screening over five years.

Keywords:
epidemiologymedical retinarheumatologytoxicityvetreoretinal

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Toxicity Screens in Human Retinal Organoids for Pharmaceutical Discovery
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Toxicity Screens in Human Retinal Organoids for Pharmaceutical Discovery

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Area of Science:

  • Ophthalmology
  • Rheumatology
  • Pharmacovigilance

Background:

  • Hydroxychloroquine (HCQ) is a crucial medication for systemic lupus erythematosus (SLE) and rheumatoid arthritis (RA).
  • Concerns regarding HCQ-induced retinal toxicity are increasing, necessitating updated risk assessments.
  • Current guidelines recommend revised screening protocols for HCQ users.

Purpose of the Study:

  • To re-evaluate the incidence rate of hydroxychloroquine (HCQ) retinal toxicity.
  • To identify key risk factors associated with HCQ retinopathy.
  • To describe the clinical course and progression of retinal toxicity after HCQ discontinuation.

Main Methods:

  • Prospective, population-based cohort study of 5508 adult SLE and RA patients in British Columbia, Canada, on HCQ for ≥5 years.
  • Annual/biannual retinal screening using spectral domain-optical coherence tomography (SD-OCT) over 5 years, following American Academy of Ophthalmology guidelines.
  • Standardized imaging, diagnosis, and severity staging by masked reviewers; incidence calculated with competing risk of death; hazard ratios for risk factors determined.

Main Results:

  • The study is designed to calculate the incidence of HCQ retinal toxicity.
  • It will identify and quantify risk factors for HCQ retinopathy.
  • The progression of retinal toxicity over a 5-year period will be estimated.

Conclusions:

  • This research will provide updated data on HCQ retinal toxicity incidence and risk factors.
  • Findings will inform clinical practice regarding HCQ monitoring in rheumatic diseases.
  • Understanding the progression of toxicity is crucial for patient management and long-term outcomes.