Scientific Challenges in Postmarketing Surveillance of Ocular Adverse Drug Reactions

Frederick W. Fraunfelder, Frederick (Fritz) Fraunfelder

Research output: Contribution to journalArticle

15 Citations (Scopus)

Abstract

Purpose: To highlight the challenges of postmarketing surveillance for drug-related adverse events in the practice of ophthalmology. Design: A retrospective review of the medical literature and postmarketing surveillance databases. Methods: MEDLINE literature review of sildenafil-associated or amiodarone-associated optic neuropathy and chloramphenicol-associated blood dyscrasias. Results: Sildenafil, amiodarone, and chloramphenicol may all cause adverse ocular events; however, the data are not conclusive. Conclusions: Reports in peer-reviewed medical journals may be proven incorrect over time. For drug-induced adverse ocular events, there is little true science after the drug reaches the marketplace, so the percentage of incorrect conclusions may be high. Clinicians should be wary of reports of adverse ocular effects until data are confirmed by multiple authors over the long-term. Even so, spontaneous reports from postmarketing surveillance databases may be the first and only signal of an adverse ocular event.

Original languageEnglish (US)
JournalAmerican Journal of Ophthalmology
Volume143
Issue number1
DOIs
StatePublished - Jan 2007

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Drug-Related Side Effects and Adverse Reactions
Amiodarone
Chloramphenicol
Postmarketing Product Surveillance
Databases
Optic Nerve Diseases
Ophthalmology
MEDLINE
Pharmaceutical Preparations
Sildenafil Citrate

ASJC Scopus subject areas

  • Ophthalmology

Cite this

Scientific Challenges in Postmarketing Surveillance of Ocular Adverse Drug Reactions. / Fraunfelder, Frederick W.; Fraunfelder, Frederick (Fritz).

In: American Journal of Ophthalmology, Vol. 143, No. 1, 01.2007.

Research output: Contribution to journalArticle

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