Scientific challenges in postmarketing surveillance of ocular adverse drug reactions.
OBJECTIVE
To highlight the challenges of postmarketing surveillance for drug-related adverse events in the practice of ophthalmology.


METHODS
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.
Fraunfelder
Frederick W
FW
Casey Eye Institute, Oregon Health and Science University, 3375 SW Terwilliger Blvd., Portland, OR 97239, USA. eyedrug@ohsu.edu
Fraunfelder
Frederick T
FT
D016907:Adverse Drug Reaction Reporting Systems; D000638:Amiodarone / Q000009:adverse effects*; D002701:Chloramphenicol / Q000009:adverse effects*; D016208:Databases, Factual; D064420:Drug-Related Side Effects and Adverse Reactions; D006801:Humans; D009901:Optic Nerve Diseases / Q000139:chemically induced; D010265:Paraproteinemias / Q000139:chemically induced; D010879:Piperazines / Q000009:adverse effects*; D011358:Product Surveillance, Postmarketing; D011687:Purines; D012189:Retrospective Studies; D000068677:Sildenafil Citrate; D013450:Sulfones
D010879:Piperazines; D011687:Purines; D013450:Sulfones; D002701:Chloramphenicol; D000068677:Sildenafil Citrate; D000638:Amiodarone