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The link between sunshine and phototoxicity of sparfloxacin
Author(s) -
Pierfitte Corinne,
Royer René Jean,
Moore Nicholas,
Bégaud Bernard
Publication year - 2000
Publication title -
british journal of clinical pharmacology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.216
H-Index - 146
eISSN - 1365-2125
pISSN - 0306-5251
DOI - 10.1046/j.1365-2125.2000.00212.x
Subject(s) - phototoxicity , pharmacovigilance , sunlight , sparfloxacin , medicine , environmental health , drug , public health , pharmacology , toxicology , chemistry , biology , pathology , biochemistry , physics , ofloxacin , astronomy , ciprofloxacin , in vitro , antibiotics
AimsTo test the association between reporting rates for sparfloxacin‐induced phototoxicity and sunlight u.v. exposure, and the effects of regulatory action.MethodsThe reporting rates for phototoxicity with sparfloxacin to the French Pharmacovigilance System or to the Drug Manufacturer were compared with concurrent national mean u.v. exposure obtained from Météo‐France, before and after the regulatory restrictions and warnings.ResultsThere were 371 severe phototoxic reaction reports during the first 9 months of marketing (reporting rate of 0.4 per thousand treated patients), approximately four to 25 times that reported for other fluoroquinolones. The reporting rate correlated highly ( r = 0.873, P < 0.001) with the mean monthly u.v. exposure from sunlight (from Météo‐France). Regulatory action including warnings for physicians, and restricted indications dramatically decreased the number of reports, but not the reporting rate.ConclusionsThis is the first demonstration of a strong association between sunlight exposure in a population and drug‐induced phototoxicity. Regulatory action had no effect on the reporting rate (individual exposed patient risk), though it solved the public health issue.