The link between sunshine and phototoxicity of sparfloxacin.
OBJECTIVE
To test the association between reporting rates for sparfloxacin-induced phototoxicity and sunlight u.v. exposure, and the effects of regulatory action.


METHODS
The 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.


RESULTS
There 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.


CONCLUSIONS
This 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.
Pierfitte
C
C
Department of Pharmacology, and Centre de Pharmacovigilance, CHU-Bordeaux, 33076 Bordeaux Cedex, France.
Royer
R J
RJ
Moore
N
N
Bégaud
B
B
D000293:Adolescent; D000328:Adult; D016907:Adverse Drug Reaction Reporting Systems; D000368:Aged; D000369:Aged, 80 and over; D000890:Anti-Infective Agents / Q000009:adverse effects*; D002648:Child; D017484:Dermatitis, Phototoxic / Q000453:epidemiology / Q000209:etiology*; D016021:Epidemiologic Studies; D005260:Female; D024841:Fluoroquinolones; D005602:France / Q000453:epidemiology; D006801:Humans; D008297:Male; D008875:Middle Aged; D013472:Sunlight / Q000009:adverse effects*; D014466:Ultraviolet Rays
D000890:Anti-Infective Agents; D024841:Fluoroquinolones; C061363:sparfloxacin