Post-marketing surveillance of levofloxacin 0.5% ophthalmic solution for external ocular infections.
BACKGROUND
Levofloxacin 0.5% ophthalmic solution is an antibacterial formulation, which was approved and marketed for the treatment of ocular infections in Japan in 2000.


OBJECTIVE
This study was designed to investigate the safety and efficacy of levofloxacin 0.5% ophthalmic solution in patients who received treatment for external ocular bacterial infections in regular clinical practice.


METHODS
Patients were recruited from more than 800 medical facilities in Japan, in accordance with Japanese Ministry of Health, Labour and Welfare ordinance guidelines. They were followed during three distinct time periods: April 2000 to December 2001, January 2002 to June 2003, and July 2003 to December 2004.


RESULTS
Information from 6760 patients receiving levofloxacin for the treatment of a variety of ocular infections was collected. Levofloxacin was well tolerated: adverse drug reactions (ADRs) were reported in 42 of 6686 patients (0.63%), with no serious ADRs reported. The most commonly reported ADRs were ocular disorders such as blepharitis, eye irritation, and punctate keratitis. The incidence of ADRs did not differ significantly with age, but it was significantly higher in females (0.82%) than in males (0.36%; p = 0.028). A clinical response was observed in 95.5% of patients receiving levofloxacin, with no difference in response between the three time periods. The rate of response to levofloxacin by bacterial disease ranged from 97.4% in keratitis to 88.3% in dacryocystitis. The rate was lower in patients with dacryocystitis, elderly patients, patients with a long duration of illness, and relapsing cases (all p < 0.001).


CONCLUSIONS
This post-marketing surveillance of levofloxacin, conducted over 4 years, confirms the safety and efficacy of levofloxacin in regular clinical use and highlights that levofloxacin is a promising treatment for a variety of external ocular bacterial infections.
Post-Marketing Surveillance Group, Santen Pharmaceutical Co., Ltd., Osaka, Japan.
Yoshiko
Y
Kanda
Tomoko
T
Kayama
Shinji
S
Okamoto
Masako
M
Hashimoto
Chiemi
C
Ishida
Tomoko
T
Yanai
Mitsuru
M
Fukumoto
Eiichi
E
Kunihiro
D000293:Adolescent; D000328:Adult; D000368:Aged; D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000009:adverse effects*; D002648:Child; D002675:Child, Preschool; D064420:Drug-Related Side Effects and Adverse Reactions; D015817:Eye Infections / Q000188:drug therapy*; D015818:Eye Infections, Bacterial / Q000188:drug therapy*; D005260:Female; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D007564:Japan; D064704:Levofloxacin; D008297:Male; D008875:Middle Aged; D015242:Ofloxacin / Q000008:administration & dosage / Q000009:adverse effects*; D009883:Ophthalmic Solutions / Q000008:administration & dosage / Q000009:adverse effects; D011358:Product Surveillance, Postmarketing; D016896:Treatment Outcome; D055815:Young Adult
D000900:Anti-Bacterial Agents; D009883:Ophthalmic Solutions; D064704:Levofloxacin; D015242:Ofloxacin