22 MARKET NEWS

Japanese PMS indicates fosfomydn safety

In a 6-year postmarketing survey of 35481 cases of fosfomycin usage in Japan, adverse effects occurred in 3.35% of patients who the took the antibiotic as capsules (n = 28 238) and in 2.44% of patients who took a dry syrup formulation (7243). 'Tllese wdues tin definite', Io .. er I,",,. lhose seell up to Illelilfle 0/ approval (4.75'" .. illI capsules, 11.75'" .. illI dry s,rup)', conclude the Japanese researchers.

GI disturbances, especially diarrhoea, were the most common events, accounting for 2.9 and 2.1 % of cases associated with the capsule and dry syrup formulations, respectively. Other common events included liver and bile duct disorders and skin and soft-tissue damage. 'Se,",us sille e/lects see,. after IIIIITleting but 1101 be/ore .. ere psellllo",e",lmulOus colitis all4 ",elena, olle case eacll.' All other adverse effects occurred at an incidence of < 0.01 % each.

In patients receiving capsules, there was a clear dose-dependence in the incidence of adverse events which was absent in the dry syrup group. There appeared to be an increase in the incidence of adverse effects in patients aged> 16 years. Mayama T. yoltoca M. Shimalani I. Obyqi H. Analysis of oral fOifomycin calcium (Fosmicin) sidc-effccts after marlteting. International Journal of Clinical Pharmacology Therapy and Toxicology 31 : 77-82. Feb 1993

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