fosfomycin and Drug-Hypersensitivity

Topics: Adrenal Cortex Hormones; Adult; Anaphylaxis; Angioedema; Basophil Degranulation Test; Drug Hypersensitivity; Erythema; Female; Fosfomycin; Histamine Antagonists; Humans; Hypersensitivity, Immediate; Immunization; Skin Tests; Urinary Tract Infections

Topics: Anaphylaxis; Anti-Bacterial Agents; Drug Hypersensitivity; Female; Fosfomycin; Humans; Immunoglobulin E; Middle Aged; Skin Tests; Urinary Tract Infections

For about 6 years after the marketing of oral formulations of fosfomycin calcium (FOM-Ca) in December, 1980, we collected the data on 35,481 cases and analyzed it regarding safety. Primary side-effects consisted mainly in gastrointestinal disturbances, damage to skin and adnexa, liver and bile duct disorders. Specifically, diarrhea, nausea, abdominal pain, anorexia, eruption and increased serum transaminase were frequent. Serious and newly detected side-effects after marketing were pseudomembranous colitis and melena, one case each. As for the oral administration of FOM-Ca to 83 patients hypertensive to beta-lactams, gastrointestinal side-effects were seen but none of them developed hypersensitivity, an allergic reaction.

Topics: Adolescent; Adult; Aged; Capsules; Child; Child, Preschool; Drug Hypersensitivity; Female; Fosfomycin; Humans; Infant; Infant, Newborn; Japan; Male; Middle Aged; Product Surveillance, Postmarketing; Solutions

An association of pefloxacin plus fosfomycin was used as antibioprophylaxis in beta lactam allergic patients who underwent cardiac surgery with cardiovascular-bypass. Pefloxacin (800 mg), was administered orally, one hour before anesthetic induction and fosfomycin (60 mg/kg) was injected at the time of induction. The whole course of prophylaxis wat 24 hours. Antibiotic concentrations were measured in serum before (P1, P2) during (C1, C2, C3, C4) and after cardiovascular-bypass (P3) and in bone, endocardiac and pleural tissues. The efficacy was evaluated on clinical and biological data. Antibiotic levels of pefloxacin were measured by HPLC and those of fosfomycin by bacteriological method. Antibiotic concentrations are high in blood and tissues, without evidence of cardiovascular-bypass influence. The tissue penetration of both drugs is excellent. Two patients have presented serious post-operative infections. The pharmacokinetic of pefloxacin associated with fosfomycin is appropriate during cardiovascular-bypass and the local antibiotic concentrations are above the MIC of the strains commonly responsible of post operative infections in cardiovascular surgery. The clinical efficacy of this prophylaxis must be studied in a large population of patients.

Topics: Aged; Anti-Bacterial Agents; beta-Lactams; Cardiac Surgical Procedures; Drug Hypersensitivity; Drug Therapy, Combination; Female; Fosfomycin; Humans; Male; Middle Aged; Pefloxacin; Premedication

Twenty-four patients with urinary tract infections were treated with fosfomycin (FOM) to evaluate its effectiveness and safety. They all had shown allergic reactions, mainly to beta-lactams. Lymphocyte stimulation test (LST), leukocyte migration inhibition test (LMT), passive cutaneous anaphylaxis (PCA) and the precipitin reaction were performed to test whether FOM would also cause an allergic reaction. FOM was judged by the physician-in-charge to be effective in all 6 patients (100%) with acute simple cystitis and 8 (72.7%) of 11 patients with chronic complicated urinary tract infections. The drug was also effective in 15 (83.3%) of 18 patients with epididymitis, etc. Regarding the usefulness of FOM, it was judged to be useful in 21 (91.3%) of 23 patients. FOM was very useful in 8 (34.8%) of these 23. In patients tested for LST, the value was lower in cases given FOM than in cases given ampicillin (ABPC), cefazolin (CEZ) or latamoxef (LMOX); there was an especially significant (p less than 0.01) difference with ABPC. All the drugs tested were negative for the LMT, PCA and precipitin reaction tests. No subjective or objective abnormalities were attributed to the FOM treatment, and there were also no abnormal laboratory test values. FOM was evaluated to be an effective and safe antibacterial agent without in vitro or clinical allergic reactions.

Topics: Adolescent; Adult; Aged; Drug Hypersensitivity; Epididymitis; Female; Fosfomycin; Humans; Male; Middle Aged; Prostatitis; Urethritis; Urinary Tract Infections