OBJECTIVE: To review the safety and pharmacokinetics of antimicrobials recommended for anthrax postexposure prophylaxis and treatment in pregnant women. DATA SOURCES: Articles were identified in the PubMed database from inception through December 2012 by searching the keywords (["pregnancy]" and [generic antibiotic drug name]). Additionally, we searched clinicaltrials.gov and conducted hand searches of references from REPROTOX, TERIS, review articles, and Briggs' Drugs in Pregnancy and Lactation. METHODS OF STUDY SELECTION: Articles included in the review contain primary data related to the safety and pharmacokinetics among pregnant women of 14 antimicrobials recommended for anthrax postexposure prophylaxis and treatment (amoxicillin, ampicillin, chloramphenicol, clindamycin, ciprofloxacin, doripenem, doxycycline, levofloxacin, linezolid, meropenem, moxifloxacin, penicillin, rifampin, and vancomycin). TABULATION, INTEGRATION, AND RESULTS: The PubMed search identified 3,850 articles for review. Reference hand searching yielded nine additional articles. In total, 112 articles met the inclusion criteria. CONCLUSIONS: Overall, safety and pharmacokinetic information is limited for these antimicrobials. Although small increases in risks for certain anomalies have been observed with some antimicrobials recommended for prophylaxis and treatment of anthrax, the absolute risk of these antimicrobials appears low. Given the high morbidity and mortality associated with anthrax, antimicrobials should be dosed appropriately to ensure that antibiotic levels can be achieved and sustained. Dosing adjustments may be necessary for the β-lactam antimicrobials and the fluoroquinolones to achieve therapeutic levels in pregnant women. Data indicate that the β-lactam antimicrobials, the fluoroquinolones, and, to a lesser extent, clindamycin enter the fetal compartment, an important consideration in the treatment of anthrax, because these antimicrobials may provide additional fetal benefit in the second and third trimesters of pregnancy.
This prospective, double-masked, randomized study was performed in 14 centers throughout Asia (The Philippines and Thailand), Latin America (Mexico, Peru, Chile, and Venezuela), and Europe (Poland, Hungary, and the Czech Republic). Outpatients with acute mild-to-moderate skin and soft-tissue infections (cellulitis, impetigo, folliculitis, furunculosis and carbuncles without surgical incision, and skin wound infections from trauma) were randomly assigned to one of the following regimens for a total of 7 to 14 days: (1) clindamycin 150 mg four times daily (QID) (CLIN 150); (2) clindamycin 300 mg twice daily (BID) (CLIN 300); or (3) dicloxacillin 250 mg QID (DICLOX). Patients were assessed clinically and bacteriologically at the end of treatment and 2 to 3 weeks after treatment. Study variables included clinical and bacteriologic outcomes. No statistically significant differences in any of the study variables were noted between the treatment groups either at the end of therapy or at follow-up 2 to 3 weeks later. In addition, no statistically significant differences were noted between the three groups regarding adverse events; two patients in the CLIN 150 group had serious adverse events (cachexia due to malnutrition and allergic dermatitis), but both problems were treated and the patients completed the study. Based on these results, we conclude that the two regimens of oral clindamycin showed rates of clinical and microbiologic efficacy similar to those of the standard regimen of oral dicloxacillin.
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