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3.
Pediatrics ; 116(1): 195-204, 2005 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-15995053

RESUMO

On February 2, 2004, the Food and Drug Administration organized a joint meeting of the Neuro-Psychopharmacologic Advisory Committee and Pediatric Subcommittee of the Anti-Infective Drugs Advisory Committee to examine the occurrence of suicidality in clinical trials that investigate the use of the newer antidepressant drugs in pediatric patients. Committee members reconvened on September 13-14, 2004, and concluded that there was a causal link between the newer antidepressants and pediatric suicidality. This article provides a summary of the Food and Drug Administration deliberations for the pediatric clinician. We also provide research, regulation, education, and practice implications for care for children and adolescents who may be eligible for treatment with these medications.


Assuntos
Antidepressivos/efeitos adversos , Aprovação de Drogas , Suicídio , United States Food and Drug Administration , Adolescente , Antidepressivos/uso terapêutico , Criança , Humanos , Estados Unidos
4.
J Infect Dis ; 190(8): 1481-7, 2004 Oct 15.
Artigo em Inglês | MEDLINE | ID: mdl-15378442

RESUMO

BACKGROUND: Vancomycin is often added to therapy for meningitis caused by Streptococcus pneumoniae. Tolerant bacteria without classic resistance that escape killing by multiple antibiotics have been reported sporadically. We determined the prevalence of tolerance to vancomycin in pneumococci and its effect on the outcome of meningitis. METHODS: Archival samples of 215 nasopharyngeal (NP) and 113 meningitis isolates were tested for the killing efficacy of vancomycin. Specific DNA sequence changes in a transporter locus were identified for tolerant isolates. Similar tests were conducted prospectively on 517 NP isolates from healthy children. RESULTS: In archival isolates, tolerance to vancomycin was detected in 3.7% of NP and 10.6% of invasive isolates. Patients with meningitis caused by tolerant isolates had a worse estimated 30-day survival than did patients with meningitis caused by nontolerant isolates (49% vs. 86%; P = .048); 62.5% of tolerant archival NP isolates harbored a specific sequence change for pep27 and vex2 (P = .021). Prospective analysis of 517 carriage isolates indicated that 8.1% were tolerant to vancomycin and that 82.1% of tolerant isolates harbored the specified marker gene sequences (P = .001). CONCLUSIONS: Tolerance to vancomycin exists in the population of pneumococci. Tolerant isolates are associated with meningitis of increased mortality, and these isolates can be tracked by specific marker sequences in 2 genes.


Assuntos
Alelos , Antibacterianos/farmacologia , Portador Sadio/microbiologia , Resistência a Medicamentos/genética , Meningite/microbiologia , Streptococcus pneumoniae/efeitos dos fármacos , Vancomicina/farmacologia , Antibacterianos/uso terapêutico , Criança , Feminino , Genes Bacterianos , Marcadores Genéticos , Humanos , Masculino , Meningite/tratamento farmacológico , Meningite/mortalidade , N-Acetil-Muramil-L-Alanina Amidase/genética , Nasofaringe/microbiologia , Polimorfismo de Nucleotídeo Único , Proteínas Quinases/genética , Streptococcus pneumoniae/genética , Streptococcus pneumoniae/isolamento & purificação , Análise de Sobrevida , Vancomicina/uso terapêutico
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