Ciprofloxacin in pediatrics: worldwide clinical experience based on compassionate use-safety report

Hampel, Barbara; Hullmann, R; Schmidt, Hermann

doi:10.1097/00006454-199701000-00036

Cited by 143 publications

(62 citation statements)

References 6 publications

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“…Joint disorders observed in young experimental animals during experimental toxicity trials made pharmaceutical companies decide not to seek to extend fluoroquinolone indications to Pediatrics. Such side effects have also been noted in children participating on clinical trials [81][82][83] and, indeed, among all possible adverse effects of the use of fluoroquinolones, only musculoskeletal events are more common in children than in adults [84][85][86][87]. Based on the potential risks and benefits of prescribing fluoroquinolones to children, the American Academy of Pediatrics, as well as several experts, have suggested that fluoroquinolones only be prescribed for specific infections or as a second-line antibiotic, in the case of severe bacterial infections with proven resistance to safer drugs [88][89][90][91][92].…”

Section: Fluoroquinolonesmentioning

confidence: 78%

Antibiotics for the empirical treatment of acute infectious diarrhea in children

Diniz-Santos¹,

Silva²,

Silva³

2006

Braz J Infect Dis

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While the routine use of antibiotics for infectious diarrhea in children must be avoided, because it brings little benefit in most cases and is associated with the risk of increasing antimicrobial resistance, selected cases may require antimicrobial therapy, and the choice of the antimicrobial agent often has to be made empirically. Physicians prescribing antimicrobials in such a setting have not only to be aware of the most likely pathogens, but also of their characteristic antimicrobial susceptibility pattern and the safety profile of the various drugs. We reviewed the literature on the use of ampicillin, beta-lactamase inhibitors, trimethoprim-sulfamethoxazole, chloramphenicol, tetracyclines, nalidixic acid, fluoroquinolones, third-generation cephalosporins, macrolides, metronidazole and malabsorbed agents in the setting of acute infectious diarrhea, and we evaluated the available information, seeking to apply it to empirical use, highlighting clinically-useful pharmacological information and patients' and pathogens' characteristics that must be taken into account for decisions about antimicrobial therapy.

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Section: Fluoroquinolonesmentioning

confidence: 78%

Antibiotics for the empirical treatment of acute infectious diarrhea in children

Diniz-Santos¹,

Silva²,

Silva³

2006

Braz J Infect Dis

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“…It was concluded that according to certain statistical equations, the maximum risk for the occurrence of chondrotoxicity, as seen in juvenile animals, would be not greater than 1 in 2348 patients (3 in 7045) or ~0.04%. With respect to the incidence of adverse reactions, in 1795 case report forms for children receiving ciprofloxacin, which were collected up to the end of 1994 by Bayer Corporation (Germany) 62,63 , arthralgia with and without clinical signs of arthritis occurred in 31 of 2030 treatment courses (1.5%). From this data, quinolones seem safe for children and adolescents.…”

Section: Osteochondrosismentioning

confidence: 99%

Chondrotoxicity of Quinolone Antimicrobial Agents

Kato

2008

J Toxicol Pathol

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Quinolone antimicrobial agents induce two types of histological changes in the articular cartilage of synovial joints in immature, but not mature, laboratory animals. The first is cavity formation in the middle zone of the articular cartilage in animals of all species examined so far, and this can be induced by a single or several daily doses. The second is osteochondrotic lesions in the caudal femoral condyles of rats when subchronic or chronic treatment is started at a juvenile age, but there seems to be only one reference for this effect. The development process of cavity formation is as follows. Degeneration and necrosis of chondrocytes are first observed, and the surrounding matrix becomes edematous with demasked collagen fibrils and decreased safranin O stainability. A flat cleft or cavity is then formed in the edematous cartilage, and erosion is sometimes produced by detachment of the cavity outer wall. The potency of quinolones to form chelate complexes with Mg 2+ is discussed as causal for cavity formation. This could lead to Mg 2+ deficiency in the cartilage, resulting in integrin alteration and further radical formation that can finally induce cartilage lesions. On the other hand, an early change of osteochondrosis is a thickened middle zone of the articular cartilage with a thinned deep zone. The thickened cartilage protrudes into the epiphysis and prevents age-dependent thinning of the cartilage. In advanced cases, fissures are formed in the bottom of the thickened cartilage, and extension of the fissures to the cartilage surface induces detachment of the cartilage, subchondral bone necrosis and fibrotic lesions in the marrow space. The lesions are considered to be caused by quinolone-induced inhibition of the differentiation of chondrocytes in the middle zone into those in the deep zone. For chondrotoxicity in juvenile animals, the pediatric use of quinolones is generally contraindicated, but whether or not chondrotoxicity could really occur in pediatric patients is still controversial. (J Toxicol Pathol 2008; 21: 123-131)

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“…Compassionate use programs for pediatric patients and off-label use by pediatricians have provided some safety data regarding ciprofloxacin use in this population. These data were published in a review [20] that reported safety information for 1795 pediatric patients. Arthralgia occurred in 1.5% of patients.…”

Section: Ciprofloxacin Safety Profilementioning

confidence: 99%

US Food and Drug Administration Approval of Ciprofloxacin Hydrochloride for Management of Postexposure Inhalational Anthrax

Meyerhoff¹,

Albrecht²,

Meyer³

et al. 2004

Clinical Infectious Diseases

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In August 2000, the US Food and Drug Administration (FDA) approved ciprofloxacin hydrochloride (Cipro; Bayer; hereafter, ciprofloxacin) for management of postexposure inhalational anthrax. This was the first antimicrobial drug approved by the FDA for treating infection due to a biological agent used intentionally. The anthrax attacks of 2001 underscore the imperative that safe and effective drugs to treat such infections be readily available in the United States. The approval of ciprofloxacin, made on the basis of a surrogate human marker of efficacy, made extensive use of data from an animal model of disease. This represents a new direction in the development of efficacy data used in support of drug approval. This report is an account of the data used in making a federal regulatory decision of significant public health importance. Its purpose is to provide

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Ciprofloxacin in pediatrics: worldwide clinical experience based on compassionate use-safety report

Abstract: The adverse event pattern in children receiving ciprofloxacin in this analysis was similar to that observed in adults. Rates of reversible arthralgia were low and unchanged from previously published surveillance data in children.

Cited by 143 publications

References 6 publications

Antibiotics for the empirical treatment of acute infectious diarrhea in children

Antibiotics for the empirical treatment of acute infectious diarrhea in children

Chondrotoxicity of Quinolone Antimicrobial Agents

US Food and Drug Administration Approval of Ciprofloxacin Hydrochloride for Management of Postexposure Inhalational Anthrax

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