The only
indications for which a fluoroquinolone (ie, ciprofloxacin) is
licensed by the US Food and Drug Administration for use in patients
younger than 18 years
Ciprofloxacin for the Treatmentof Uncomplicated Gonorrhea Infectionin
Adolescents: Does the Benefit Outweigh the Risk?
(PDF File Adobe Reader Required to view)
ODS POSTMARKETING SAFETY REVIEW
Consult: One-Year Post Pediatric Exclusivity Postmarketing
Adverse Events Review Ciprofloxacin
NDA: 19-537, 19-847 PDF File
(In summary, in the 13-month period of review the 17
unique pediatric cases showed mostly labeled hematological,
musculoskeletal, allergic/hypersensitivity, and CNS events...
because one report was concerning due to the patient requiring a
wheelchair after developing drug associated symptoms...)
Further analysis
of the risk of adverse birth outcome after maternal use of
fluoroquinolones
Pediatric Adverse Drug Reactions associated with Levofloxacin and
Ciprofloxacin therapy as reported to the FDA (1997/2001)
Yet another pediatric trial:
Quinolones no better than standard antibiotics when treating
treating typhoid and paratyphoid fever with Norfloxacin
having more clinical failures than other fluoroquinolones.
South African
Treatment Guidelines allow the use of fluoroquinolones in the
pediatric population: "The BCG vaccine is given routinely to
infants in settings where TB is endemic and is recommended for
HIV-positive children in South African treatment guidelines....In
HIV-positive children local or systemic disease should be treated with
a four drug TB regimen of isoniazid, rifampicin, ethambutol,
pyrazinamide, and ciprofloxacin or ofloxacin."
Arthralgia associated with
the pediatric use of Gatifloxacin. "Six patients (2.2%) in the
gatifloxacin group...developed transient symptoms of ...arthralgia."
Fungal Infections Associated with
Ofloxacin. "An increase
in incidence of fungal infections of the ear were found in the period
after widespread use of ofloxacin began."
University Of Virginia Health System
Date: 2002-10-11 Antibiotics Not Always Beneficial For Childhood
Ear Infections
Mutagenicity,
Pregnancy/Reproduction and breast feeding.
Severe ciprofloxacin-associated
pseudomembranous colitis in an eight-year-old child
Severe Adverse Drug
Reactions associated with the use of Fluoroquinolones in the pediatric
population, including numerous fatalities.
Acute Reversible Arthropathy in a Pediatric
Patient With Cancer Treated With a Short Course of Ciprofloxacin for
Febrile Neutropenia.
Antibiotics to avoid - Brief Article
Pediatrics for Parents, July, 2003 by Richard
J. Sagall
Effects of ciprofloxacin on foetal hepatocytes.
"The results strongly suggest that Ciprofloxacin, given during
pregnancy, causes severe liver damage in foetuses of Wistar albino
rats."
J Pak Med Assoc. 2003 Oct;53(10):448-50. Channa MA, Janjua MZ.
Department of Anatomy, Basic Medical Sciences Institute, Jinnah
Postgraduate Medical Centre, Karachi.
Levofloxacin secretion
in breast milk: a case report. Cahill JB Jr, Bailey EM, Chien S,
Johnson GM. Division of Neonatology, Department of Pediatrics,
Medical University of South Carolina, Charleston, South Carolina
29425, USA. cahilljb@musc.edu
Breast feeding and fluoroquinolones
Sudden death after
intravenous ciprofloxacin Adverse drug reaction monitoring of
ciprofloxacin in pediatric practice.
Fluorine level
in the bone and cartilage in children treated with ciprofloxacin (data
obtained from the femur distal part)
Benign
intracranial hypertension after ciprofloxacin administration.
Safety of
ciprofloxacin in children
Fluoroquinolones
in Pediatrics
Johnson & Johnson Pharmaceutical Research and Development study shows
fluoroquinolones therapy
in pediatrics results in less than 1% having tendon, joint disorders
associated with selected Fluoroquinolone when used in children
These
medications are known to cause harm in children and
fetuses and to
affect the growth of bones, teeth, and cartilage. FQs
are NOT
currently approved by the FDA for
pediatric
applications because of drug-associated articular cartilage damage
noted in animal studies
The Risk
of the Hemolytic–Uremic Syndrome after Antibiotic Treatment of
Escherichia coli [Pediatric Study]
Clinical Use of
Fluoroquinolones in Children
Abdullah A Alghasham and Milap C Nahata
O B J E C T I V E: To review the pharmacokinetics, efficacy, and
safety of fluoroquinolones in children.
So what can you get from your Pediatrician
besides a healthy child? Off label Antibiotics!!!
Rationale for Use of Fluoroquinolones in
Pediatric UTIs
Barr Laboratories
Inc. will be able to continue to market a
generic version of the antibiotic Cipro for children in the United
States
Fluoroquinolone Safety in
Pediatric Patients: A Prospective, Multicenter, Comparative Cohort
Study in France
Fluoroquinolones given to
children result in higher rates of adverse events than other
antibiotics
Children as a
special population at risk--quinolones as an example
for xenobiotics exhibiting skeletal toxicity.
Stahlmann R
Effects of ciprofloxacin on foetal hepatocytes.
Alfaham M, Holt ME, Goodchild MC. Arthropathy in a patient with
cystic fibrosis taking ciprofloxacin. Br Med J 1987; 295: 699.
No Abstract or Article available at this time
Jawad ASM. Cystic fibrosis and drug-induced arthropathy. Br J
Rheumatol 1989; 28(2): 179-80.
No Abstract or Article available at this time
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