Safety
Review of the five pediatric trials relied upon by the FDA to grant an extension
of pediatric exclusivity to Johnson and Johnson:
Ciprofloxacin (Cipro®) - BPCA Pediatric Studies
Summary
A Multicenter,
Randomized, Open-Label, Comparative Study to Compare the Efficacy and Safety of
Levofloxacin and Standard of Care Therapy in the Treatment of Children With
Community-Acquired Pneumonia in the Hospitalized or Outpatient Setting
Ofloxacin-induced
reversible arthropathy in a child
BMJ 1994;309:1411 (26
November, 1994) Sleep disturbance in children treated with ofloxacin
C Upton (Norfolk and Norwich Hospital, Norfolk NR1 3SR).
Fluoroquinolone
safety in pediatric patients: a prospective, multicenter, comparative cohort
study
in France.Chalumeau M, Tonnelier S, D'Athis P, Treluyer JM, Gendrel D, Breart G,
Pons G;
Pediatric Fluoroquinolone Safety Study Investigators.
Perinatal and Pediatric
Pharmacology Unit, Universite Rene-Descartes,
Hopital
Saint-Vincent-de-Paul (AP-HP), Paris, France.
Joint
tolerance of pefloxacin and ofloxacin in children and adolescents with cystic
fibrosis
Pertuiset E, Lenoir G, Jehanne M, Douchain F, Guillot M, Menkes CJ.
Service de Rhumatologie, Hopital Cochin, Paris.
Pefloxacin in the treatment of patients with mucoviscidosis][Article in Russian]
Postnikov SS, Semykin SIu, Polikarpova SV, Nazhimov VP.
Russian State Medical University, Department of Medical Genetics, Department of
Pathoanatomy
Russian Pediatric Clinical
Hospital, Municipal Clinical Hospital No. 15, Moscow.
Pefloxacin-induced arthropathy in an adolescent with brain abscess.Chang H, Chung MH, Kim JH,
Kim JH.
Department of Internal Medicine, Chungang Gil Hospital, Inchon, Republic of
Korea.
Retrospective
survey of fluoroquinolone use in children
Pariente-Khayat A, Vauzelle-Kervroedan F,
d'Athis P, Breart G, Gendrel D, Aujard
Y, Olive G, Pons G.
Departement de pharmacologie perinatale et pediatrique, hopital
Saint-Vincent-de-Paul,
universite
Rene-Descartes, Paris, France.
Excerpts from the Food And Drug Administration Anti-Infective
Drugs
Advisory Committee 62nd Meeting (Wednesday, November 19, 1997);
in regards to severe and crippling adverse reactions
in the pediatric population
Full text of the Food And Drug Administration Anti-Infective
Drugs Advisory Committee 62nd
Meeting Wednesday, November 19,
1997
PDF File
A
letter sent to Dr. McClellan,
Commissioner Food and Drug Administration
Date: 2-20-2004 By the Fluoroquinolone Toxicity Research
Foundation addressing these issues.
Response received from Frances T.
Gipson, FACHE
Office of Executive Programs Center
for Drug Evaluation and Research
In response to the above letter sent to Dr. McCellan
Ciprofloxacin Approved for Pediatric Use, an
RX for Disaster
Plant City Florida (PRWEB) 10-12-2004
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)
A
case of destructive polyarthropathy in a 17-year-old youth following
pefloxacin treatment.
Chevalier X, Albengres E, Voisin
MC, Tillement JP, Larget-Piet B.
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
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
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.
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.
"The results strongly suggest that Ciprofloxacin, given during
pregnancy, causes severe liver
damage in foetuses of Wistar albino
rats."
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 examplefor 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