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Pediatric Research | See downloads for: Adobe Files |
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Severe Adverse Drug Reactions
associated with the use of Fluoroquinolones in the pediatric
population, including numerous fatalities.
Author: Fluoroquinolone Toxicity Research Foundation 5/2005 www.fqresearch.orgA review of the MedWatch database (1997/2001) reveals severe, life threatening and perhaps even fatal adverse reactions to the use of Ciprofloxacin and Levofloxacin in the pediatric population. Such reactions involved the full range of the body systems. Twenty-five reports were found in which Death was listed as an outcome (Levofloxacin n/2 Ciprofloxacin n/23). Due to the archaic manner in which the FDA records such reports the true number of deaths associated with these two drugs cannot be readily determined. Several reports appear to be duplicates but the reporting numbers and the date such reports were received are different. Whether the underlying disease state was responsible or whether or not the drug involved was the root cause is not discernable either. One report of Steven Johnson Syndrome was attributed to Levofloxacin. Ten cases of Anaphylactic Reactions (Levofloxacin n/5 Ciprofloxacin n/5) were also reported together with heart problems (Levofloxacin n/4), liver problems (Ciprofloxacin n/11), kidney problems (Ciprofloxacin n/13), blood disorders (Ciprofloxacin n/10), severe rashes (Ciprofloxacin n/16). With levofloxacin we found vasculitis (n/2), acute respiratory distress (n/2) and birth defects (n/1). With ciprofloxacin we found reports involving vision and hearing disorders (n/8). Most disturbing are the thirty-five reports involving tendon disorders, (levofloxacin n/18, ciprofloxacin n/17) together with thirty-three reports involving the central and peripheral nervous system. (levofloxacin n/13, ciprofloxacin n/20). Other than fatalities, the highest number of reports involve tendons, central and peripheral nervous systems, liver and kidney damage as well as severe skin disorders (SJS, TENs). It appears that the pediatric population is at the same risk as the adult population to the various severe adverse drug reactions associated with fluoroquinolone therapy. Due to the complications of tendon injury, (which has been reported as being non-abating and even resulting in permanent disability), together with the risk of experiencing irreversible peripheral neuropathy, physicians are advised to heed the current ban on the indiscriminate use of fluoroquinolones in the pediatric population. Although the FDA has recently approved the use of Ciprofloxacin involving specific disease states within the pediatric population (as well as encouraging clinical trials involving levofloxacin), we do not feel that the risk/benefit justifies such actions. In fact we are of the opinion that the FDA should ban the indiscriminate use of the drugs found within this class and impose restrictions that such drugs should only be utilized when the life or limb of the pediatric patient is at risk. As stated earlier the MedWatch database cannot be relied upon to accurately represent such adverse reactions or to reveal a cause and effect. The MedWatch database can only be used to point to disturbing trends that require intervention by the FDA. The numbers reported above are sum totals found within this database and do not accurately reflect the true numbers of such events nor do they represent a proven relationship between the events being reported and the drugs involved. Adverse drug reactions to Levofloxacin in the Pediatric Population as reported to the FDA (1997-2001) (2) Deaths (1) SJS (5) Anaphylactic Reaction (18) Tendon disorders (13) CNS/PNS, Seizures, Convulsions, Insomnia, Panic Attacks (4) Heart Problems (2) Vasculitis (2) Acute Respiratory Distress (9) Misc (1) Birth Defect Adverse drug reactions to Ciprofloxacin in the Pediatric Population as reported to the FDA (1997-2001) (23) Death (20) CNS/PNS (17) Tendon and joint (16) Rash (13) Kidney (11) Liver (10) Blood Disorders (5) Anaphylactic Reaction (8) Special Senses (16) Misc/Other
The authors of this opinion article have no affiliation with any manufacturer, distributor or marketer of fluoroquinolones or any other special interest groups.
Adverse drug reactions to
Ciprofloxacin in the Pediatric Population as reported to the FDA
(1997-2001) The adverse drug reactions to
Levofloxacin in the pediatric population (1997/2001) as reported to
the FDA.
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