I stumbled upon some interesting research which suggests that the class of antibiotics called FLUOROQUINOLONES (Cipro and Levofloxacin are common brands) are known to have more serious side effects than any other class of antibiotics and are suggested as an antibiotic of last resort in serious bacterial infections. This drug was developed as a weapon against Anthrax but has been used more and more frequently in simple bacterial infections which would be easily treated by another, safer antibiotic.
I was surprised by this and wanted to pass along some of the information so you can discuss this with your doctor should they suggest this class of antibiotics or ask for another one to avoid these sometimes serious adverse effects:
<a target=_blank class=ftalternatingbarlinklarge href="http://www.fqresearch.org/pdf_files/19537_Cipro_BPCA_clinical.pdf
">http://www.fqresearch.org/pdf_...pro_BPCA_clinical.pdf
</a>
_____________________________________________________
[Joint tolerance of pefloxacin and ofloxacin in children and adolescents with cystic fibrosis][Article in French]
Pertuiset E, Lenoir G, Jehanne M, Douchain F, Guillot M, Menkes CJ.
Service de Rhumatologie, Hopital Cochin, Paris.
Retrospective analysis of 63 patients with mucoviscidosis (age: 11 to 21 years), treated with pefloxacine, shows the occurrence of arthropathies ascribed to pefloxacine in 9 patients (age: 9 to 20 years), or 14% of the patients under treatment. The dose of pefloxacine was normal (9 to 16 mg/kg/day) in all cases, except one case of overdose (29 mg/kg/day). Mechanical arthralgias, affect the knees, elbows and wrists, resulting in functional discomfort, and frequently accompanied by mechanical synovial extravasation. They always subside after pefloxacine is discontinued. The role of age is essential as the incidence of arthropathies reaches 45% when pefloxacine is first administered between the ages of 15 and 20 years. Retrospective analysis of 37 patients with mucoviscidosis (age: 2 to 20 years), treated with ofloxacine, failed to show any joint complication. In this study, the best joint tolerance of ofloxacine, compared with pefloxacine is statistically significant. Arthropathies induced by pefloxacine represent an original entity which seems related to the cartilage toxicity of quinolones, observed in animal experiments, during growth.
______________________________________________________
Antibiotics to avoid - Brief Article
Pediatrics for Parents, July, 2003 by Richard J. Sagall
The Federal Drug Administration (FDA) must approve drugs before they can be prescribed by physicians. The FDA approval specifies the dosages of the drug, the specific diseases and conditions it should be used for, and the age of the patients receiving it. However, once a drug is approved for one purpose or for one age group, doctors can use the drug to treat other diseases or age groups. This type of usage is called "off-label" use.
Fluoroquinolones antibiotics include Cipro, Floxin, Levoquin, and others. The FDA has approved these drugs for many types of infections, but not for use in children under 18 years old. However, it's believed that many doctors use fluoroquinolones to treat infections in children under 18 years old. These drugs are considered to be a second line antibiotic used when the more common and safer antibiotics fail to work.
________________________________________________________
Fluoroquinolones in Pediatrics
Gendrel, D.; Moulin, F.
PAEDIATRIC drugs
2001; VOL 3; part 5
Abstract:
From MEDLINE®: The fluoroquinolones are an important group of antibiotics, which are widely used in adult patients because of their high penetration in tissues and bactericidal activity. However, they are not licensed for paediatric use (except the limited indication of Pseudomonas infection in cystic fibrosis) because of their potential to cause joint toxicity (observed in experiments using juvenile animal models). In recent years, there has been a change in the susceptibility of pathogens to widely used antibiotics; however, many of these pathogens remain sensitive to the fluoroquinolones (agents which can often be administered orally to treat severe infections). Fluoroquinolones have a number of potential indications in children: cystic fibrosis, intestinal infections due to resistant strains of Salmonella spp. and Shigella spp., severe infections due to Enterobacteriaceae (including the neonatal period), complicated urinary tract infections, the immunocompromised host, and some mycobacterial infections. The third generation fluoroquinolones have improved activity against Gram-positive bacteria and could be useful in respiratory tract, and ear, nose and throat infections in adult patients. Their potential role in routine use for paediatric patients will remain limited because of potential joint complications and the availability of other treatment options. However, available clinical data does indicate that the incidence of arthrotoxicity in children treated with ciprofloxacin appears to be the same as that in adult patients. The use of other fluoroquinolones is too rare to obtain meaningful information on their toxicity in children. For future fluoroquinolones, pneumococcal meningitis will probably be a potential indication. Despite their important activity, fluoroquinolones remain a second-line treatment in children, for use following the failure of a well established antibiotic treatment, to avoid potential adverse effects and the emergence of resistant strains.
___________________________________
Fluoroquinolone Safety in Pediatric Patients: A Prospective, Multicenter, Comparative Cohort Study in France
Martin Chalumeau, MD*,, Sylvie Tonnelier, PharmD*, Philippe d'Athis, PhD*, Jean-Marc Tréluyer, MD, PhD*, Dominique Gendrel, MD, Gérard Bréart, MD and Gérard Pons, MD, PhD* the Pediatric Fluoroquinolone Safety Study Investigators
* Perinatal and Pediatric Pharmacology Unit, Université René-Descartes, Hôpital Saint-Vincent-de-Paul (AP - HP), Paris, France
INSERM U149, Paris, France
Department of Pediatrics, Hôpital Saint-Vincent-de-Paul, Paris, France
Objective. To evaluate the safety of fluoroquinolones (FQ) in comparison with other antibiotics in pediatric patients.
Methods. A multicenter, observational, comparative cohort study was conducted between 1998 and 2000 in French pediatric departments. Patients who were receiving systemic FQ were included and matched to control patients who were receiving other antibiotics. Antibiotic-associated potential adverse events (PAEs) were recorded prospectively in both groups, and their rates were compared using univariate and multivariate analyses.
Results. Patients were recruited from 73 centers: 276 patients were exposed to FQ, and 249 composed the control group. Among patients who were exposed to FQ, 23% were younger than 2 years, 33% had cystic fibrosis, and PAEs occurred in 52 patients, leading to withdrawal for 11. The odds ratio for PAE in the FQ group was 3.7 (95% confidence interval: 1.9 - 7.5) and was not significantly modified after adjustment for potential confounders. Musculoskeletal PAEs also occurred more frequently in the FQ group (3.8%) than in controls (0.4%); they were recorded in 10 patients who were receiving standard FQ doses and were of moderate intensity and transient.
Conclusion. The rates of PAEs and musculoskeletal PAEs were higher for the FQ group than the control group. This observation supports the American Academy of Pediatrics statement restricting off-label FQ use in pediatric patients to second-line treatment in a limited number of situations.
Fluoroquinolones have an unusual side effect that other antibiotics don't have--muscle and joint pain. Sometimes these problems can be severe. The FDA found these potential side effects posed too great a risk to growing muscles and bones in children 18 and under.
A French study looked at 276 children 18 and younger who received fluoroquinolones. One third of the children had cystic fibrosis. The children were matched with 249 children on other antibiotics.
Nearly 20% (52 children) of the children taking a fluoroquinolone experienced a side effect compared to 5% (13 children) on other antibiotics. The biggest difference was in musculoskeletal pain--10 in the fluoroquinolone group compared to none in the control group. The children in the fluoroquinolone group had a higher rate of all other side effects.
Fluoroquinolones have a role in treating infections in children--but a very limited one. These drugs should not be the first antibiotic used. Other safer antibiotics should be tried. Only if they don't work should fluoroquinolones be used.
Family Practice News, 1/15/03.
COPYRIGHT 2003 Pediatrics for Parents, Inc.
COPYRIGHT 2003 Gale Group
I was surprised by this and wanted to pass along some of the information so you can discuss this with your doctor should they suggest this class of antibiotics or ask for another one to avoid these sometimes serious adverse effects:
<a target=_blank class=ftalternatingbarlinklarge href="http://www.fqresearch.org/pdf_files/19537_Cipro_BPCA_clinical.pdf
">http://www.fqresearch.org/pdf_...pro_BPCA_clinical.pdf
</a>
_____________________________________________________
[Joint tolerance of pefloxacin and ofloxacin in children and adolescents with cystic fibrosis][Article in French]
Pertuiset E, Lenoir G, Jehanne M, Douchain F, Guillot M, Menkes CJ.
Service de Rhumatologie, Hopital Cochin, Paris.
Retrospective analysis of 63 patients with mucoviscidosis (age: 11 to 21 years), treated with pefloxacine, shows the occurrence of arthropathies ascribed to pefloxacine in 9 patients (age: 9 to 20 years), or 14% of the patients under treatment. The dose of pefloxacine was normal (9 to 16 mg/kg/day) in all cases, except one case of overdose (29 mg/kg/day). Mechanical arthralgias, affect the knees, elbows and wrists, resulting in functional discomfort, and frequently accompanied by mechanical synovial extravasation. They always subside after pefloxacine is discontinued. The role of age is essential as the incidence of arthropathies reaches 45% when pefloxacine is first administered between the ages of 15 and 20 years. Retrospective analysis of 37 patients with mucoviscidosis (age: 2 to 20 years), treated with ofloxacine, failed to show any joint complication. In this study, the best joint tolerance of ofloxacine, compared with pefloxacine is statistically significant. Arthropathies induced by pefloxacine represent an original entity which seems related to the cartilage toxicity of quinolones, observed in animal experiments, during growth.
______________________________________________________
Antibiotics to avoid - Brief Article
Pediatrics for Parents, July, 2003 by Richard J. Sagall
The Federal Drug Administration (FDA) must approve drugs before they can be prescribed by physicians. The FDA approval specifies the dosages of the drug, the specific diseases and conditions it should be used for, and the age of the patients receiving it. However, once a drug is approved for one purpose or for one age group, doctors can use the drug to treat other diseases or age groups. This type of usage is called "off-label" use.
Fluoroquinolones antibiotics include Cipro, Floxin, Levoquin, and others. The FDA has approved these drugs for many types of infections, but not for use in children under 18 years old. However, it's believed that many doctors use fluoroquinolones to treat infections in children under 18 years old. These drugs are considered to be a second line antibiotic used when the more common and safer antibiotics fail to work.
________________________________________________________
Fluoroquinolones in Pediatrics
Gendrel, D.; Moulin, F.
PAEDIATRIC drugs
2001; VOL 3; part 5
Abstract:
From MEDLINE®: The fluoroquinolones are an important group of antibiotics, which are widely used in adult patients because of their high penetration in tissues and bactericidal activity. However, they are not licensed for paediatric use (except the limited indication of Pseudomonas infection in cystic fibrosis) because of their potential to cause joint toxicity (observed in experiments using juvenile animal models). In recent years, there has been a change in the susceptibility of pathogens to widely used antibiotics; however, many of these pathogens remain sensitive to the fluoroquinolones (agents which can often be administered orally to treat severe infections). Fluoroquinolones have a number of potential indications in children: cystic fibrosis, intestinal infections due to resistant strains of Salmonella spp. and Shigella spp., severe infections due to Enterobacteriaceae (including the neonatal period), complicated urinary tract infections, the immunocompromised host, and some mycobacterial infections. The third generation fluoroquinolones have improved activity against Gram-positive bacteria and could be useful in respiratory tract, and ear, nose and throat infections in adult patients. Their potential role in routine use for paediatric patients will remain limited because of potential joint complications and the availability of other treatment options. However, available clinical data does indicate that the incidence of arthrotoxicity in children treated with ciprofloxacin appears to be the same as that in adult patients. The use of other fluoroquinolones is too rare to obtain meaningful information on their toxicity in children. For future fluoroquinolones, pneumococcal meningitis will probably be a potential indication. Despite their important activity, fluoroquinolones remain a second-line treatment in children, for use following the failure of a well established antibiotic treatment, to avoid potential adverse effects and the emergence of resistant strains.
___________________________________
Fluoroquinolone Safety in Pediatric Patients: A Prospective, Multicenter, Comparative Cohort Study in France
Martin Chalumeau, MD*,, Sylvie Tonnelier, PharmD*, Philippe d'Athis, PhD*, Jean-Marc Tréluyer, MD, PhD*, Dominique Gendrel, MD, Gérard Bréart, MD and Gérard Pons, MD, PhD* the Pediatric Fluoroquinolone Safety Study Investigators
* Perinatal and Pediatric Pharmacology Unit, Université René-Descartes, Hôpital Saint-Vincent-de-Paul (AP - HP), Paris, France
INSERM U149, Paris, France
Department of Pediatrics, Hôpital Saint-Vincent-de-Paul, Paris, France
Objective. To evaluate the safety of fluoroquinolones (FQ) in comparison with other antibiotics in pediatric patients.
Methods. A multicenter, observational, comparative cohort study was conducted between 1998 and 2000 in French pediatric departments. Patients who were receiving systemic FQ were included and matched to control patients who were receiving other antibiotics. Antibiotic-associated potential adverse events (PAEs) were recorded prospectively in both groups, and their rates were compared using univariate and multivariate analyses.
Results. Patients were recruited from 73 centers: 276 patients were exposed to FQ, and 249 composed the control group. Among patients who were exposed to FQ, 23% were younger than 2 years, 33% had cystic fibrosis, and PAEs occurred in 52 patients, leading to withdrawal for 11. The odds ratio for PAE in the FQ group was 3.7 (95% confidence interval: 1.9 - 7.5) and was not significantly modified after adjustment for potential confounders. Musculoskeletal PAEs also occurred more frequently in the FQ group (3.8%) than in controls (0.4%); they were recorded in 10 patients who were receiving standard FQ doses and were of moderate intensity and transient.
Conclusion. The rates of PAEs and musculoskeletal PAEs were higher for the FQ group than the control group. This observation supports the American Academy of Pediatrics statement restricting off-label FQ use in pediatric patients to second-line treatment in a limited number of situations.
Fluoroquinolones have an unusual side effect that other antibiotics don't have--muscle and joint pain. Sometimes these problems can be severe. The FDA found these potential side effects posed too great a risk to growing muscles and bones in children 18 and under.
A French study looked at 276 children 18 and younger who received fluoroquinolones. One third of the children had cystic fibrosis. The children were matched with 249 children on other antibiotics.
Nearly 20% (52 children) of the children taking a fluoroquinolone experienced a side effect compared to 5% (13 children) on other antibiotics. The biggest difference was in musculoskeletal pain--10 in the fluoroquinolone group compared to none in the control group. The children in the fluoroquinolone group had a higher rate of all other side effects.
Fluoroquinolones have a role in treating infections in children--but a very limited one. These drugs should not be the first antibiotic used. Other safer antibiotics should be tried. Only if they don't work should fluoroquinolones be used.
Family Practice News, 1/15/03.
COPYRIGHT 2003 Pediatrics for Parents, Inc.
COPYRIGHT 2003 Gale Group