In the Journals

Adverse events with moxifloxacin rarely result in treatment discontinuations in children

Photo of Avika Dixit
Avika Dixit

The use of moxifloxacin — a fluoroquinolone not currently approved by the FDA for use in children — is commonly associated with adverse events in the pediatric population, according to researchers. However, these reactions are rarely serious enough to discontinue treatment, they said.

“Generally, moxifloxacin is rarely used in the pediatric population for systemic therapy, and use is considered off-label,” Avika Dixit, MBBS, MPH, MBI, FAAP, assistant in medicine in the division of infectious diseases at Boston Children’s Hospital, told Infectious Diseases in Children. “Although not FDA-approved for use in this population, it can be helpful in treating certain infections because it is absorbed well when taken orally and has a broad spectrum of activity. However, the antibiotic has not been well studied in children, leading to a lack of data on dosing and safety.”

Dixit and colleagues wrote that this antibiotic is used for the prevention and treatment of several diseases, including multidrug-resistant tuberculosis and other mycobacterial infections, atypical pneumonia and neonatal Mycoplasma hominis meningitis. The researchers also noted that moxifloxacin is effective against several gram-positive, gram-negative and anaerobic bacteria.

Because data concerning the drug’s safety in children are limited, the researchers assessed the systemic moxifloxacin use in pediatric patients aged younger than 18 years. All patients were administered the antibiotic orally or intravenously at Boston Children’s Hospital between January 2011 and July 2016.

Moxifloxacin was given to 221 patients (average age, 10.4 years) who received 300 courses of the drug. Adverse events were commonly reported, with 65% of courses resulting in one or more. However, the researchers said the antibiotic was “generally safe and well tolerated,” with an overall rate of moxifloxacin-associated adverse events of only 14.3%.

The most commonly reported adverse events associated with pediatric moxifloxacin use included corrected QT interval (QTc) prolongation (6% of courses), transaminase level elevation (2.3% of courses) and higher bilirubin levels (1% of courses).

Eighteen courses were discontinued during the study period, according to the researchers. Pediatric patients who received consultation with an infectious disease pharmacist were more likely to be monitored for QTc and transaminase levels, they said.

“Because there is a lack of data on [moxifloxacin] use in children and known risk for serious adverse events based on its use in adults, consultation with a pediatric infectious disease specialist should be sought when this antibiotic is being considered,” Dixit said. “Baseline lab parameters, including a complete blood count, basic metabolic panel and liver function tests, should be obtained and monitored throughout therapy. The frequency of ongoing monitoring is typically determined based on individual patient risks and planned duration of therapy.” by Katherine Bortz

Disclosures: The authors report no relevant financial disclosures.

Photo of Avika Dixit
Avika Dixit

The use of moxifloxacin — a fluoroquinolone not currently approved by the FDA for use in children — is commonly associated with adverse events in the pediatric population, according to researchers. However, these reactions are rarely serious enough to discontinue treatment, they said.

“Generally, moxifloxacin is rarely used in the pediatric population for systemic therapy, and use is considered off-label,” Avika Dixit, MBBS, MPH, MBI, FAAP, assistant in medicine in the division of infectious diseases at Boston Children’s Hospital, told Infectious Diseases in Children. “Although not FDA-approved for use in this population, it can be helpful in treating certain infections because it is absorbed well when taken orally and has a broad spectrum of activity. However, the antibiotic has not been well studied in children, leading to a lack of data on dosing and safety.”

Dixit and colleagues wrote that this antibiotic is used for the prevention and treatment of several diseases, including multidrug-resistant tuberculosis and other mycobacterial infections, atypical pneumonia and neonatal Mycoplasma hominis meningitis. The researchers also noted that moxifloxacin is effective against several gram-positive, gram-negative and anaerobic bacteria.

Because data concerning the drug’s safety in children are limited, the researchers assessed the systemic moxifloxacin use in pediatric patients aged younger than 18 years. All patients were administered the antibiotic orally or intravenously at Boston Children’s Hospital between January 2011 and July 2016.

Moxifloxacin was given to 221 patients (average age, 10.4 years) who received 300 courses of the drug. Adverse events were commonly reported, with 65% of courses resulting in one or more. However, the researchers said the antibiotic was “generally safe and well tolerated,” with an overall rate of moxifloxacin-associated adverse events of only 14.3%.

The most commonly reported adverse events associated with pediatric moxifloxacin use included corrected QT interval (QTc) prolongation (6% of courses), transaminase level elevation (2.3% of courses) and higher bilirubin levels (1% of courses).

Eighteen courses were discontinued during the study period, according to the researchers. Pediatric patients who received consultation with an infectious disease pharmacist were more likely to be monitored for QTc and transaminase levels, they said.

“Because there is a lack of data on [moxifloxacin] use in children and known risk for serious adverse events based on its use in adults, consultation with a pediatric infectious disease specialist should be sought when this antibiotic is being considered,” Dixit said. “Baseline lab parameters, including a complete blood count, basic metabolic panel and liver function tests, should be obtained and monitored throughout therapy. The frequency of ongoing monitoring is typically determined based on individual patient risks and planned duration of therapy.” by Katherine Bortz

Disclosures: The authors report no relevant financial disclosures.