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Piperacillin not associated with adverse events among neonates
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No statistically significant connections between piperacillin and adverse events, such as seizures and rashes, in infants were observed in a study of drug exposure outcomes from a national electronic health record database.
“Evaluating drug safety in infants is challenging for several reasons. Performing trials with an adequate number of infants to assess drug safety requires considerable time and resources,” Sara Salerno, PharmD, from the UNC Eshelman School of Pharmacy, and colleagues wrote. “Using electronic health record data from national databases can be a suitable approach to evaluate drug safety in infants since it can overcome many of these limitations of traditional clinical trials.”
To examine the connection between simulated piperacillin exposure in infants and adverse events, researchers analyzed EHR data from 333 neonatal ICUs managed by Pediatrix Medical Group. Infants included in the study (n=746) were treated between 1997 and 2012. The researchers used a previously published pharmacokinetic model to assess several factors, such as maximal drug concentration and adverse events.
Infants in the study cohort received 777 courses of piperacillin-tazobactam during the course of r 5,879 infant days. Regarding first drug exposure, the median age was 30 weeks gestational age and 11 days postnatal age; these infants received piperacillin-tazobactam for a median of 11 days. Most infants who were given the drug were between the ages of 3 and 29 days (82%).
The infants, who weighed a median of 1,220 g at birth, received a median dose of 225 mg/kg daily. Eighteen infants exhibited positive blood cultures while being treated, and 10% of the 673 infants who had mortality data died prior to discharge.
Clinical adverse events demonstrated in data included seizures (1.3%) and rashes (0.8%). The two most commonly reported lab adverse events included low hematocrit (35%) and thrombocytopenia (32%). These effects had no statistically significant connection with the simulated area under the concentration versus time curve or maximal drug concentration.
“In this study, piperacillin-tazobactam had a favorable safety profile in infants,” Salerno and colleagues wrote. “This is consistent with previous studies evaluating the safety of piperacillin-tazobactam in infants, however only a few studies have been performed and they have small sample sizes.” — by Katherine Bortz
Disclosure: A complete list of financial disclosures and potential conflicts of interest can be found within the study.
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