Washington, DC—Some drugs commonly used in pediatric patients now have updated drug labels providing better information for prescribers and users.

The labels now specify recommended usage and dosage in pediatric populations, according to the FDA.

Research funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), part of the National Institutes of Health, was used to develop the information leading to the changes. “Doctors routinely make off-label drug decisions when treating infants and children because many drugs do not have pediatric safety or dosage recommendations,” said Perdita Taylor-Zapata, MD, program lead for the Best Pharmaceuticals for Children Act (BPCA) at NICHD. “The BPCA program supports research to improve the information on labels so that healthcare providers have clear guidance on how to prescribe drugs for their youngest patients.”   

Products with updated labeling include:
• Doxycycline, an antibiotic used to treat life-threatening infectious diseases, including Rocky Mountain spotted fever and anthrax. The revised drug label now includes weight-based dosing recommendations for treating serious diseases that currently have no alternative therapies for children aged 2 to 8 years. The new recommendations apply to oral and IV forms of the drug.
• Clindamycin, prescribed to treat various infections in children, including lower-respiratory tract infections, intra-abdominal infections, sepsis, and bone and joint infections. The revised drug label updates weight-based dosing information for oral and IV forms of the drug.
• Caffeine citrate, prescribed to treat apnea of prematurity, a breathing disorder that occurs in premature infants. The medication is commonly used off-label for infants born earlier than 28 weeks of pregnancy even though the previous label only offered guidance for infants born 28 to 32 weeks of pregnancy (a full-term pregnancy is 39 weeks). The revised label indicates that the drug may safely be given to preterm infants born earlier than 28 weeks, and the dose and duration may be higher and longer than what the previous label recommended.

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