Drug labels updated for doxycycline, clindamycin, and caffeine citrate

April 14, 2020

The National Institutes of Health has updated drug labels for doxycycline, clindamycin, and caffeine citrate. The label changes address recommended usage and dosage in pediatric populations.

Research funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), part of the National Institutes of Health, has led to label changes regarding recommended usage and dosage in pediatric populations for doxycycline, clindamycin, and caffeine citrate.

·      The revised label for doxycycline includes weight-based dosing recommendations when treating serious diseases that have no other treatment in children aged 2 to 8 years. The label revision applies to both oral and intravenous forms of the drug.

·      Clindamycin’s revised drug label provides updates to the weight-based dosing information. The revision applies to both oral and intravenous forms of the drug.

·      Caffeine citrate, which is often used off-label in infants born before 28 weeks of pregnancy, has a revised label that states the drug may be safely given to preterm infants born earlier than 28 weeks. The dose and duration also can be higher than had been recommended in the previous drug label.

 

In a news release from the NIH, Perdita Taylor-Zapata, MD, program lead for the Best Pharmaceuticals for Children Act (BPCA) at NICHD, commented on why these label changes matter. “Doctors routinely make off-label drug decisions when treating infants and children because many drugs do not have pediatric safety or dosage recommendations. The BPCA program supports research to improve the information on labels so that health care providers have clear guidance on how to prescribe drugs for their youngest patients.”

References:

1.    National Institutes of Health (NIH). NIH-funded research leads to pediatric labeling updates for doxycycline, clindamycin and caffeine citrate [news release]. Published April 2, 2020. Accessed April 14, 2020. https://www.nih.gov/news-events/news-releases/nih-funded-research-leads-pediatric-labeling-updates-doxycycline-clindamycin-caffeine-citrate