Drug Labels Still Lack Infant Info, Study Finds

Drug Labels Still Lack Infant Info, Study Finds

MONDAY, Dec. 9, 2013 (HealthDay News) -- Drug labels often lack infant-specific information, despite U.S. government legislation encouraging drug studies involving children, a new study finds.

The research focused on neonates, who are infants up to 28 days of age. They are at high risk for harmful effects from drugs. The unique ways in which their bodies work makes it difficult to determine how drugs might affect them by analyzing data involving older patients, according to background information in the study.

"The scientific and clinical research community will need to work together with the FDA to conduct essential neonatal studies," said Dr. Matthew Laughon, of the University of North Carolina at Chapel Hill, and colleagues.

The researchers reviewed 28 drug studies that included neonates and were conducted as a result of federal legislation, along with 24 related labeling changes.

The results showed that 11 of the 24 neonatal labeling changes made it clear that the drug was approved for use in neonates.

The investigators also found that 13 of the 28 drugs were not used in neonatal intensive care units and that eight of the drugs were used in fewer than 60 neonates, according to the study published online Dec. 9 in the journal JAMA Pediatrics.

"Because of these challenges of performing clinical trials in infants, few labeling changes have included infant-specific information. Novel trial designs need to be developed and appropriate study end points must be identified and validated," Laughon and colleagues wrote in a journal news release.

"Education of parents and caregivers regarding the need for studies of drugs being given to neonates will also increase trial success," they added.

More information

The U.S. National Library of Medicine has more about children and medicines.

SOURCE: JAMA Pediatrics, news release, Dec. 9, 2013

Today's Interactive Tools

The third-party content provided in the Health Library of phoebeputney.com is for informational purposes only and is not designed to diagnose or treat a health problem or disease, or replace the professional medical advice you receive from your physician. If you or your child has or suspect you may have a health problem, please consult your primary care physician. If you or your child may have a medical emergency, call your doctor or 911 or other emergency health care provider immediately in the United States or the appropriate health agency of your country. For more information regarding site usage, please visit: Privacy Information, Terms of Use or Disclaimer.