Drugs Given to Children at U.S. Hospitals Are Mostly Off-Label

PHILADELPHIA, March 8 — Nearly 80% of hospitalized children are medicated with drugs that have not been approved by the FDA for pediatric use, according to a study here.

Action Points

  • Explain to patients that off-label drug use among children at U.S. hospitals is common because many drugs have not been tested in any pediatric population for any indication.

“Though off-label drug use also occurs in adults, the problem is substantially greater in children because many drugs have not been tested in any pediatric population for any indication,” said Samir S. Shah, M.D., of the Children’s Hospital of Philadelphia.

Central and autonomic nervous system drugs, such as morphine, were the most common to be given off-label, Dr. Shah and colleagues reported in the March issue of Archives of Pediatric and Adolescent Medicine. Such drugs were given to 66% of the hospitalized children.  Read More…

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