Drugs are regularly prescribed to children in outpatient care even though they have not been licensed for use with children.
"Off-label use" is a common practice -- it means that a drug is used outside the approved characteristic, such as age. But safety is not always guaranteed with off-label use.
A study in Germany showed that only 42.5 percent of prescriptions for neonates were approved and only 82.8 percent for babies.
For many drugs, it was not even possible for physicians to tell the medications were not approved based on the Summary of Product Characteristics (SPC) -- the information given to physicians for the medication in question. Because of the lack of information, it was impossible to determine the licensing status for one drug in five.