RELATED: COVID-19 and multisystem inflammatory syndrome in children: What parents need to know An off-label drug is a type of medication that is being used in a manner not specified in the FDA's approved packaging label criteria.
Every prescription drug marketed in the U.S. carries an individual FDA-approved label.Because many drugs have not been tested specifically for use in children, physicians will often prescribe drugs off-label to children because they lack an alternative, approved treatment.“As we search for safe and effective therapies for COVID-19, we want to make sure that we do not overlook the needs of our youngest patients who may respond differently to these drugs, compared to adults,” said Diana W.