A decade after the Fourth Circuit’s decision, the FDA announced that a boxed warning would be added to the drug to bar it from being given to children less than two years of age.121 A boxed warning, also known as a “black box warning,”122 is the strongest type of warning that the agency can require.123 The FDA called for adding this warning to promethazine after it reviewed reports it had been receiving since 1969 about children, like Brandy Foster, suffering respiratory depression and other serious adverse effects from taking the drug. The reports attributed the deaths of seven infants to the drug.124