Black Box Warning
Not all patients react the same to pharmaceutical drugs. While a prescription drug may be effective for some patients, serious side effects may occour in others. If the FDA deems a drug as a “black box warning” drug then the FDA will require the drug have a warning of any possible adverse side effects printed on both the inside instructions and the outside packaging. A printed black box surrounds the warning; hence the name.
A black box warning is the highest warning issued by the FDA about a drug. It is the step before removing the drug from the market. A black box warning signifies how dangerous a drug can be if given to at risk patients who could develop possible adverse side effects.
