What Is A Black Box Warning?

Black Box Warnings

 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.

Bookmark and Share