Drug safety- FDA concern about black box warning

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terminology

Adverse

drug reaction

An adverse drug

reaction, also called a side effect, is any undesirable experience associated

with the use of a medicine in a patient. Adverse events can range from mild to

severe. Serious adverse events are those that can cause disability, are

life-threatening, result in hospitalization or death, or are birth defects.

Boxed

Warning

This type of warning is

also commonly referred to as a “black box warning.†It appears on a

prescription drug’s label and is designed to call attention to serious or

life-threatening risks.