What is a black box warning on a prescription drug?
A black box warning is the strictest warning put in the labeling of prescription drugs or drug
products by the Food and Drug Administration (FDA) when there is reasonable evidence of an
association of a serious hazard with the drug. It is basically a warning with a black box
around it, hence the name. Having the black box around the warning means that an adverse
reaction to the drug may lead to death or serious injury. It's based on clinical data or
serious animal toxicity data in the absence of clinical data. Sometimes a black box warning is
necessary at the time a new drug is approved. More commonly however, it is added after the drug
has been approved and the FDA has received reports of adverse events. After the FDA confirms
the serious risk, then depending on the severity of adverse event and in collaboration with the
pharmaceutical company, a boxed warning is implemented. This does not mean the drug is
contraindicated in any way, but just a means of communication from the FDA to prescribers to
highlight the risk. As with any drug, there is a risk and benefit associated with taking the
drug. The black box warning is to alert prescribers of the potential risk in prescribing this
drug so they can take it into consideration. If you have concerns regarding your prescription,
discuss with your physician.
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