Black Box Warning

What is a Black Box Warning?

This is a warning system used by the Food and Drug Administration to alert prescribers, pharmacists and patents that this particular medication has potentially dangerous side effects.

The Black Box Warning is the highest level of warning the FDA can give to a medication.  When a medication receives a Black Box Waring it means that studies have suggested that this particular medication has potential severe or even lethal side effects.

A Black Box Warning might be added to a product by the FDA after it has been used for a series of years and through routine use it was discovered that the particular medication had serious side effects that were previously unknown.  The FDA may also require a Back Box Warning on a new medication that has potentially significant benefits while also potentially serious side effects.

The term "black box" is referring to the thick black line that borders the warning information in the medication package literature.

If you receive a medication from your pharmacy that has a Black Box Warning you will also receive a Medication Guide that discusses the warning and what it means.  Ask your pharmacist to explain the warning information and any risk vs benefits associated with this medication  If the information is not explained clearly, please ask them to repeat the information to you so you may understand it.

After discussing this with your pharmacist, don't hesitate to call your doctor and discuss the risk vs benefit with them also

It is important that you understand why you are taking your medication so that you will be motivated to follow your regimen and achieve the best possible outcome from your pharmaceutical therapy.