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What Is A Black Box Warning?

When reading about dangerous products or defective over-the-counter drugs, you may come across the phrase “black box warning” or “black label warning.” But what does this phrase mean, and how can it help protect you from dangerous side affects and adverse drug reactions?

Black box warnings are often located on over-the-counter medications and medical products as well as prescription drugs. They are called “black box” warnings because they are often located in boxes with a think dark border in hopes that those using the product will see the warnings. While pharmaceutical companies can choose to put whatever information they would like in black boxes, the Food & Drug Administration can require that drug companies include certain safety information on products that pose specific dangers to consumers.

Generally, all of the dangers and warnings associated with a drug can be found in the black box warning label of a drug, and the black box warning is the strongest warning that the FDA requires of drug companies selling goods in America.

Black box warnings are based on extensive scientific studies and research that links the drug with dangerous side effects, dangerous drug combinations, and possible drug reactions. A black box warning may list complications that come with the prescription drug use, possible chronic conditions that could develop with drug use, and dangerous side-effects such as heart attacks, stroke risk, bone density loss, suicide risk, or even the formation of dangerous behaviors such as gambling addictions.

Before taking any drug, be sure to carefully read the black box warning and discuss any concerns you may have with your doctor. Also, be aware of any changes or side effects you may feel when you begin taking any new medication.