What Is A Black Box Warning Label

Food and Drug Administration (FDA)

We often refer to “black box warning” labels when discussing the side effects of drugs. But what is a black box warning label? Why is it so important?

A black box warning label is the strongest warning the Food and Drug Administration (FDA) can place on a drug. They make companies put black box warning labels on drugs that show evidence of severe and life-threatening risks.

How can you identify a drug with a black box warning? A black box warning looks exactly like you would imagine – a black box on the product packaging with text inside describing the serious side effects.

In order for the FDA to require a black box warning label, they have to confirm the potential side effects the drugs cause through research and/or clinical data.

Warnings can be put on a drug that is new to the market that already shows hazardous health risks. Or a drug can already be on the market and new findings can suggest it has serious risks that require a black box warning.

Many types of drugs have black box warnings. The most prescribed class of antibiotics – fluoroquinolones (Cipro, Levaquin and Avelox) – have a black box warning for serious nerve damage and tendon rupture.

Popular heartburn drugs including Nexium, Prilosec and Prevacid, have a black box warning for several side effects.

Patients and doctors rely on proper warning labels on drugs. Black box warning labels are one way to keep the public safe, but they are often added long after the drug has been on the market and many people have suffered serious side effects. Drugs that caused serious side effects without providing proper warnings are often the subject of dangerous drug lawsuits.

Always be sure to read the warning labels on your medication and talk to you doctor to make sure the benefits outweigh the risks.