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What Does it Mean If My Medication Has a ‘Black Box Warning’?

A drug information specialist explains

Medication with extra black box warning labels on container

You heard on the news that a medicine you’re taking now has a “black box warning.” That sounds alarming, but what does it actually mean?

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Black box warnings, also called boxed warnings, are required by the U.S. Food and Drug Administration for certain medications that carry serious safety risks. Often these warnings communicate potential rare but dangerous side effects, or they may be used to communicate important instructions for safe use of the drug.

They appear printed in bold font surrounded by a black border on the insert that comes inside a medication’s packaging, and on the drug manufacturer’s website, if it has one.

Communicating risk

The warnings are intended to call attention to certain risks or instructions so that healthcare professionals will be aware of them and carefully consider them when prescribing medications to patients.

If a medication you’re taking carries risk that warrants a black box warning, that doesn’t necessarily mean that you shouldn’t take it. But the risks and benefits of a medication are something your healthcare provider should discuss with you.

“If the warnings involve a serious adverse reaction and are applicable to a particular patient, the provider should discuss them with that patient before prescribing the medication,” says registered pharmacist and drug information specialist Meghan Lehmann, Pharm.D., BCPS. “A pharmacist should reiterate applicable warnings and help address any additional questions.”

How does a medicine get this warning?

FDA often identifies safety concerns with medications through clinical trial data or through reports of so-called “adverse events” submitted to the agency by consumers and healthcare professionals.

It’s not always possible to know that those adverse events are directly caused by a medication, but if FDA identifies a serious concern, it can require a drug company to update its product’s labeling, restrict its use or, in rare cases, remove it from the market.

For example, several kinds of combination birth control pills carry a black box warning related to cardiovascular risks associated with them. The warning also strongly advises that women who use them not smoke, as cigarette smoking is known to increase the risk of those side effects.

Worried about a warning? Talk to your healthcare provider

All medications come with potential risks and benefits. If you have concerns about a medicine you’re taking, don’t delay bringing them up with a healthcare professional who can help to put them in context or discuss alternatives.

“If your prescriber or pharmacist hasn’t discussed them with you, contact either one of them for help answering any questions you might have,” Dr. Lehmann says.

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