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Black box warnings point out drugs’ possible side effects

You may have heard the term “black box warning” for some prescription medications. This doesn’t mean these drugs are packed in black boxes.

Instead, it’s a warning to help you learn more about drugs you’re prescribed. This warning is found on the package insert, outlined by a black border or “box,” and is meant to inform you of potential serious or life-threatening risks.

Marshfield Clinic Clinical Pharmacist and Medication Safety Coordinator Luanne Sojka, Pharm.D., BCPS, explains this is the most severe warning given by the Food and Drug Administration (FDA), used only when there’s evidence of a serious hazard with a drug.

“Every medication has potential risk. Most often, the benefit outweighs the risk,” Sojka said. “With ‘black box’ warnings, the FDA has decided to highlight significant and potentially life-threatening risks.”

Shelf full of prescription drugs, pill bottles - Illustration - Black box warnings
Black box warnings help you learn more about drugs you’re prescribed.

Warning informs you of issues

Over time, a number of drugs and drug categories have been given this or other warnings meant to inform consumers about possible issues when taking a prescribed medication. Medication guides, written and approved by the FDA, also are given to patients with risk information on a certain drug or drug class.

A black box warning can be added or removed at any point within a medication’s lifetime. Some immediately come with a black box warning while others, like antidepressants, get a warning after years on the market.

“It is important to remember, just because you may have taken a medication for a long time doesn’t mean there’s not new information available,” she said.

Sojka encourages patients to talk with members of their health care team about medications, black box warnings and possible adverse reactions.

She used antidepressants as an example. Widely used by all ages, the FDA has a black box warning on this class of medications regarding potential of increased risk of suicidal thoughts. Every antidepressant has a black box warning regarding suicidality.

When patients are informed of the risks, if they experience changes in thought or behavior, we hope they will talk with their providers,” Sojka said. “Information is powerful. Black box warnings empower the patient to start the conversation with health care providers if and when they observe something within that warning.”

Don’t hesitate to ask questions

When picking up prescriptions, Sojka recommends taking time to pause, listen to the pharmacist and ask questions.

“Pharmacists understand patients receive a lot of information about their care and treatment at each visit with their providers,” she said. “There is only so much information we can take in at a doctor’s appointment, so having a second chance for a conversation at the point of picking up your medication is so valuable.”

To learn more about black box warnings, visit: Institute for Safe Medication Practices or ConsumerSafety.org.

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