Key takeaways:
A black box warning is the strictest and most serious type of warning that the FDA gives a medication.
A black box warning is meant to draw attention to a medication’s serious or life-threatening side effects or risks.
A medication with a black box warning can still be a viable treatment option when used appropriately and by the right population.
Not all medication side effects are created equal. Some side effects can be serious and life-threatening. Sometimes pharmaceutical companies are required to highlight them in a special box. This is called a black box warning.
A black box warning aims to bring attention to a medication’s potentially serious risks. In fact, there are hundreds of medications that carry this special type of warning. But this doesn’t mean the medication is unsafe when used and monitored appropriately.
Below we’ll discuss what an FDA black box warning means, why a medication may have one, and how it may affect you.
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What is an FDA black box warning, and what does it mean?
A black box warning is the strictest type of warning that the FDA gives a medication. It’s also called a boxed warning.
When a medication has a black box warning, that doesn’t necessarily mean you can’t take it. Its purpose is to bring attention to the major risks of a medication. Your healthcare provider can use this information to make careful decisions about who should take it.
A medication with a boxed warning may be appropriate for certain people under certain conditions.
How serious is a black box warning?
Medications may have a black box warning if they have the potential to cause serious harm, hospitalization, or even death. You should take the warnings highlighted in these boxes with the utmost importance.
Healthcare providers should take careful consideration before prescribing medications with black box warnings. This can help prevent unnecessary and potentially fatal outcomes.
Where can I find information about a medication’s black box warning?
You can find the black box warning at the top of a medication’s package insert. Its placement is intentional so you can’t miss it.
The FDA dictates the location of a boxed warning in a package insert. It’s right at the top to grab the reader’s attention. It also directs the reader toward important information about the medication.
The black box warning information is enclosed in a box lined by a black border. This is where the term “black box warning” comes from. There are also special requirements to make it stand out from other information in the package insert. For example, the words are all in bold print.
Pharmacies don’t usually give you the original medication package insert. But you may get a medication guide (information sheet) with certain medications that have black box warnings. A medication guide goes over how to use the medication. It also explains potential serious side effects. You can search for medication guides here.
Other resources have black box warning information. You can search the FDA website and the pharmaceutical company’s website for your medication. The Prescribers’ Digital Reference is also available. But mostly healthcare providers use that.
How does the FDA decide which medication gets a black box warning?
Before the FDA approves a medication, it must go through rigorous studies. This is to ensure that it’s safe and effective for its intended use. Ideally, one of those studies will identify any possible serious side effects and risks. In that case, the FDA would apply boxed warnings at the time of approval. But that doesn’t always happen.
The FDA issues most black box warnings after a medication has already hit the market. New and serious side effects may arise once the broader population starts to take it.
The FDA reviews medication safety issues before approval. And they continue to track safety after approval, too. Anyone can report medication side effects through an FDA program called MedWatch. This includes consumers, healthcare providers, and pharmaceutical companies.
MedWatch data is stored in the FDA Adverse Event Reporting System (FAERS). The FDA uses FAERS to track medication side effects and safety issues. It helps them look for patterns and changes in frequency or severity. Upon investigation, they may determine that a specific risk needs a black box warning.
The FDA usually considers one of the following situations before giving a medication a black box warning:
A risk is so serious (e.g., life-threatening) that it needs to be considered when prescribing the medication. This is because the risk may outweigh the potential benefits for certain people.
Serious side effects or risks could be lessened or prevented by appropriate use of the medication. This includes monitoring for certain lab values or avoiding medications that could interact.
Certain restrictions need to be applied to the medication to ensure safe use. This might include special training to prescribe or dispense the medication. Certain populations (e.g., pregnant people) may need to avoid the medication.
What are some common examples of medications with black box warnings?
It may surprise you that over 400 medications have black box warnings. It’s possible that one of the medications you’re currently taking has this type of warning. Specific medications may receive a black box warning. But it’s more common for a whole medication class to receive a black box warning. Let’s review a few examples.
Glitazones
Glitazones are medications commonly used to treat Type 2 diabetes. Examples include Avandia and pioglitazone (Actos).
These medications can cause or worsen heart failure in some people. For this reason, people with symptomatic heart failure should avoid these.
The black box warning recommends monitoring for signs and symptoms of heart failure. This is especially the case after starting the medication or when the dose is raised. Symptoms include fast weight gain, swelling in your limbs (e.g., ankles), and shortness of breath.
Combination birth control pills
People assigned female at birth may take birth control pills that contain estrogen and progestin to prevent pregnancy. Examples include Loestrin FE 1/20 (norethindrone/ethinyl estradiol/ferrous fumarate) and Yaz (drospirenone/ethinyl estradiol).
These medications may raise the risk of blood clot problems, which can cause a heart attack or stroke. This risk is greater if you’re over age 35 and smoke.
For this reason, the black box warning recommends against using these medications in this population.
ACE inhibitors
Angiotensin converting enzyme (ACE) inhibitors are medications that treat high blood pressure and certain heart conditions. Examples include lisinopril (Prinivil, Zestril) and enalapril (Vasotec).
These medications can potentially cause harm to an unborn baby during pregnancy. Because of this, the black box warning advises against using them while pregnant. If you become pregnant while taking an ACE inhibitor — with the help of your healthcare provider — you should immediately stop taking it.
NSAIDS
Nonsteroidal anti-inflammatory drugs (NSAIDs) are medications that treat mild to moderate pain. Examples include naproxen (Aleve, Naprosyn) and ibuprofen (Advil, Motrin). They’re available over the counter (OTC) and by prescription.
NSAIDs may raise the risk of a heart attack or stroke, even early in treatment. People with heart conditions or risks for heart problems have a greater risk. You should avoid NSAIDs in certain cases, like if you’ve recently had a heart attack.
NSAIDs can also raise the risk for serious gastrointestinal (GI) side effects such as ulcers and bleeding. Older adults and people with a history for GI bleeding or ulcers have a greater risk. If you have a higher risk for GI bleeds, you should consider taking a different medication.
The NSAID black box warning recommends using the lowest dose for the shortest amount of time. It also recommends monitoring for symptoms of potential GI issues such as stomach cramps, bloody stool, or vomit. You should also check for heart-related problems like chest pain, shortness of breath, sudden numbness, or weakness.
Antidepressants
Antidepressants are medications that treat depression and other mental health conditions. Examples include selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), and tricyclic antidepressants (TCAs).
Antidepressants may raise the risk of suicidal thoughts and behaviors. Children and young adults (under age 25) are at higher risk.
All antidepressant medications include a black box warning that details this risk. A healthcare provider should monitor anyone taking antidepressants for changes in their behavior and mood. Family members and caregivers should monitor for changes, too. This is especially the case after starting the medication or changing the dose.
What should I do if my medication has a black box warning?
You may be worried if your medication has a black box warning. This is understandable. Since these warnings can be very serious, you may want to stop taking it. Don’t stop or change how you’re taking your medication without talking to your healthcare provider. This can be dangerous.
As we’ve reviewed, there are many medications with black box warnings. Remember: They’re safe when you use them appropriately and take certain precautions.
Discuss any questions about your medication’s black box warning with your healthcare provider. Using the information provided, you can make a decision together that’s most appropriate and safe for you.
The bottom line
It’s important to understand the major risks and side effects of a medication. But a black box warning isn’t a sign that you should stop taking your medication altogether.
A black box warning isn’t meant to completely rule out the use of a medication. Its purpose is to bring attention to important information. When you use it appropriately, a medication with a boxed warning can be a safe and reasonable treatment option.
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References
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National Institute of Diabetes and Digestive and Kidney Diseases. (2016). Symptoms & causes of GI bleeding.
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