A black box warning is the strictest warning the FDA gives to medications, so you know the risks and what precautions you should take before taking specific medications.

You’ve just returned from the pharmacy with a new medication prescribed by your doctor. You open the package to read over the information when you see a black box label at the top of the page, with bold text reading “WARNING” and detailing the serious side effects of the medication you’re about to take. 

But what is a black box warning on medication, and do you need to be concerned about taking this new medication?

What Does Black Box Warning Mean?

An FDA black box warning, also called a boxed warning, is the strictest warning the FDA gives to medications. They are intended to provide clear and easily recognizable warnings about your medication’s potential serious side effects. 

While this doesn’t necessarily mean that the medication is unsafe to take, it is your right to understand the potential harm medications may cause.

You’re not the only one who sees the black box warning label. Both your medical provider and pharmacist review the boxed warning before prescribing and filling your medication. These warnings are present to ensure your healthcare providers are aware of the potential dangers associated with the medication.

A black box warning does not guarantee that you will experience the serious side effects that it lists. They only provide information about the potential risks involved. These side effects typically only occur in a small percentage of people — or when certain instructions aren’t followed. If the medication provides a substantial benefit, it might be worth taking despite the small extra risk.

Which Drugs Have an FDA Black Box Warning?

Over 400 different drugs regulated by the FDA include a black box warning. Even the three most commonly prescribed drugs in the United States — lisinopril, levothyroxine and atorvastatin — include black box warnings. 

The fact that so many drugs contain black box warnings shouldn’t be a need for concern. Oftentimes, the boxed warning only applies in specific circumstances. When the FDA mandates a black box warning for medications, they will include the specific circumstances in which these medications can cause harm and inform you of any potential danger.

5 Common Black Box Warnings for Drugs

A black box warning describes the potential risks of the medication you’ve been prescribed. Oftentimes, these apply to broad drug classes rather than specific drugs. 

What drugs have a black box warning? These are five of the most common black box warnings for drugs and what you should be aware of before taking these medications.

Opioids — Increases Risk of Life-Threatening Respiratory Depression

All opioids include a black box warning for increasing the risk of life-threatening respiratory depression. Put simply, opioids slow your breathing rate, and respiration can stop altogether if opioids are taken in large doses or mixed with other medications. Drugs in this class include:

These drugs should not be combined with other central nervous system depressants, such as alcohol or benzodiazepines, without first talking to your physician.

Antiarrhythmic — Increases Risk of Heart Block

Antiarrhythmic medications are a group of drugs that can treat irregular or too fast heart rhythms. They include medications such as amiodarone, propafenone or flecainide. 

Some of these medications can increase the risk of heart block — a condition where electrical signals sent to the heart are delayed or completely stopped, which can result in side effects such as dizziness, shortness of breath or heart palpitations. Severe cases of heart block may be life-threatening.

Antimalarials — Increases Risk of Neuropsychiatric Effects 

Certain antimalarial drugs, such as mefloquine hydrochloride, have black box warnings about the risk of several neuropsychiatric effects that can persist for long periods or become permanent. 

Some neuropsychiatric symptoms that have been seen in people taking mefloquine hydrochloride include:

  • Anxiety
  • Dizziness
  • Hallucinations
  • Loss of balance
  • Paranoia

This medication should not be taken by people with serious mental health conditions or those who have a history of seizures.

Sodium Blockers — Causes Life-Threatening Skin Reactions

Sodium channel blockers, such as carbamazepine or lamotrigine, have been associated with the development of severe life-threatening skin reactions. People taking these medications are at risk of developing Stevens-Johnson syndrome, toxic epidermal necrolysis, or DRESS syndrome, some of which can be fatal. 

If you notice any skin reactions when taking these medications, you should call your prescriber immediately.

Antipsychotics — Increased Risk of Mortality in Older Patients 

Antipsychotic drugs can help people who are experiencing persistent hallucinations or delusions but can come with serious risks — especially for older patients. Drugs such as quetiapine, risperidone and haloperidol have been associated with an increased risk of mortality in older patients who are experiencing psychosis as a result of dementia.

What To Do if You’re Prescribed a Black Box Medication

Just because a medication has a black box label doesn’t mean it isn’t safe to use. Some of the most commonly prescribed medications in the United States have black box warnings, and most people can still take these medications as prescribed without experiencing any negative side effects.

If you have concerns about the warnings listed in the boxed warning, there are two people you can speak to about your concerns: your prescribing physician and your pharmacist. Make sure to be honest about any pre-existing conditions, cigarette smoking, medications you’re currently taking or specific drug allergies that may affect how you react to your new medication. In the case of opioids, make sure to mention any pre-existing history of addiction in yourself or your immediate family members. 

Listen carefully to their instructions. Things that may seem harmless, such as drinking grapefruit juice or taking over-the-counter (OTC) medications, may affect your risk of experiencing the side effects listed in a black box warning.

When you’re prescribed a new medication, you should ask your doctor about any potential side effects and what to expect. When picking up the medication from the pharmacy, your pharmacist will be available to further discuss any specific instructions or risks associated with the medication and be able to answer any further questions you have. 

Both of these medical professionals are trained to understand the risks associated with your medication and make sure you’re aware of the potential side effects and what to do if you experience them.

Get Help for Co-Occurring Disorders

Using drugs such as alcohol or opioids can often increase the likelihood of experiencing serious side effects listed in a black box warning. Yet, it can be difficult for people with a substance use disorder to stop drinking or remain substance-free on their own. 

Further, many medications that treat co-occurring mental health conditions contain warnings not to mix the medication with alcohol or illicit substances, as it can increase the risk of life-threatening side effects.

If you’re one of the millions of people struggling with addiction and a co-occurring disorder, reach out to the professionals at The Recovery Village at Palmer Lake to learn more about how treatment for co-occurring disorders can help you achieve recovery. 

Our team understands the trials and challenges of struggling with both substance use and mental health conditions, and we have the tools and resources needed to help. At our facility, you can treat both your addiction and mental health condition simultaneously and finally reach recovery and a better quality of life. Don’t delay any longer – reach out to The Recovery Village today.

Melissa-Carmona-1
Editor – Melissa Carmona
As the content manager at Advanced Recovery Systems, Melissa Carmona puts years of writing and editing experience to work helping people understand substance abuse, addiction and mental health disorders. Read more
Cambria
Medically Reviewed By – Elizabeth Cambria PharmD
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Food and Drug Administration. “FDA Drug Safety Communication: FDA warns of serious slowing of the heart rate when antiarrhythmic drug amiodarone is used with hepatitis C treatments containing sofosbuvir (Harvoni) or Sovaldi in combination with another Direct Acting Antiviral drug.”“>“FDA D[…]iral drug.” March 24, 2015. Accessed August 4, 2022.

Food and Drug Administration. “FDA Drug Safety Communication: Important Safety Label Changes to Cholesterol-Lowering Statin Drugs.“>FDA Drug[…]Statin Drugs.” February 28, 2012. Accessed August 4, 2022.

Food and Drug Administration. “FDA requires strong warnings for opioid analgesics, prescription opioid cough products, and benzodiazepine labeling related to serious risks and death from combined use.”“>“FDA r[…]bined use.” August 31, 2016. Accessed August 4, 2022.

Fuentes, Andrea V.; et al. “Comprehension of Top 200 Prescribed Drugs in the US as a Resource for Pharmacy Teaching, Training and Practice.”“>“Compr[…] Practice.” Pharmacy: Journal of Pharmacy Education and Practice, May 2018. Accessed August 4, 2022.

John Hopkins Medicine. “Heart Block“>Heart Block.” August 8, 2021. Accessed August 4, 2022.

Meeks, Thomas W.; Jeste, Dilip V. “Beyond the Black Box: What Is The Role for Antipsychotics in Dementia?“>Beyond t[…] in Dementia?” Current Psychiatry, June 1, 2008. Accessed August 4, 2022.

 

Medical Disclaimer

The Recovery Village at Palmer Lake aims to improve the quality of life for people struggling with substance use or mental health disorder with fact-based content about the nature of behavioral health conditions, treatment options and their related outcomes. We publish material that is researched, cited, edited and reviewed by licensed medical professionals. The information we provide is not intended to be a substitute for professional medical advice, diagnosis or treatment. It should not be used in place of the advice of your physician or other qualified healthcare providers.