If a drug carries a serious risk of injury or death, the U.S. Food and Drug Administration (FDA) may require the manufacturer to include a boxed warning or black box warning, named for the prominent black border surrounding it. Black box warnings are the highest safety-related warning issued by the FDA. They advise patients, healthcare practitioners, and general consumers of potential health risks associated with the drug.
Currently, over 400 drugs contain a black box warning. Many times, the FDA issues a black box warning for a group of medications instead of a single drug. A drug or medical device may have a black box warning issued or taken away at any time while on the market. In some instances, black box warnings are issued after multiple adverse reports are received through the FDA’s MedWatch program.
In this article, readers will learn what a black box warning is and why they are issued. They will also find out what to do if they have been harmed by a drug with a black box warning.
What Is a Black Box Warning?
A black box warning is the highest-safety warning issued by the FDA. Named for the prominent black border surrounding the warning, it is frequently issued when the drug or medical device may cause a significant risk of injury or death.
The advisories, which are designed to capture attention, may also indicate instructions for the safe use of the drug or device, warn of serious side effects, and note any interactions with other medications. Drug labels may contain three types of advisories, including warnings and precautions, contraindications, and boxed warnings.
Understanding a drug or medication label:
- Warnings and Precautions: Most drug labels include a list of precautions, which may include information on how certain groups may be affected by the medication, such as those pregnant or breastfeeding. The precautions section may also include information on conditions that may affect the drug’s effectiveness and potential side effects.
- Contraindications: A contraindication is listed on a drug label when the risk of harm outweighs the therapeutic benefit of the medication because of a particular condition. A common contraindication is if someone is allergic to the drug or an ingredient in the drug.
- Boxed warnings: Boxed warnings are the most serious safety warning issued by the FDA. They are required in cases where there is risk of a serious adverse reaction, such as severe injury or death, or when the only safe distribution of the drug is restricted.
What Does a Black Box Warning Look Like
Due to the risk of severe harm, boxed warnings must be prominently displayed on the drug’s label. According to the FDA, to be in compliance with § 201.57(d) of the Code of Federal Regulations, the BOXED WARNING section cannot exceed 20 lines in length. It must be contained within a box in bold print and in a format that makes the information “visually accessible,” including with the use of bullet points or subheadings. Finally, it must contain the following statement after the heading: “See full prescribing information for complete boxed warning.”
Common Symptoms and Side Effects Found in Black Box Warnings
Black box warnings are issued when there is a risk of severe adverse effects from the drug or medical device. Severe adverse effects may include if there is a risk of a life-threatening event, long-term injury, significant incapacity, congenital anomaly, birth defect, inpatient hospitalization, or death.
Potential advisories highlighted in black box warnings, include risk of:
- Heart attack or stroke
- Liver damage
- Suicidal thoughts or behaviors
- Blood clots
- Death
- Tendonitis or tendon rupture
- Dementia or Alzheimer’s
- Respiratory issues
- Addiction
- Vision loss
- Gastrointestinal issues
- Cancer
Medications Commonly Carrying Black Box Warnings
Some of the most popular drugs on the market contain black box warnings designed to inform patients and healthcare practitioners about the risk of harm associated with use. Individuals should discuss any potential adverse reactions with their healthcare provider.
Black box warnings are found on a range of medications commonly prescribed in the U.S., including:
- Antidepressants (SSRIs and SNRIs): Increased risk of suicidal thoughts and behaviors, particularly in children and young adults.
- Antipsychotics: Elderly patients with dementia-related psychosis are at an increased risk of death, primarily from cardiovascular issues or infections when taking Risperdal, Invega, Zyprexa, or certain other medications.
- Nonsteroidal anti-inflammatory drugs (NSAIDs): Risk of cardiovascular events such as heart attack or stroke.
- Certain antibiotics and fluoroquinolones: Potential for tendon rupture or irreversible nerve damage.
- Immunosuppressants: Higher risk of infection and certain cancers due to decreased immune response.
- Chemotherapy drugs: Severe toxicity or organ damage in high doses.
The FDA’s Role in Black Box Warnings
The US Food and Drug Administration has a multi-step review process to determine the safety of prescription and over-the-counter medications. Prior to approval, drugs go through pre-approval trials. These trials include preclinical testing on animals and clinical trials on humans. Once pre-approval trials have been completed, a manufacturer can file a New Drug Application, which effectively seeks FDA approval.
Once the drug makes it to market, the FDA still collects post-market data, including adverse event reports. The Office of Surveillance and Epidemiology (OSE) monitors and evaluates a drug’s safety profile throughout its life cycle. If a concerning level of adverse event reports is received or information leads the FDA to believe that the drug may be unsafe, the regulator may require a boxed warning to be added to the label. A black box warning is designed to draw attention to severe harm that may result from the use of the medication.
While the FDA promotes its collaboration with drug manufacturers as engaging stakeholders, it can lead to problems with transparency and even delayed warnings. When a manufacturer knows or should have known about the risk of harm associated with the use of its drug and fails to warn patients, it may lead to litigation.
How Black Box Drug Warnings Are Decided
Black box warnings are reserved for the most serious safety concerns. They are generally required when the adverse event may cause permanent or a life-threatening risk of harm.
Stages of FDA approval for a drug:
- Pre-clinical testing
- Clinical trials
- Application for approval (manufacturer submission)
- FDA evaluation
- Labeling negotiations and FDA approval
- Post-market research
- Issuance of boxed warning (if needed)
How Black Box Warnings Affect Prescribers and Patients
When a black box warning is issued for a drug, prescribers have a duty to disclose and explain the advisories to their patients. Unfortunately, prescribers aren’t always informed of the true risk of harm of a medication, leading to the potential for harm to a patient. In some instances, this is the result of a lack of communication from the manufacturer. If a manufacturer fails to adequately warn prescribers (or patients) about the risk of harm associated with the use of their drug, it may lead to litigation.
For patients, inadequate safety information can cause confusion and increase the potential for harm. Patients must be well-informed about any known risks associated with the medications they are taking. When a manufacturer fails to disclose these risks, it can have serious adverse effects and may lead to legal action.
How to Check for Black Box Warnings
Black box warnings are designed to draw attention in order to ensure patients and prescribers are well-informed of the risk of harm. Patients taking a drug should consult with their prescriber about any boxed warnings issued with the drug, and can find the information through the FDA’s Drug Database or through third-party platforms like DailyMed. Patients may also consult the pharmacist inserts when filling a prescription or the manufacturer’s website.
In some instances, a boxed warning may be issued after a drug has been on the market for some time. Any updates or new warnings should be discussed with the prescriber to determine whether the risk outweighs the therapeutic benefit of taking the drug.
The Role of Black Box Warnings in Mass Tort Litigation
Black box warnings can play a critical role in mass tort litigation involving dangerous drugs. Attorneys representing patients injured by these drugs can use labeling history and correspondence between the FDA and the drug manufacturer to prove that the drug company failed to timely warn consumers about the risk of harm.
It is important to note that the presence of a boxed warning does not automatically shield a company from liability, particularly if the warning was delayed or is incomplete. When a company is required to issue a new or updated warning, it may be an indicator for future litigation. Manufacturers may be held liable if they failed to warn consumers about the risk of harm associated with the use of the drug or engaged in deceptive marketing by claiming that the drug was safer than clinical testing or adverse reporting indicated.
What to Do If You’ve Been Harmed by a Drug with a Black Box Warning
Individuals who have been harmed by a drug with a delayed black box warning are encouraged to seek legal counsel. Depending on the circumstances of the case, a patient harmed by a dangerous drug may be eligible for compensation.
Steps to take if a drug with a black box warning has harmed you:
- Consult with a healthcare provider about the risks of continuing to take a drug with a black box warning,
- Preserve prescription information,
- Gather a copy of all medical records related to adverse health effects from the drug, and
- Consult with a drug-injury lawyer.
The attorneys with Wisner Baum have extensive experience helping individuals who have been injured by a drug with a boxed warning. They have represented thousands of clients who have suffered unimaginable harm, always fighting to secure justice and hold drug companies accountable for their wrongdoing.
Contact a Wisner Baum Prescription Drug Lawyer
Individuals affected by a prescription drug with a boxed warning are encouraged to call Wisner Baum at (310) 207-3233 to schedule a free, no-obligation consultation. Attorneys with Wisner Baum have secured billions on behalf of clients nationwide and will work tirelessly to ensure justice is served.
Black Box Warnings Frequently Asked Questions (FAQs)
Q: How serious is a black box warning?
Black box warnings are the most serious safety warnings issued by the FDA. Boxed warnings should be reviewed with a prescriber to ensure the medication is safe to use based on individual circumstances.
Q: How do you check if your medication has a black box warning?
Black box warnings are required to be prominent and attention-grabbing. Patients can check a manufacturer’s website for safety information or it can be found through the FDA’s drug database. A pharmacist insert will also detail information about any safety alerts associated with the drug.
Q: What drugs carry a black box warning?
Many popular drugs contain a black box warning, including medications like Ozempic. Boxed warnings are often issued for a group of drugs, instead of a specific medication.
Q: Does ibuprofen have a black box?
Ibuprofen is an NSAID. NSAIDs have a boxed warning related to an increased risk of heart attack and stroke.
Q: Do all drugs have black box warnings?
While hundreds of medications have black box warnings, some do not. Black box warnings are reserved for drugs with a severe risk of harm.
Q: Can a drug's black box warning be removed?
A drug’s black box warning may be removed by the FDA if evidence is received that indicates that the risk of harm is less than previously thought.
Q: What are common side effects in black box warnings?
Common side effects in black box warnings include an increased risk of heart attack or stroke, suicidal thoughts or behaviors, liver damage, and cancer.
Q: What percentage of drugs have black box warnings?
Hundreds of drugs contain black box warnings, highlighting the safety concerns associated with both over-the-counter and prescription medications.
Q: Can an over the counter drug have a black box warnings?
Both over-the-counter and prescription drugs can have black box warnings. NSAIDs, such as Ibuprofen, contain a boxed warning due to their increased risk of heart attack and stroke.
Q: Are black box warnings and boxed warnings the same thing?
Black box warnings and boxed warnings refer to the same thing. Boxed warning is the newer term for the serious safety warning issued by the FDA.
Q: Are contraindications the same as a black box warning?
Contraindications are different from black box warnings, although both may appear on a drug label. Black box warnings are the most serious safety warnings issued by the FDA. They are required when a drug has a severe risk of harm. Contraindications inform physicians (and patients) of instances when to avoid prescribing or taking the medication altogether due to the risk of serious adverse events (e.g., warning physicians that patients with certain pre-existing conditions should not be prescribed the drug; or instructing physicians to not prescribe the drug in combination with other drugs when the combination of the two drugs can result in serious adverse events to the patient).
Q: What if I suffer harm from a drug with a black box warning?
Individuals who suffer harm from a drug with a tardily issued black box warning may be eligible to file a lawsuit against the manufacturer or distributor. Affected individuals are encouraged to consult with an attorney to determine eligibility.
