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In the United States, a boxed warning (sometimes " black box warning ", colloquially) is a type of warning that appears near the beginning of the package insert for certain prescription drugs, so called because the U.S. Food and Drug Administration specifies that it is formatted with a 'box' or border around the text [1] to emphasize it is of ...
- Overview
- What is a boxed warning?
- Which drugs have boxed warnings?
- Talking with a doctor
- Summary
A boxed warning is the most serious warning by the Food and Drug Administration (FDA). Its purpose is to alert people about drug effects that may be dangerous.
Boxed warnings apply to certain medications that carry serious risks for the person taking them. The FDA decides which medications require boxed warnings.
A doctor must review the risks and benefits of a medication with a boxed warning before prescribing it. They will decide whether a medication is safe to prescribe based on a person’s health conditions, any medications they take, and other important factors.
This article will discuss boxed warnings, the types of medications that have boxed warnings, and how to discuss risks with a doctor.
The FDA requires that medications undergo rigorous testing before it allows them to enter the market for prescription use. This is because safety is a priority for any new drug.
The general drug development process is as follows:
•laboratory research
•preclinical research, including animal testing and basic safety tests
•clinical research, also known as human trials
•review, in which the FDA decides whether to approve the new drug
According to 2022 research, over 400 medications currently carry boxed warnings.
The FDA assigns boxed warnings to products that carry risks of death or serious injury. Different drugs can cause these outcomes in different ways. Because of this, a person taking a medication that has a boxed warning should talk with a doctor about any side effects they experience.
Before starting a new medication, it is important for a person to talk with a doctor about how the medication may affect them.
Some medications can cause others to have a different effect than expected. For example, they may make the medication work less effectively in the body or increase the risk of side effects.
For example, the antidepressant sertraline (Zoloft) affects serotonin production in the brain. If a person takes another medication that affects serotonin, the two can interact, leading to a serious condition known as serotonin syndrome.
If a person has a certain medical condition, taking a medication that affects that system or part of the body can cause severe side effects. Clonazepam (Klonopin) treats panic disorder and seizures. If a person takes it with an opioid, they risk severe drowsiness, slowed breathing, coma, and death.
A boxed warning is a serious warning from the FDA. Products assigned a boxed warning carry risks of severe harm or death. Medications that have boxed warnings can be effective treatment options in some cases, but there are potential complications to consider before starting treatment.
A doctor will evaluate the risks and benefits of a medication with a boxed warning before prescribing it. If a person has any concerns or questions about starting a new medication, it is important to discuss them with a healthcare professional.
Boxed warnings (also known as black box warnings) are the strictest warning that can be issued for a drug by the Food and Drug Administration (FDA). First implemented in 1979, they are there to alert doctors to a potentially serious side effect of a medicine or to restrictions on the use of a medicine. The warning or restriction must be ...
Oct 20, 2005 · In an article analyzing all drugs with a “black box” warning in the 1995 PDR, Beach et al 1 found 206 drugs with a “black box” warning, and these warnings could be grouped into categories. Overall, the most frequent warning (n = 95) was for the identification of and avoidance of use in high-risk patients (eg, cigarette smokers and use of oral contraceptives).
- Shirley Murphy, Rosemary Roberts
- 2006
Jun 17, 2023 · Boxed warnings (formerly known as Black Box Warnings) are the highest safety-related warnings that medications can have assigned by the Food and Drug Administration. These warnings are intended to bring the consumer’s attention to the major risks of the drug. Medications can have a boxed warning added, taken away, or updated throughout their tenure on the market. Over 400 different ...
- Claire Delong, Charles V. Preuss
- 2023/06/17
- 2021
Oct 30, 2014 · In 2004, the FDA issued a black-box warning linking antidepressants to an increased risk of suicidal thinking, feeling, and behavior in young people. But some worrisome trends suggest that the warn...
People also ask
What is a boxed or black box warning?
Why is there a “black box” warning on a drug label?
When can a boxed warning be applied to a drug?
Did the FDA issue a black-box warning?
Do antidepressants have a black-box warning?
Why do medications have boxed warnings?
Jun 7, 2007 · The new black-box warning is clearly an attempt to balance the small risk posed by antidepressants against their well-documented benefits. But this new label has the potential to confuse both ...
