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Author: Admin | 2025-04-28
A boxed warning is the sternest warning issued by the U.S. Food and Drug Administration (FDA) that a medication can carry and still remain on the market in the United States. A boxed warning appears on the label of a prescription medication to alert you and your healthcare provider about any important safety concerns, such as serious adverse effects or life-threatening risks. UpperCut Images/Getty Images A boxed warning, also known as a “black label warning” or “black box warning,” is named for the black border surrounding the text of the warning that appears on the package insert, label, and other literature describing the medication (for example, magazine advertising). When the FDA Requires One The FDA requires a boxed warning for one of the following situations: The medication can cause serious undesirable effects (such as a fatal, life-threatening or permanently disabling adverse reaction) compared with the potential benefit from the drug. Depending on your health condition, you and your physician would need to decide whether the potential benefit of taking the drug is worth the risk.A serious adverse reaction can be prevented, reduced in frequency, or reduced in severity by proper use of the drug. For example, a medication may be safe to use in adults, but not in children. Or, the drug may be safe to use in adult women who are not pregnant. Information Required The FDA requires the boxed warning to provide a concise summary of the adverse effects and risks associated with taking the medication. You and your physician need to be aware of this information when deciding to start the drug or if you should switch to another medication altogether. Understanding adverse effects will help you make a better-informed decision. Warning Examples The following are examples of boxed warnings that have been required for some commonly used medications: Fluoroquinolone Antibiotics According to the FDA, people taking a fluoroquinolone antibiotic have an increased risk of tendinitis and tendon rupture, a serious injury that could cause permanent disability. The FDA warning includes Cipro (ciprofloxacin), Levaquin (levofloxacin), Avelox (moxifloxacin) and other medications containing fluoroquinolone. (Warning issued July 2018.) Antidepressant Medications According to the FDA, all antidepressant medications have an increased risk of suicidal thinking and behavior, known as suicidality, in young adults aged 18 to 24 during initial treatment (generally the first one to two months). The FDA warning includes Zoloft (sertraline), Paxil (paroxetine), Lexapro (escitalopram), and other antidepressant medication. (Warning issued May 2007.) What Does One Look Like? The following excerpt from the prescription label of Zoloft is an example of a boxed warning. Suicidality in Children and AdolescentsAntidepressants increased the risk of suicidal thinking and behavior (suicidality) in short-term studies in children and adolescents with Major Depressive
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