Tag: Black box warning

Up to 90% of individuals with dementia experience behavioral and psychological symptoms (BPSD), including psychosis [1.5.3, 1.5.6]. This raises the question: **Can Abilify be used for dementia patients** to manage these challenging symptoms, despite the risks?

Over half of all patients on selective serotonin reuptake inhibitors (SSRIs) like Lexapro report sexual side effects, including low libido and difficulty with orgasm. This common issue is just one aspect of what constitutes the dark side of Lexapro, revealing that its effects extend beyond simply regulating mood.

In 2001, the FDA issued a black box warning for droperidol due to its potential for causing QT prolongation and serious, sometimes fatal, arrhythmias. Therefore, specific patient populations and those with certain risk factors should not take droperidol, and its use is restricted to cases where other treatments are ineffective.

In 2001, the U.S. Food and Drug Administration (FDA) issued a black box warning for droperidol, citing concerns over a potential heart arrhythmia, which sparked a significant and ongoing debate in the medical community. The long-trusted drug, known for its effectiveness as an antiemetic and sedative, virtually disappeared from hospital formularies overnight following the warning.

In December 2001, the U.S. Food and Drug Administration (FDA) mandated a **black box warning on droperidol** due to reported risks of serious cardiac arrhythmias, including torsades de pointes. This significant regulatory action dramatically curtailed the use of droperidol, a potent antiemetic and sedative that was once a staple in many clinical settings. The warning prompted extensive debate within the medical community and led to revised guidelines for patient screening and monitoring.

For over two decades, all estrogen-containing medications prescribed for menopausal women have carried a U.S. Food and Drug Administration (FDA) **black box warning on estradiol** and other estrogens. This warning, originating from a pivotal 2002 study, cautions about potential risks associated with systemic hormone therapy, though its broad application to all estrogen products has become a significant source of controversy.

According to the U.S. Food and Drug Administration (FDA), Humira (adalimumab) carries two prominent "boxed warnings" for serious risks, including life-threatening infections and malignancies. This directly addresses whether Is Humira a high risk medication? and highlights the crucial need for a thorough discussion of its risks and benefits with a healthcare provider.

The Food and Drug Administration (FDA) mandates that medications with potentially life-threatening side effects display a black box warning, the most serious warning it can issue. A prominent black box warning on Brixadi highlights the significant risk of serious harm or death if the subcutaneous injection is administered intravenously instead.

In 2005, the FDA required a black box warning for promethazine due to the potential for fatal respiratory depression in children under two years old. This warning, along with others concerning severe tissue damage and dangerous drug interactions, highlights why **promethazine is a high risk medication** that requires careful prescribing and administration. The medication, while effective for certain conditions like nausea and allergic reactions, carries significant dangers that healthcare professionals and patients must be aware of.

In 2009, the FDA mandated its strongest warning—a black box warning—for metoclopramide (Reglan) due to the risk of tardive dyskinesia [1.3.1]. This article explores the critical question: Why don't doctors prescribe Reglan as a first-choice medication despite its effectiveness for certain conditions?