Tag: Fda black box warning

According to the FDA, PROCRIT (epoetin alfa) and other erythropoiesis-stimulating agents (ESAs) carry a black box warning due to the risk of serious side effects. This means that anyone taking this medication, which helps treat anemia, should be fully aware of the potential for both common and severe health issues.

In 2019, the U.S. Food and Drug Administration (FDA) issued a black box warning for zolpidem, highlighting the risk of serious injuries and fatalities from complex sleep behaviors. This action underscores the profound safety concerns surrounding this common insomnia treatment and explains why is zolpidem a high risk medication, despite its widespread use.

Studies reveal that antipsychotics, including risperidone and haloperidol, carry a significant black box warning for increased mortality risk in elderly patients with dementia-related psychosis. When considering pharmacological interventions for behavioral and psychological symptoms of dementia (BPSD), the critical question of 'Is risperidone or haloperidol better for dementia in the elderly?' requires a careful evaluation of risks versus benefits, efficacy, and safety profile.

The U.S. Food and Drug Administration (FDA) has issued a boxed warning for promethazine due to the potential for fatal respiratory depression in pediatric patients under two years of age, a primary reason doctors no longer prescribe promethazine as a first-line treatment. The medication's significant risks and widespread availability of safer alternatives have prompted a major shift in prescribing habits.

Following a 2001 U.S. Food and Drug Administration (FDA) boxed warning, the use of droperidol became highly restricted due to concerns about QT interval prolongation and a potentially fatal heart arrhythmia called Torsades de Pointes (TdP). This led to the establishment of a specific QTc cutoff for droperidol, which remains a critical safety measure for healthcare providers today.

The FDA has issued multiple serious, or 'boxed', warnings for rituximab due to significant adverse event reports. The most important safety information includes risks of fatal infusion reactions, progressive multifocal leukoencephalopathy (PML), and hepatitis B virus (HBV) reactivation.

According to the FDA, women using Depo-Provera Contraceptive Injection may lose significant bone mineral density, a risk that increases with the duration of use and may not be fully reversible. This article explores what does Depo do to your bones, and what patients and healthcare providers need to know to make informed decisions.