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...
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Hydrocodone/paracetamol (section Boxed warning)
product." In the US, the label for hydrocodone/paracetamol contains a boxed warning about addiction, abuse, and misuse. Hydrocodone: Respiratory depression...
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Enoxaparin sodium (section Boxed warning)
Hyperkalemia Transaminitis Hemorrhage The FDA issued a revision to the boxed warning for enoxaparin in October 2013. The revision recommends exercising caution...
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montelukast. In March 2020, the FDA required a boxed warning for montelukast to strengthen an existing warning about the risk of neuropsychiatric events associated...
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Liothyronine (section Boxed warning)
cycle sensitivity to heat The package insert contains the following boxed warning, as do all thyroid hormones: Drugs with thyroid hormone activity, alone...
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benzodiazepines, barbiturates, or antiepileptic drugs The FDA has issued a boxed warning regarding an increased risk for suicidal thoughts and behavior in children...
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cases of acute renal failure and death and has added the following boxed warning to the products' label: "Repeated use of meloxicam in cats has been...
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label must prominently display the symbol "Rx" and a red-boxed warning "Schedule H drug. Warning : "Not to be sold by Retail without the prescription of...
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September 2020, the US Food and Drug Administration (FDA) required that boxed warnings for all benzodiazepine medications be updated to describe the risks...
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sertraline, to carry a boxed warning stating that antidepressants increase the risk of suicide in persons younger than 25 years. This warning is based on statistical...
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Brentuximab vedotin (section Black box warning)
Apothekerzeitung (in German) (10/2013): 68. "FDA Drug Safety Communication: New Boxed Warning and Contraindication for Adcetris (brentuximab vedotin)". U.S. Food...
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availability and thus effectiveness, wherefore patiromer has received a boxed warning by the US Food and Drug Administration (FDA), telling patients to wait...
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Tigecycline (section Black box warning)
death with IV antibacterial Tygacil (tigecycline) and approves new Boxed Warning". U.S. Food and Drug Administration (FDA). 27 September 2013. Retrieved...
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are contraindicated in those who are infected.[citation needed] The boxed warning for the drug rituximab (Rituxan) includes a statement that Human polyomavirus...
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September 2020, the U.S. Food and Drug Administration (FDA) required the boxed warning be updated for all benzodiazepine medicines to describe the risks of...
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Boxed may refer to: Boxed.com, a wholesale on-line shopping site. Boxed (Eurythmics), an eight album box set Boxed (Mike Oldfield album) Boxed warning...
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taking the medication. The US FDA label for semaglutide contains a boxed warning for thyroid C-cell tumors in rodents. It is unknown whether semaglutide...
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nasopharyngitis (the "common cold"). Tofacitinib is required by the FDA to have a boxed warning on its label about possible injury and death due to problems such as...
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(sold under the brand name Celebrex) and traditional NSAIDs received boxed warnings on their labels. Many COX-2–specific inhibitors have been removed from...
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September 2020, the U.S. Food and Drug Administration (FDA) required the boxed warning be updated for all benzodiazepine medicines to describe the risks of...
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insufficient by state courts. In September 2009, the FDA required a boxed warning be put on promethazine for injection, stating the contraindication for...
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observed. In 2010, the US Food and Drug Administration (FDA) added a boxed warning, later updated, to Plavix, alerting that the drug can be less effective...
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States in 2020. The FDA label for idecabtagene vicleucel carries a boxed warning for cytokine release syndrome (CRS), neurologic toxicity, hemophagocytic...
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born with birth defects. In 1985 the label was updated to include a boxed warning. In early 1988 the FDA called for another advisory committee, and FDA...
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in the regulation of T cell-dependent immune response. "US FDA adds 'boxed warning' for Amgen's bone loss drug Prolia". Reuters, January 19, 2024. Boyce...
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Quinolone antibiotic (section Boxed warnings)
sometimes serious adverse effects occur. In 2008, the U.S. FDA added black box warnings on all fluoroquinolones, advising of the increased risk of tendon damage...
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September 2020, the US Food and Drug Administration (FDA) required the boxed warning for all benzodiazepine medicines to be updated to describe the risks...
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Other adverse events occurred at rates of <1%. Ciprofloxacin includes a boxed warning in the United States due to an increased risk of tendinitis and tendon...
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doi:10.1542/peds.2005-2664. PMID 16882832. S2CID 21568481. "FDA requires boxed warning and risk mitigation strategy for metoclopramide-containing drugs" (Press...
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the restrictions it had placed on the drug. The boxed warning about heart attack was removed; the warning about heart failure remained in place. GSK was...
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