Off-label drug use is defined as the use of pharmaceutical drug for an unapproved indication, or an unapproved age group, dosage or route of administration.In pediatrics, off-label prescribing is common due to the lack of specific therapeutic options and limited clinical trials in children.In oncology, off-label drugs provide alternatives when approved options are exhausted, with common medications including carboplatin and targeted therapies like Bevacizumab.The older population often experiences off-label use of antipsychotics, antidepressants, anticonvulsants, and anti-VEGF drugs for conditions such as dementia, insomnia, and macular edema.In weight management, limited FDA-approved drugs for obesity lead to off-label prescriptions, including phentermine, metformin, and topiramate.The COVID-19 pandemic has seen the off-label use of drugs like hydroxychloroquine, remdesivir, ivermectin, dexamethasone, and tocilizumab, with evolving evidence and debates on their effectiveness.Drawbacks of off-label drug use include potential safety concerns, lack of established dosing guidelines, limited efficacy data, and the risk of adverse reactions, emphasizing the need for cautious application etc.
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Kushwaha et al. (2024) studied this question.
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