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MedWatch Safety Alert for Ampyra
The FDA issued a safety announcement for the multiple sclerosis drug, Ampyra (dalfampridine). Seizures are a known side effect of Ampyra, with increased risk associated with higher blood levels of the...
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New Drug Monograph for Sklice
The FDA recently approved the new topical antiparasitic, Sklice (ivermectin topical), for the treatment of head lice in adults and children greater than 6 months old. Learn more at www.epocrates.com
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New Generic Drug Monograph for Montelukast
The FDA recently approved the generic formulation of the leukotriene inhibitor, montelukast (generic for Singulair), for the maintenance treatment of asthma, exercise-induced bronchospasm, and allergic...
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New Indication for Lucentis
The FDA recently approved a new indication for the angiogenesis inhibitor, Lucentis (ranibizumab). In addition to neovascular (wet) age-related macular degeneration (AMD) and macular edema following...
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MedWatch Safety Alert for Codeine
The FDA recently informed health professionals and consumers about reports of serious adverse effects occurring in children taking codeine after tonsillectomy and/or adenoidectomy for obstructive sleep...
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New Drug Monograph for Myrbetriq
The FDA recently approved the oral beta-3 adrenergic agonist, Myrbetriq (mirabegron), to treat symptoms of overactive bladder in adult patients experiencing urinary incontinence, urgency, and urinary...
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New Indication for Aplenzin
The FDA recently approved the antidepressant Aplenzin (bupropion hydrobromide) for seasonal affective disorder in adult patients. Learn more at www.epocrates.com
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MedWatch Safety Alert for Revatio
The FDA recently notified healthcare professionals about the off-label use of Revatio (sildenafil) in the pediatric population. Revatio should not be used to treat pediatric patients with pulmonary...
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MedWatch Safety Alert for Topical Analgesics
The FDA recently issued a warning about the potential risk of serious chemical burns associated with the application of menthol, methyl salicylate, or capsaicin products (alone or in combinations),...
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New Drug Monograph for Qsymia
The FDA recently approved the combination product, Qsymia (phentermine hydrochloride/topiramate), for chronic weight management in adult patients with a body mass index (BMI) of 30 or greater (obese)...
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New Drug Monograph for Stribild
The FDA recently approved the new four-drug combination, Stribild (elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil), given as one tablet daily to treat HIV infection in treatment-naïve adult...
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New Indication for Humira
The FDA recently approved the anti-tumor necrosis factor (TNF) drug, Humira (adalimumab), to induce and maintain remission of ulcerative colitis in adult patients with moderate to severe active disease...
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New Indication for Abraxane
The FDA recently approved the taxane mitosis inhibitor, Abraxane (paclitaxel nanoparticle albumin-bound), to treat locally advanced or metastatic non-small cell lung cancer in adult patients. Learn...
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New Pediatric Indication for Venofer
The FDA recently approved Venofer (iron sucrose), for iron maintenance treatment in pediatric patients greater than 2 years old with iron deficiency anemia associated with chronic kidney disease (CKD)...
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MedWatch Labeling Change for Trilipix
The prescribing information for Trilipix (fenofibric acid) was recently updated to include a new warning about severe paradoxical decreases in HDL cholesterol (HDL-C) levels noted in postmarketing and...
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New Drug Monograph for Synribo
The FDA recently approved the cephalotaxine agent, Synribo (omacetaxine mepesuccinate), to treat chronic myelogenous leukemia in patients with resistance and/or intolerance to at least two tyrosine...
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New Drug Monograph for Flucelvax
The FDA recently approved Flucelvax (influenza vaccine) for the prevention of seasonal influenza in adult patients. Flucelvax is produced using cultured animal cells, rather than fertilized chicken...
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New Indication for Promacta
The FDA recently approved the thrombopoietin receptor agonist, Promacta (eltrombopag), for use in patients with thrombocytopenia associated with chronic hepatitis C and receiving interferon-based...
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MedWatch Safety Alert for Xyrem
The FDA recently reminded healthcare professionals and patients to avoid combining Xyrem (sodium oxybate) with alcohol, insomnia drugs, or other central nervous system depressant drugs due to increased...
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New Drug Monograph for Linzess
The FDA recently approved the oral drug, Linzess (linaclotide), to treat chronic idiopathic constipation and irritable bowel syndrome with constipation in adult patients. Learn more at www.epocrates.com
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