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Information on pharmaceutical drugs, side effects and labelling

Asmanex HFA (mometasone furoate)

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) July 2016 USE IN SPECIFIC POPULATIONS PLLR Conversion: Pregnancy Risk Summary There are no randomized clinical studies…

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Alinia (nitazoxanide)

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) July 2016 PLR Conversion; please refer to label. ADVERSE REACTIONS (updated) Clinical Trials Experience Because clinical…

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Yondelis (trabectedin)

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) July 2016 WARNINGS AND PRECAUTIONS Hepatotoxicity Assess LFTs prior to each administration of YONDELIS and as clinically…

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Thallous Chloride T1201 Injection

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) July 2016 WARNINGS AND PRECAUTIONS Risk of Extravasation and Tissue Damage (and Tissue Damage added) Addition of:  Confirm…

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Dysport (abobotulinumtoxinA)

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) July 2016 ADVERSE REACTIONS The following serious adverse reactions are discussed below and elsewhere in labeling: (additions) …

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Jardiance (empagliflozin)

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) July 2016 WARNINGS AND PRECAUTIONS Ketoacidosis (addition of the following sentence) Fatal cases of ketoacidosis have been…

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Glyxambi (empagliflozin and linagliptin)

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) July 2016 WARNINGS AND PRECAUTIONS Ketoacidosis (addition of the following sentence in first paragraph) Fatal cases listed

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Flovent Diskus (fluticasone propionate inhalation powder)

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) July 2016 ADVERSE REACTIONS Postmarketing Experience Infections and Infestations: Esophageal candidiasis.  

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Amikacin Sulfate Injection USP 500 mg/2 mL (250 mg/mL) and 1 Gram/4 mL (250 mg/mL) Vials by Teva: Recall – Glass Particulate Matter

Audience: Pharmacy, Nursing ISSUE: Teva Pharmaceuticals announced a voluntary recall of seven lots of Amikacin Sulfate Injection USP, 500 mg/2mL (250 mg/mL) and 1 gram/4mL (250 mg/mL) vials due to the potential for the presence of glass particulate…

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