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  • FDA MedWatch: Fluoroquinolone Antibacterial Drugs for Systemic Use - Warnings Updated Due to Disabling Side Effects

    Tuesday, July 26, 2016

    FDA approved changes to the labels of fluoroquinolone antibacterial drugs for systemic use (i.e., taken by mouth or by injection). These medicines are associated with disabling and potentially permanent side effects of the tendons, muscles, joints, nerves, and central nervous system that can occur together in the same patient. As a result, FDA revised the Boxed Warning, FDA’s strongest warning, to address these serious safety issues. In addition, FDA updated other parts of the drug label including the Warnings and Precautions and Medication Guide sections.

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  • FDA MedWatch: Recall - Oral Liquid Docusate Sodium

    Saturday, July 16, 2016

    The FDA is alerting healthcare professionals that PharmaTech LLC, Davie, Florida, is voluntarily recalling all non-expired lots of Diocto Liquid, a docusate sodium solution distributed by Rugby Laboratories, Livonia, Michigan. The agency confirmed the product has been contaminated with Burkholderia cepacia, a bacteria linked to an outbreak in five states. 

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  • FDA MedWatch: July 2016 Safety Labeling Changes

    Thursday, July 14, 2016

    The summary view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections.

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  • FDA MedWatch: INRatio and INRatio2 PT/INR Monitor System by Alere: Recall

    Tuesday, July 12, 2016

    Alere Inc. will be initiating a voluntary withdrawal of the Alere INRatio and INRatio2 PT/INR Monitoring System.

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