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July 2016

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  • Fluoroquinolone Antibacterial Drugs for Systemic Use: Drug Safety Communication – Warnings Updated Due to Disabling Side Effects

    Wednesday, July 27, 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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  • Zika Update: New FDA Recommendations

    Wednesday, July 27, 2016

    In consideration of the possibility of local Zika virus transmission, FDA has issued new donor screening recommendations for blood collection centers in Broward County, Florida and Miami-Dade County, Florida.

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  • Oral Liquid Docusate Sodium by PharmaTech: Recall – Contaminated with B. Cepacia

    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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  • INRatio and INRatio2 PT/INR Monitor System by Alere: Recall – Potentially Inaccurate INR Results

    Thursday, July 14, 2016

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

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  • Over-the-Counter Antacid Products Containing Aspirin: FDA Drug Safety Communication – Serious Bleeding Risk

    Thursday, July 14, 2016

    The FDA is warning consumers about the risk of serious bleeding when using nonprescription, also known as over-the-counter or OTC, aspirin-containing antacid products to treat heartburn, sour stomach, acid indigestion, or upset stomach. Many other products for these conditions are available that do not contain aspirin.

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  • UNOS/OPTN Zika Bulletin

    Tuesday, July 12, 2016

    UNOS/OPTN has issued a bulletin covering Guidance for Organ Donation and Transplantation Professionals Regarding the Zika Virus including notation about transfusion. Much information remains unknown, and the Guidance revolves around recent donor travel history and risk considerations, with the warning that vulnerability to Zika may also mean vulnerability to Dengue and Chikungunya.

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