MedWatch: The FDA Safety Information and Adverse Event Reporting Program

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  • Sterile Compounded Products by US Compounding, Inc: Recall – Lack of Sterility Assurance If the sterility of a compounded preparation intended to be sterile is compromised, patients may be at risk. Posted 09/24/2015
  • Avycaz (ceftazidime and avibactam): Drug Safety Communication – Dose Confusion and Medication Errors FDA revised the labels to indicate that each vial contains Avycaz 2.5 gram, equivalent to ceftazidime 2 gram and avibactam 0.5 gram. Posted 09/22/2015
  • Tramadol: Drug Safety Communication – FDA Evaluating Risks of Using in Children Aged 17 and Younger Ultra-rapid metabolizers are more likely to have higher-than-normal amounts of the active form of the opioid in their blood after taking tramadol, which can result in breathing difficulty that may lead to death. Posted 09/21/2015
  • Freedom Driver System by SynCardia: Class I Recall – Part May Fail Causing Device to Stop Working If the device stops pumping, the patient will lose consciousness almost immediately, which can lead to serious injury or death. Posted 09/18/2015
  • Ayurvedic Dietary Supplements by Shree Baidyanath: Consumer Advice Notice – Products Contain High Levels of Lead and/or Mercury Testing has found that these products contain high levels of lead and/or mercury, which can cause serious health problems. Posted 09/17/2015
  • Reprocessed Flexible Bronchoscopes: FDA Safety Communication – Risk of Infection If scope reprocessing procedure is not followed meticulously, the flexible bronchoscope can remain contaminated, potentially resulting in infection transmission from one patient to the next. Posted 09/17/2015

FDA Approved Safety Information

  • DailyMed (National Library of Medicine)
    Current Drug Prescribing Information. (NOTE: Drugs marked “unapproved” on this site have not been reviewed by FDA for safety and efficacy, and their labeling has not been approved.)
  • Medication Guides
    Paper handouts that come with many prescription medicines. Medication Guides address issues specific to particular drugs and drug classes. They contain FDA-approved information that can help patients avoid serious adverse events.
  • Potential Signals of Serious Risks/New Safety Information Identified from the FDA Adverse Event Reporting System (FAERS)
  • Postmarket Drug and Biologic Safety Evaluations
    Evaluations performed 18 months after drug approval, or after its use by 10,000 individuals.

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