• FDA Calls for Boxed Warning on Combination of Opioid Analgesic and Benzodiazepines.

    USFDA News Release, Drug Safety and Availability.
    06/09/2016

    FDA review recently reported increasing serious side effects caused so far due to combination of two classes of drugs namely: Opioid analgesic and Benzodiazepine. According to FDA, the number of prescriptions for the two classes of drugs increased significantly between 2004 and 2011, with the number of deaths involving both drugs nearly tripling during that time. So, reports say that combination of Opioid & Benzodiazepine has led to growing number of serious problems including extreme sleepiness, respiratory depression, coma and death.

    Opioid are generally prescribed by Physician for pain and cough while, Benzodiazepine are used for treating patients suffering from anxiety, insomnia and seizures.

    Message for Doctors:

    Physician should limit prescribing Opioid analgesic with Benzodiazepine other CNS depressant only to those patients whom alternative treatment options are inadequate.

    Physician should warn Patients about the risks of medications like: extreme sleepiness, respiratory depression and coma.

    Avoid prescribing prescription Opioid cough medicines for patients taking Benzodiazepine or other CNS Depressant including alcohol.

    Changes made by USFDA:

    Changes include the New Box Warning and revision to the warnings & Precautions, Drug Interaction and Patient Counselling in the information sections of labeling.

    Categories: Blog for Doctors, CME & Education, Doctors Daily

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