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  • FDA Date: 08/12/2008

    Vivitrol (naltrexone) FDA Drug Safety Communication

    Information for Healthcare Professionals: Naltrexone Injection-Site Reactions (naltrexone for extended-release injectable suspension [marketed as Vivitrol])

    This information reflects FDA's current analysis of data available to FDA concerning this drug. FDA intends to update this sheet when additional information or analyses become available.

    FDA is notifying healthcare professionals of the risk of adverse injection-site reactions in patients receiving naltrexone (Vivitrol). Physicians should instruct patients to monitor the injection site and contact them if they develop pain, swelling, tenderness, induration, bruising, pruritus, or redness at the injection site that does not improve or worsens within two weeks. Physicians should promptly refer patients with worsening injection-site reactions to a surgeon.

    This information reflects the current analysis of data available to FDA concerning this drug. FDA intends to update this communication when additional information or analyses become available.

    View the full FDA Drug Safety Communication on FDA.gov