Safety Alerts & Recalls

What does this mean?

Although rare, injection site reactions can lead to serious complications if untreated. If you or someone you care for is receiving naltrexone (Vivitrol) injections, monitor the injection site and contact your doctor if pain, swelling, tenderness, bruising, itching, or redness develops at the injection site.

Monitor for Injection Site Reactions

FDA has released an alert to advise about the risks of adverse injection site reactions in patients receiving naltrexone (Vivitrol), the injectable form of the drug used for the treatment of alcohol dependence.

FDA has received several reports of injection site reactions including infection, bruising, swelling, abscesses and sometimes necrosis, a condition of extensive death of skin tissue that often leads to surgery.

Healthcare providers should ensure that the naltrexone injection is given correctly as an intramuscular (IM) injection in the buttocks.

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Source: FDA
Publication Date: 2008-08-12
Last Updated: 2009-12-06

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