Vivitrol injection site reaction

October 31, 2008

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FDA is alerting healthcare professionals about the risk of serious reactions at the injection site among patients treated with Vivitrol (naltrexone). Vivitrol is administered intramuscularly to treat alcohol dependence.

FDA has received nearly 200 reports of injection site reactions, including cellulitis, induration, hematoma, abscess, sterile abscess and necrosis. Some patients needed surgical intervention. The risk may be increased if the drug is injected subcutaneously or accidentally into fatty tissue.

Practitioners using Vivitrol should use only the specially designed needle that comes with the drug, and take care not to inject the material intravenously, subcutaneously, or into fatty tissue. The special needle may not be long enough to reach muscle tissue in patients with significant gluteal fat. Healthcare providers should consider alternative treatment in these cases.

Patients who develop pain, swelling, bruising, itching or redness that does not improve within two weeks should be instructed to report this, and should be referred to a surgeon.

Click here for the FDA report.

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