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Title: FDA Issues Warning for Naltrexone Injection Site Reactions
URL: http://www.pslgroup.com/dg/22836E.htm
Doctor's Guide
August 12, 2008

ROCKVILLE, Maryland -- August 12, 2008 -- The US Food and Drug Administration (FDA) issued a notification to healthcare professionals of the risk of adverse injection site reactions in patients receiving naltrexone (Vivitrol). According to the FDA, physicians should instruct patients to monitor the injection site and contact them if pain, swelling, tenderness, induration, bruising, pruritus, or redness develops at the injection site that does not improve or worsens within 2 weeks. Physicians should promptly refer patients with worsening injection site reactions to a surgeon.

The FDA received reports of 196 patients who suffered injection site reactions including cellulitis, induration, hematoma, abscess, sterile abscess, and necrosis. Of those reported, 16 patients required surgical intervention ranging from incision and drainage in the cases of abscesses to extensive surgical debridement in the cases that resulted in tissue necrosis.

Naltrexone is indicated for the treatment of alcohol dependence in patients who can abstain from alcohol in an outpatient setting prior to initiation of treatment. Naltrexone is administered as an intramuscular gluteal injection. Naltrexone should not be administered intravenously, subcutaneously, or inadvertently into fatty tissue. Healthcare providers should ensure that the naltrexone injection is given correctly with the prepackaged 1.5-inch needle that is specifically designed for this drug.


SOURCE: US Food and Drug Administration

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