FDA MedWatch

Vivitrol (naltrexone)- Serious Injection Site Reactions May Occur

08/12/2008- FDA informed healthcare professionals of the risk of adverse injection site reactions in patients receiving naltrexone. Naltrexone is indicated for the treatment of alcohol dependence in patients who are able to abstain from alcohol in an outpatient setting prior to initiation of treatment. Naltrexone is administered as an intramuscular gluteal injection and should not be administered intravenously, subcutaneously, or inadvertently into fatty tissue. 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. Read the FDA recommendations for healthcare professionals to consider regarding the use of Naltrexone injection.

Read the entire MedWatch Safety Summary, including a link to the FDA Drug Information Page regarding this issue at:
http://www.fda.gov/medwatch/safety/2008/safety08.htm#naltrexone