Vivitrol Causes Adverse Injection Site Reactions

The FDA notified doctors that Vivitrol has been shown to cause adverse injection site reactions. Vivitrol, also known as naltrexone, was approved by the FDA in April 2006, to be used as one component of a comprehensive alcoholism treatment program. There have been 196 various injection site reactions reported to the FDA. Such reactions include cellulitis, abscess, necrotic abscess, fat necrosis, and necrotic hematoma. Some patients required surgery to treat their wounds. Administration of Vivitrol is done via intramuscular injection in alternating buttocks, using a specially designed needle which is included with the drug. Physicians should not use any other needle to administer Vivitrol, and should not give the drug intravenously or in fatty tissue. Some symptoms of an adverse reaction include pain, swelling, bruising, pruritus and redness at the injection site. Such a condition can potentially lead to permanent tissue damage, and if the symptoms do not improve within two weeks, the patient should be referred to a surgeon. Stronger and more prominent warnings about these risks may be added to the prescribing information for Vivitrol.