Vivitrol Linked to Serious Injection Site Reactions. Vivitrol (generic: naltrexone), a drug used to treat alcohol addiction, has been causing serious injection site reactions, the Food & Drug Administration (FDA) warned today. Among the serious problems linked to are ‘Vivitrol’ are abscesses requiring surgical drainage. Vivitrol is manufactured by Alkermes, Inc., and is marketed by […]
Vivitrol Linked to Serious Injection Site Reactions. Vivitrol (generic: naltrexone), a drug used to treat alcohol addiction, has been causing serious injection site reactions, the Food & Drug Administration (FDA) warned today. Among the serious problems linked to are ‘Vivitrol’ are abscesses requiring surgical drainage.
Vivitrol is manufactured by Alkermes, Inc., and is marketed by Cephalon, Inc. Vivitrol was approved in 2006 for the treatment of alcohol dependence in patients who are able to abstain from alcohol in an outpatient setting prior to initiation of treatment. ‘Vivitrol’ is an extended release medication, and is administered via intramuscular gluteal injection once a month.
According to the FDA, there have been 196 reports of injection site reactions including cellulitis, induration, hematoma, abscess, sterile abscess, and necrosis following ‘Vivitrol’ administration. Sixteen 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.
The FDA said healthcare providers should consider the following information when administering Vivitrol:
The FDA said physicians should advise their patients that administration of ‘Vivitrol’ may be followed by pain, redness, itching, bruising, and swelling. Sometimes reactions at the injection site can quickly worsen and skin and other tissue can be permanently damaged and require surgery. Patients should be told to contact their doctor if an injection site reaction does not improve within two weeks following the injection, or if it worsens sooner than 2 weeks.
The FDA said it is working with the maker of ‘Vivitrol’ to make changes to the prescribing information based on post-marketing adverse event reports of injection site reactions.
The personal injury attorneys at Parker Waichman LLP offer free, no-obligation case evaluations. For more information, fill out our online contact form or call 1-800-YOURLAWYER (1-800-968-7529).