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 […]
<"https://www.yourlawyer.com/practice_areas/defective_drugs">Vivitrol (generic: naltrexone), a drug used to treat alcohol addiction, has been causing serious injection site reactions, the <"https://www.yourlawyer.com/practice_areas/defective_drugs">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.