US FDA warns of injection-site reactions with naltrexone
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US FDA warns of injection-site reactions with naltrexone The US FDA has issued an Alert to notify healthcare professionals of the risk of injection-site reactions associated with naltrexone [Vivitrol]. The agency advises that it has received 196 such reports, which include necrosis, cellulitis, abscess, sterile abscess, induration and haematoma; 16 patients required surgical intervention. The FDA says that naltrexone should only be administered as an IM gluteal injection, and given correctly with the specifically designed prepackaged needle. The agency recommends that physicians instruct patients to monitor their injection site and contact their physician should they develop reactions that do not improve, or worsen, within 2 weeks. Patients with worsening injection-site reactions should be promptly referred to a surgeon. FDA. Naltrexone injection site reactions (naltrexone for extended-release injectable suspension (marketed as Vivitrol). Internet Document : [3 pages], 12 Aug 2008. 801075345 Available from: URL: http://www.fda.gov
0114-9954/10/1216-0001/$14.95 Adis © 2010 Springer International Publishing AG. All rights reserved
Reactions 23 Aug 2008 No. 1216
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