Alcohol Dependence Drug Can Cause Adverse Reactions Warned FDA

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Main Category: Regulatory Affairs / Drug Approvals
Also Included In: Alcohol / Addiction / Illegal Drugs
Article Date: 13 Aug 2008 - 12:00 PDT

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The US Food and Drug Administration (FDA) issued an alert to healthcare professionals on Tuesday advising them of the risk of adverse injection site reactions in patients given injections of Vivitrol (generic name naltrexone), a drug that is used to treat alcohol dependence.

Vivitrol ( naltrexone) is marketed in the US by Cephalon Inc. It was approved in 2006 for treating alcohol dependence in patients in an outpatient setting who are able to abstain from alcohol before starting treatment. The approval was on the condition that the drug be used as "part of a comprehensive management program that includes psychosocial support".

The drug is given as an intramuscular (IM) gluteal injection and "should not be administered intravenously, subcutaneously, or inadvertently into fatty tissue" said the FDA alert, and doctors are advised to make sure they give the injection using only the specifically designed and pre-packaged one and a half-inch needle that comes with the drug.

The FDA said doctors should tell their patients to keep an eye on the site of the injection and report back if they experience any pain, swelling, tenderness, induration (hardening of the tissue around the injection site), bruising, pruritis (itchiness) or redness that gets worse or does not go away within two weeks. Patients whose reactions get worse should be referred to a surgeon immediately.

The agency said they issued the alert because they had received 196 reports of adverse reactions. These included various injection site reactions such as cellulitis (infection of deep tissue), induration, hematoma (internal bleeding), abscess, sterile abscess, and necrosis (dead tissue). 16 of the patients needed surgery; the ones who had abscesses had to have tissue cut open and drained, and others affected by necrosis had to have extensive "debridement" to remove dead tissue.

The FDA asked doctors to report unexpected or serious reactions to the drug via its MedWatch site at http://www.fda.gov/medwatch/report/hcp.htm.

The agency said it is working with the manufacturer to develop stronger and more prominent warnings for the drug.

Click here to rea the full FDA alert.

Sources: FDA.

Written by: Catharine Paddock, PhD
Copyright: Medical News Today
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