Oral and Long-Acting Injectable Naltrexone: Removal of Boxed Warning for Hepatotoxicity

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Oral and Long-Acting Injectable Naltrexone: Removal of Boxed Warning for Hepatotoxicity

To the Editor: The recent commentary “Acamprosate, Alcoholism, and Abstinence”1 by Barbara J. Mason provides an excellent overview of the Sunrise Study by Higuchi for the Japanese Acamprosate Study Group.2 However, Mason incorrectly states that naltrexone has a “black box” warning for hepatotoxicity. For both oral naltrexone3 and long-acting injectable naltrexone,4 the prescribing information was revised in 2013. It should be noted that, although the boxed warning was removed, there is still a warning and precaution related to hepatotoxicity in the full prescribing information of both oral and extended-release naltrexone.3,4 As mentioned in the commentary, it is important to utilize safe, well-tolerated, and effective medications for substance use disorders, and therefore it is important that the current prescribing information for both formulations of naltrexone is correctly communicated to ensure that the treating community has the most current information available for the limited number of approved treatment options for this patient population.

References

1. Mason BJ. Acamprosate, alcoholism, and abstinence. J Clin Psychiatry. 2015;76(2):e224-e225. PubMed doi:10.4088/JCP.14com09632

2. Higuchi S; Japanese Acamprosate Study Group. Efficacy of acamprosate for the treatment of alcohol dependence long after recovery from withdrawal syndrome: a randomized, double-blind, placebo-controlled study conducted in Japan (Sunrise Study). J Clin Psychiatry. 2015;76(2):181-188. PubMed doi:10.4088/JCP.13m08940

3. Revia [package insert]. Pomona, NY: Duramed Pharmaceuticals, Inc; 2013.

4. Vivitrol [package insert]. Waltham, MA: Alkermes, Inc; 2013.

Jeffrey Stoddard, MDa

[email protected]

Jacqueline Zummo, MPH, MBAa

aMedical Affairs, Alkermes, Inc, Waltham, Massachusetts

J Clin Psychiatry 2015;76(12):1695

dx.doi.org/10.4088/JCP.15lr09974

© Copyright 2015 Physicians Postgraduate Press, Inc.