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Editor's Note
March 2017

Regulatory Action Necessary for Immune Globulin Preparations for Hepatitis A Prophylaxis

Author Affiliations
  • 1Los Angeles County Department of Health Services, Los Angeles, California
JAMA Intern Med. 2017;177(3):432-433. doi:10.1001/jamainternmed.2016.9196

Immune globulin is recommended as a method for preexposure and postexposure prophylaxis of hepatitis A (an alternative is the hepatitis A vaccine). Despite having prescribed immune globulin many times, I had never once specified a proprietary name, nor considered the possibility that some of the preparations I might prescribe may not be effective.

The research letter by Tejada-Strop et al1 demonstrates that there is tremendous heterogeneity in the potency of available immune globulin preparations, with only 2 of 9 products currently on the market meeting the minimal potency standard for hepatitis A. Furthermore, even though these products are meant to provide 90 days of protection (important when used for travel), none of the products provided this; 4 of 9 never reached protective levels of anti–hepatitis A immune globulin; 2 maintained protective levels for only 1 day; and the other 3 maintained protective levels for 19, 40, and 53 days, respectively.

The culprit is the decline in hepatitis A exposure in donors. The US Food and Drug Administration needs to take immediate action to change the recommended dose, or change the donor pool of the immune globulin, or change the labeling so that prescribers know which products are likely to be effective under what circumstances. Until there is further regulatory advice, it would be wise to use those preparations with the highest tested potency and duration of protective levels of immune globulin, and to use the hepatitis A vaccine whenever possible for preprophylaxis or postprophylaxis instead of immune globulin.

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Article Information

Corresponding Author: Mitchell H. Katz, MD, Los Angeles County Department of Health Services, 313 N Figueroa St, Rm 912, Los Angeles, CA 90012 (mkatz@dhs.lacounty.gov).

Tejada-Strop  A, Costafreda  MI, Dimitrova  Z, Kaplan  GG, Teo  C-G.  Evaluation of potencies of immune globulin products against hepatitis A  [published online January 9, 2017].  JAMA Intern Med. doi:10.1001/jamainternmed.2016.9057Google Scholar