Abscesses due to mycobacterium abscessus linked to injection of unapproved alternative medication.

Karin Galil,Bob England,Mitchell A Yakrus,Lisa A Miller,David G Mosley,Gwen Huitt,Richard J Wallace,Bradley A Perkins,Michael M Mcneil

doi:10.3201/eid0505.990509

Abstract

An unlicensed injectable medicine sold as adrenal cortex extract (ACE*) and distributed in the alternative medicine community led to the largest outbreak of Mycobacterium abscessus infections reported in the United States. Records from the implicated distributor from January 1, 1995, to August 18, 1996, were used to identify purchasers; purchasers and public health alerts were used to identify patients. Purchasers and patients were interviewed, and available medical records were reviewed. Vials of ACE* were tested for mycobacterial contamination, and the product was recalled by the U.S. Food and Drug Administration. ACE* had been distributed to 148 purchasers in 30 states; 87 persons with postinjection abscesses attributable to the product were identified. Patient and vial cultures contained M. abscessus identical by enzymatic and molecular typing methods. Unusual infectious agents and alternative health practices should be considered in the diagnosis of infections that do not respond to routine treatment.

Highlights

An unlicensed injectable medicine sold as adrenal cortex extract (ACE*) and distributed in the alternative medicine community led to the largest outbreak of Mycobacterium abscessus infections reported in the United States
We report on a multistate outbreak of postinjection abscesses associated with the use of an injectable product purported to contain adrenal cortex extract (ACE)
Wide distribution of an unlicensed injectable preparation contaminated with M. abscessus led to a multistate outbreak of soft-tissue abscesses

Summary

Introduction

An unlicensed injectable medicine sold as adrenal cortex extract (ACE*) and distributed in the alternative medicine community led to the largest outbreak of Mycobacterium abscessus infections reported in the United States. We report on a multistate outbreak of postinjection abscesses associated with the use of an injectable product purported to contain adrenal cortex extract (ACE). ACE never received U.S Food and Drug Administration (FDA) approval, it remains in use by alternative medicine practitioners for such conditions as alcohol and drug withdrawal, allergies, inflammation, and stress management, as well as hypoglycemia and depression attributed to a state of hypoadrenalism [3,4]. The Mycobacterium abscessus outbreak was detected after two Denver-area physicians reported soft-tissue abscesses in patients who received injections of a product purported to contain ACE. Research distribution and purchasers of ACE*; the conditions treated with ACE*; and the occurrences of abscesses as well as the treatment and clinical course of affected patients

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Conclusion