During March-April 1996, a physician in the Denver area administered intra muscular injections of a preparation labeled "adrenal cortex injection" to 69 patients in Colorado as part of a weight-loss regimen. As of August 7, a total of 47 (68%) of these persons were reported to have developed abscesses (diameters ranging from 0.5 cm to 4.0 cm) at the site of injection (either gluteal or deltoid muscle). An investigation of these episodes by the physician and the Colorado Department of Public Health and Environment identified Mycobacterium abscessus as the cause of the infections. This report summarizes preliminary findings of the ongoing investigation, which indicate that injection-site abscesses were associated with contaminated injectable preparations.

The 47 case-patients ranged in age from 20 to 63 years (median: 40 years); 46 were female. The interval from injection to presentation for medical care ranged from 10 to 114 days (median: 33 days). Seventeen persons (36%) required one or more incision and drainage procedures; two persons required subcutaneous excision.

In addition to these 47 cases, the physician reported five similar cases among patients he had treated who resided in Wyoming; these patients developed abscesses during August 1995-May 1996 following injection of the preparation. In July 1996, a second physician in the Denver area also reported two cases (one culture-confirmed) of M. abscessus infection following administration of the preparation in September 1995.

Specimens of abscess material were obtained from 11 Colorado patients: culture-confirmed M. abscessus was isolated from one culture, rapid-growing Mycobacterium consistent with M. abscessus was isolated from three cultures, and results are pending for the other cultures. In addition, rapid-growing Mycobacterium consistent with M. abscessus was isolated from one unopened and three opened vials of purported adrenal cortex extract. The vials were labeled "distributed by Hallmark Labs, Inc.," and did not have lot numbers or expiration dates. The label stated the product could be administered intramuscularly, intravenously, or subcutaneously. This product has not been approved by the Food and Drug Administration (FDA).

As a result of these and other episodes, CDC, FDA, and several state health departments are collaborating on a comprehensive investigation of this product.

Reported by: L Miller, MD, E Mangione, MD, J Beebe, PhD, RE Hoffman, MD, State Epidemiologist, Colorado Dept of Public Health and Environment; P Levy, PhD, G Huitt, MD, National Jewish Center for Immunology and Respiratory Medicine, Denver. GL Miller, DVM, State Epidemiologist, Wyoming Dept of Health. Food and Drug Administration. Tuberculosis/ Mycobacteriology Br, Div of AIDS, STD, and TB Laboratory Research; Special Pathogens Section, Childhood and Respiratory Diseases Br, Div of Bacterial and Mycotic Diseases, National Center for Infectious Diseases, CDC.

Editorial Note

Editorial Note: M. abscessus (formerly M. chelonae subspecies abscessus) is an acid-fast rod classified with M. fortuitum and M. chelonae as pathogenic "rapid growing" nontuberculous mycobacteria. Although these organisms are ubiquitous in the environment and have been found in municipal and well water, soil, and dust, they rarely cause disease in humans. M. abscessus has been associated with a variety of infections including skin and soft-tissue infections (following puncture wounds or inoculations), pulmonary infection, infections related to foreign material (e.g., porcine and prosthetic cardiac grafts, prosthetic joints, intravenous and dialysis catheters, tympanoplasty tubes, and augmentation mammoplasty), and postsurgical infections (e.g., sternal wound) (1). Bacteremia and disseminated infection, although rare, occur most commonly in immunocompromised hosts and result in high proportions of deaths (2).

Diagnosis of M. abscessus infection relies on culture and identification of the organism. Rapid-growing mycobacteria grow in common laboratory broths (e.g., Mueller-Hinton and tryptic soy broth) in 5-8 days without supplementation (1). However, more abundant growth occurs on broth and on agar-based media specific for the growth of mycobacteria. Isolates can be mistaken for "diphtheroids" unless acid-fast staining or further identification is performed. Species identification and susceptibility testing should be conducted in a reference laboratory. Treatment of M. abscessus infection involves removal of infected tissue or prosthetic material and antimicrobial therapy. Most isolates of M. abscessus are susceptible to clarithromycin, amikacin, and cefoxitin and demonstrate variable susceptibility to erythromycin (3,4). Combination chemotherapy with at least two antimicrobial agents to which the isolate is susceptible is advised because monotherapy has been shown to contribute to the development of resistance (5). Localized disease usually responds to 2-4 months of therapy in immunocompetent hosts, and disseminated infections can require greater than 6 months of therapy (5).

This report illustrates the risks associated with use by patients and health-care providers of non-FDA approved products or products from unknown sources. Preliminary information suggests the product is distributed primarily to alternative-medicine providers. Adrenal cortex injections reportedly are used to enhance well-being in persons infected with human immunodeficiency virus. To identify infections secondary to injection of purported adrenal cortex extract, health-care providers should inquire about potential previous use in their patients who have cutaneous abscess and should obtain specimens for inoculation on culture media that will support the growth of M. abscessus. Cases of abscess following injection of purported adrenal cortex extract should be reported to local and state health departments.

References

1. Wallace RJ, Swenson JM, Silcox VA, Good RC, Tschen JA, Stone MS. Spectrum of disease due to rapidly growing mycobacteria. Rev Infect Dis 1983;5:657-79.

2. Ingram CW, Tanner DC, Durack DT, Kernodle GW, Corey GR. Disseminated infection with rapidly growing mycobacteria. Clin Infect Dis 1993;16:463-71.

3. Swenson JM, Wallace RJ, Silcox VA, Thornsberry C. Antimicrobial susceptibility of five subgroups of Mycobacterium fortuitum and Mycobacterium chelonae. Antimicrob Agents Chemother 1985;28:807-11.

4. Brown BA, Wallace RJ, Onyi GO, De Rosas V, Wallace RJ III. Activities of four macrolides, including clarithromycin, against Mycobacterium fortuitum, Mycobacterium chelonae, and M. chelonae-like organisms. Antimicrob Agents Chemother 1992;36:180-4.

5. Wallace RJ, Swenson JM, Silcox VA, Bullen MG. Treatment of nonpulmonary infections due to Mycobacterium fortuitum and Mycobacterium chelonei on the basis of in vitro susceptibilities. J Infect Dis 1985;152:500-14.

   
   

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