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Update: Adverse Events Associated with Anthrax Prophylaxis AmongPostal Employees --- New Jersey, New York City, and the District ofColumbia Metropolitan Area, 2001

Antimicrobial prophylaxis to prevent inhalational anthrax has beenrecommended for persons potentially exposed to Bacillusanthracis as a result of the recent bioterrorist attacks(1). During October 26--November 6, 2001, anepidemiologic evaluation to detect adverse events associated with antimicrobial prophylaxiswas conducted among 8,424 postal employees who had been offeredantimicrobial prophylaxis for 60 days in New Jersey (NJ), New York City (NYC), and onepostal facility in the District of Columbia (DC). This report summarizes preliminary resultsof that evaluation, which found that few employees receiving antimicrobialprophylaxis sought medical attention for symptoms that may have been associatedwith anaphylaxis. Persons with exposures to B. anthracisrelated to the bioterrorist attacks should complete the full 60-day course of antimicrobial prophylaxis.

In NJ, NYC, and DC, a questionnaire was administered on days 7 to 10 afterpostal employees received prophylaxis (when they returned for medication refills). InNYC and DC, the questionnaire was self-administered by postal employees; in NJ,nurses interviewed postal workers and administered the questionnaire. Informationwas collected about the type of antimicrobial used, the occurrence of adverseevents, medical attention sought for adverse events related to antimicrobial prophylaxis,and discontinuation of prophylaxis. Persons who reported hospitalization or soughtmedical attention for symptoms that may have been associated with anaphylaxis (i.e.,difficulty breathing; throat tightness and difficulty swallowing; swelling of lips, tongue, orface; and rash, hives, and itchy skin) are being followed up closely by contactingpatients and clinicians to confirm or exclude possible hospitalizations andlife-threatening adverse events.

Of the 8,424 postal employees offered antimicrobial prophylaxis, 5,819(69%)completed or were administered the questionnaire to evaluate the occurrenceof adverse events. A total of 3,863 (66%) had initiated antimicrobial prophylaxis*;of these, 3,428 (89%) reported using ciprofloxacin for antimicrobial prophylaxis;435 (11%) used other antimicrobials (when ciprofloxacin was contraindicated),including doxycycline (6%) and amoxicillin (1%) (Table 1). Of the 3,428 persons onciprofloxacin, 666 (19%) reported severe nausea, vomiting, diarrhea, or abdominal pain; 484(14%) reported fainting, light-headedness, or dizziness; 250 (7%) reported heartburn oracid reflux; and 216 (6%) reported rashes, hives, or itchy skin. Of those personstaking ciprofloxacin, 287 (8%) discontinued the medication; 116 (3%) discontinuedthe medication because of adverse events, 27 (1%) discontinued because of fearof possible adverse events, and 28 (1%) stopped taking the drug because they "didnot think it was needed." For the 3,863 persons on any medication forantimicrobial prophylaxis, 83 (2%) sought medical attention for symptoms that may havebeen associated with anaphylaxis. Among the 33 persons who sought medical attentionfor these symptoms in NJ and NYC, none was hospitalized and none of the symptomswas attributed to antimicrobial prophylaxis by clinicians who evaluated thesepersons. Follow-up of persons in DC who sought medical attention for symptoms that mayhave been associated with anaphylaxis is ongoing.

Reported by: R Brechner, MD, State Epidemiologist, Maryland Dept of Health and Hygiene.G DiFerdinando, MD, E Bresnitz, MD, State Epidemiologist, New Jersey Dept of Healthand Senior Svcs. New York City Dept of Health; SH Factor, MD, TD Matte, MD, Center forUrban Epidemiologic Studies, New York Academy of Medicine, New York. L Siegel, MD, S Adams,I Walks, MD, J Davies-Coles, PhD, M Richardson, MD, District of Columbia Dept of Health.E Peterson, MD, R Stroube, MD, State Epidemiologist, Virginia Dept of Health. NationalCenter for Infectious Diseases; and EIS officers, CDC.

Editorial Note:

Among persons with exposures toB. anthracis related to the recent bioterrorist attacks, completion of a full 60-day course of antimicrobial prophylaxisis essential for preventing anthrax (1). Activities to promote adherence amongpostal employees in NJ, NYC, and DC include messages (e.g., posters at the worksite)to promote adherence, small group discussions with postal employees to identifyand resolve barriers to adherence, and reminder devices (e.g., pocket calendars).In addition, a key component of promoting adherence is monitoring adverse eventsthat might deter patients from taking antimicrobial prophylaxis. Information fromthese monitoring systems can be used to reassure workers of antimicrobial prophylaxisand to guide management of workers with potentially serious adverse events.

Although adverse events were commonly reported by postal employeeswho participated in this evaluation and included gastrointestinal anddermatologic reactions, only 2% of persons surveyed sought medical care for symptoms thatmay have been associated with anaphylaxis. Overall rates of adverse events (regardlessof attributability) in NJ, NYC, and DC are similar to the frequency of adverseevents among other persons on antimicrobial prophylaxis for exposures toB. anthracis related to these bioterrorist attacks(2) and among persons on ciprofloxacintherapy for any indication (3,4). The higher rates of adverse events in NJ compared withNYC and DC (p=0.001), may be explained by the different mode of administration ofthe questionnaires (nurse versus self-administered). Discontinuation of therapy causedby adverse events was similar to other groups previously studied(5). Both active and passive monitoring of adverse events and promotion and assessment of adherenceto prophylaxis will continue for the duration of the recommendedpostexposureprophylaxis.

References

1. CDC. Update: investigation of anthrax associated with intentional exposure andinterim public health guidelines, October 2001. MMWR 2001;50:889--93.
2. CDC. Update: investigation of bioterrorist-related anthrax and adverse eventsfrom antimicrobial prophylaxis. MMWR 2001;50:973--6.
3. Segev S, Yaniv I, Haverstock D, Reinhart M. Safety of long-term therapywith ciprofloxacin: data of controlled clinical trials and review. Clin Infect Dis 1999;28:229--308.
4. Food and Drug Administration. Medical review. Available at<http://www.fda.gov/cder/foi/nda/2000/19-537S038_cipro.htm>. Accessed November 2001.
5. Halkin H. Adverse effects of the fluoroquinolones. Rev Infect Dis 1988;10(suppl1):S258--S261.

* The proportion of surveyed postal employees who had initiated prophylaxis variedacross sites: 1,643 (99%) in DC, 434 (99%) in NJ, and 1,786 (48%) in NY. In NY,antimicrobial prophylaxis was recommended for approximately 1,800 postal employees who wereat increased risk for anthrax and made available to another 2,600 postal employees atlower risk for anthrax.

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Source: Centers for Disease Control and Prevention.