PMID- 15717323 OWN - NLM STAT- MEDLINE DCOM- 20060419 LR - 20191210 IS - 1053-8569 (Print) IS - 1053-8569 (Linking) VI - 14 IP - 6 DP - 2005 Jun TI - An overview of adverse events reported by participants in CDC's anthrax vaccine and antimicrobial availability program. PG - 393-401 AB - PURPOSE: The CDC's Anthrax Vaccine and Antibiotic Availability Program was implemented under an Investigational New Drug (IND) application to provide additional post-exposure prophylaxis for individuals potentially exposed to Bacillus anthracis in the fall of 2001. Participants were provided with two options: (1) 40 additional days of antimicrobial prophylaxis (i.e., ciprofloxacin, doxycycline, or amoxicillin); or (2) 40 additional days of antimicrobial prophylaxis plus three doses of anthrax vaccine adsorbed (AVA). METHODS: Participants were monitored for adverse events (AEs). Participants were asked to complete 2-week AE diaries for 6 weeks post-enrollment, and approximately 2 months after enrollment, active surveillance was conducted through telephone interviews with 1113 (64%) participants. RESULTS: A total of 1727 of approximately 10 000 previously prophylaxed persons enrolled to receive 40 additional days of antibiotics. Of these, 199 opted at enrollment to receive three doses of AVA in addition to the additional 40 days of antibiotic. Overall, 28% of participants reported at least one AE on their diaries. Results varied by surveillance mechanism, the diary data indicated differences in the proportion reporting AEs between participants receiving antibiotic only and participants receiving antibiotic and AVA. However, during the active 2-month telephone follow-up, the rates of AEs reported for both the antibiotic only and antibiotic plus AVA treatment regimens were similar. Additionally, ciprofloxacin and doxycycline had similar AE profiles, with only rigors reported significantly more often among ciprofloxacin recipients. CONCLUSIONS: Overall, the rates of AEs experienced by all participants were acceptable given the seriousness of potential B. anthracis exposure. FAU - Martin, Stacey W AU - Martin SW AD - Anthrax Vaccine Safety Team, Epidemiology and Surveillance Division, National Immunization Program, Centers for Disease Control and Prevention, Atlanta, GA 30333, USA. ZMT0@CDC.GOV FAU - Tierney, Bruce C AU - Tierney BC FAU - Aranas, Aaron AU - Aranas A FAU - Rosenstein, Nancy E AU - Rosenstein NE FAU - Franzke, Laura H AU - Franzke LH FAU - Apicella, Louis AU - Apicella L FAU - Marano, Nina AU - Marano N FAU - McNeil, Michael M AU - McNeil MM LA - eng PT - Comparative Study PT - Journal Article PL - England TA - Pharmacoepidemiol Drug Saf JT - Pharmacoepidemiology and drug safety JID - 9208369 RN - 0 (Anthrax Vaccines) RN - 0 (Anti-Bacterial Agents) RN - 5E8K9I0O4U (Ciprofloxacin) RN - 804826J2HU (Amoxicillin) RN - N12000U13O (Doxycycline) SB - IM CIN - Pharmacoepidemiol Drug Saf. 2005 Jun;14(6):389-91. PMID: 15924332 MH - *Adverse Drug Reaction Reporting Systems MH - Amoxicillin/therapeutic use MH - Anthrax/drug therapy/immunology/*prevention & control MH - Anthrax Vaccines/administration & dosage/*adverse effects MH - Anti-Bacterial Agents/*therapeutic use MH - Bacillus anthracis/*drug effects/immunology MH - Bioterrorism/prevention & control MH - Centers for Disease Control and Prevention, U.S. MH - Chemoprevention/adverse effects/methods MH - Ciprofloxacin/therapeutic use MH - Cohort Studies MH - Data Collection MH - Doxycycline/therapeutic use MH - Female MH - Follow-Up Studies MH - Human Experimentation/*statistics & numerical data MH - Humans MH - Male MH - Middle Aged MH - Surveys and Questionnaires MH - Time Factors MH - United States EDAT- 2005/02/18 09:00 MHDA- 2006/04/20 09:00 CRDT- 2005/02/18 09:00 PHST- 2005/02/18 09:00 [pubmed] PHST- 2006/04/20 09:00 [medline] PHST- 2005/02/18 09:00 [entrez] AID - 10.1002/pds.1085 [doi] PST - ppublish SO - Pharmacoepidemiol Drug Saf. 2005 Jun;14(6):393-401. doi: 10.1002/pds.1085.