Allen A. Mitchell, MD
Emeritus Professor
Boston University School of Public Health

MD, Tufts University
BA, Washington University in St. Louis

Allen A. Mitchell is an Emeritus Professor of Epidemiology Pediatrics at the Boston University Schools of Public Health and Medicine. He is also Director Emeritus of the Slone Epidemiology Center at Boston University, having served as Director from 1998-2015.

Dr. Mitchell obtained his BA degree from Washington University in St. Louis in 1966 and his M.D. from Tufts University School of Medicine in Boston in 1970. After pediatric residency training at the Boston Floating Hospital for Infants and Children (Tufts-New England Medical Center), he joined the Boston Collaborative Drug Surveillance Program where, among other activities, he worked with Drs. Slone, Shapiro, and Heinonen in the analysis of Collaborative Perinatal Project data on birth defects and drugs in pregnancy.

In 1973-75 he was a fellow in pediatric clinical pharmacology at Children's Hospital in Boston (jointly with the Center for the Evaluation of Clinical Procedures at the Harvard School of Public Health), during which time he established the Pediatric Drug Surveillance ("PeDS") Program, an intensive drug surveillance effort focused on the frequency of medication use and adverse effects among hospitalized children. In 1975 he joined Drs. Slone and Shapiro at the newly-created Drug Epidemiology Unit (now Slone Epidemiology Center--SEC) at Boston University, where he continued to direct the PeDS Program.

Following his interest in both pharmacoepidemiology and birth defects, Dr. Mitchell in 1975 applied the concept of case-control surveillance to the study of teratogenesis, and initiated the SEC Birth Defects Study (BDS) which continued uninterrupted data collection until November, 2015. During that time, the BDS collected data on prenatal exposures for over 50,000 malformed infants (and controls) identified at over 90 hospitals and state birth defects registries in the regions surrounding Boston, Philadelphia, Toronto, San Diego, New York State, and Nashville. The BDS was one of two data collection components collaborating with the American Academy of Allergy, Asthma, and Immunology in a national systematic surveillance effort (Vaccines and Medication in Pregnancy Safety Surveillance—“VAMPSS”) designed to evaluate the risks and safety of the wide range of medications taken by pregnant women.

Dr. Mitchell designed and directed a practitioner-based trial of 84,000 children to assess the safety of pediatric ibuprofen, and in the process created a network that continued to conduct clinically-relevant office-based research. He also developed and directed epidemiologic efforts to evaluate pregnancy prevention efforts as part of risk management programs associated with isotretinoin (Accutane and others) and thalidomide (Thalomid), and designed the Slone Survey, a random sample of the U.S. population designed to identify the broad range of medications used in the week prior to interview.

Dr. Mitchell is the author of numerous publications in the fields of pediatric and birth defects pharmacoepidemiology and serves on many editorial boards and advisory committees.

Emeritus Professor
Boston University Chobanian & Avedisian School of Medicine
General Pediatrics

Massachusetts Center for Birth Defects Research and Prevention (BD STEPS) - Core
02/28/2019 - 08/31/2023 (Co-Investigator)
Comm. of Mass./Department of Public Health HHS CDC

Births Defects Study to Evaluate Pregnancy Exposures (BD-STEPS2)
01/14/2019 - 06/30/2020 (Multi-PI)
PI: Allen A. Mitchell, MD
Comm. of Mass./Department of Public Health HHS CDC

Massachusetts Center for Birth Defects Research and Prevention
07/01/2014 - 08/31/2019 (Subcontract PI)
Comm. of Mass./Department of Public Health HHS CDC

Exploring Modifiable Factors for Folic Acid Resistant Spina Bifida
09/01/2015 - 04/30/2019 (Co-Investigator)
PI: Martha Werler, DSc
HHS/CDC/National Center for Birth Defects and Developmental Disabilities
6 U01DD001184-03-03

Analysis of the Association between Infections, Vaccinations, and Medications during Pregnancy and Possible Birth Defects Outcomes, and Creation of an Archived Database
09/23/2016 - 03/22/2019 (PI)
HHS/National Vaccine Program Office

Protocol Development for Pregnancy Surveillance for Mepolizumab (VAMPSS)
01/11/2016 - 01/10/2017 (Subcontract PI)
Educational Research Trust (AAAAI) GlaxoSmithKline, Inc

Postmarking Surveillance of Afluria Influenza Vaccine Safety in Pregnancy
08/01/2013 - 11/30/2015 (PI)
American Academy of Allergy, Asthma, and Immunology

09/30/2009 - 07/31/2015 (PI)
HHS/Agency for Healthcare Research and Quality

Case Control Safety Surveillance Study of Influenza in Pregnant Women and their Infants
07/07/2010 - 07/06/2015 (Subcontract PI)
HHS/PHS (Public Health Contracts) DHHS

Hirschsprung Disease, Birth Defects and Intestinal Motility Disorders
07/01/2014 - 06/30/2015 (Subcontract PI)
The Children's Hospital of Philadelphia Burroughs Wellcome

Showing 10 of 26 results. Show All Results


Yr Title Project-Sub Proj Pubs
2022 BD-STEPS II (Birth Defects Study To Evaluate Pregnancy exposures) - Core (Component A) & Steps Stillbirth (Component B) 5U01DD001224-05
2021 BD-STEPS II (Birth Defects Study To Evaluate Pregnancy exposures) - Core (Component A) & Steps Stillbirth (Component B) 5U01DD001224-04 5
2020 BD-STEPS II (Birth Defects Study To Evaluate Pregnancy exposures) - Core (Component A) & Steps Stillbirth (Component B) 5U01DD001224-03 5
2019 BD-STEPS II (Birth Defects Study To Evaluate Pregnancy exposureS) - Core 5U01DD001224-02 5
2018 BD-STEPS II (Birth Defects Study To Evaluate Pregnancy exposureS) - Core 1U01DD001224-01 5
2018 BD-STEPS II (Birth Defects Study To Evaluate Pregnancy exposureS) - Core 6U01DD001224-01M002 5
2015 Massachusetts Stillbirth Risk Factor Pilot Project 3U01DD001037-03S1 4
2015 Massachusetts Center for Birth Defects Research and Prevention 5U01DD001037-03 4
2014 Massachusetts Center for Birth Defects Research and Prevention 5U01DD001037-02 4
2013 Massachusetts Center for Birth Defects Research and Prevention 1U01DD001037-01 4
Showing 10 of 60 results. Show All Results

Publications listed below are automatically derived from MEDLINE/PubMed and other sources, which might result in incorrect or missing publications. Faculty can login to make corrections and additions.

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  1. Werler MM, Kerr SM, Ailes EC, Reefhuis J, Gilboa SM, Browne ML, Kelley KE, Hernandez-Diaz S, Smith-Webb RS, Garcia MH, Mitchell AA. Patterns of Prescription Medication Use during the First Trimester of Pregnancy in the United States, 1997-2018. Clin Pharmacol Ther. 2023 Oct; 114(4):836-844.View Related Profiles. PMID: 37356083; PMCID: PMC10949220; DOI: 10.1002/cpt.2981;
  2. Kerr S, Heinke D, Yazdy MM, Mitchell AA, Darling AM, Lin A, Nestoridi E, Werler MM. Use of vasoactive medications in pregnancy and the risk of stillbirth among birth defect cases. Birth Defects Res. 2022 May; 114(8):277-294.View Related Profiles. PMID: 35238183; PMCID: PMC9798591; DOI: 10.1002/bdr2.1996;
  3. Esposito DB, Parker SE, Mitchell AA, Tinker SC, Werler MM. Periconceptional nonsteroidal anti-inflammatory drug use, folic acid intake, and the risk of spina bifida. Birth Defects Res. 2021 10 15; 113(17):1257-1266.View Related Profiles. PMID: 34346174; PMCID: PMC10311430; DOI: 10.1002/bdr2.1944;
  4. Howley MM, Werler MM, Fisher SC, Van Zutphen AR, Carmichael SL, Broussard CS, Heinke D, Ailes EC, Pruitt SM, Reefhuis J, Mitchell AA, Browne ML. Maternal exposure to hydroxychloroquine and birth defects. Birth Defects Res. 2021 10 15; 113(17):1245-1256.View Related Profiles. PMID: 34296811; PMCID: PMC8426694; DOI: 10.1002/bdr2.1943;
  5. Anderson KN, Lind JN, Simeone RM, Bobo WV, Mitchell AA, Riehle-Colarusso T, Polen KN, Reefhuis J. Maternal Use of Specific Antidepressant Medications During Early Pregnancy and the Risk of Selected Birth Defects. JAMA Psychiatry. 2020 12 01; 77(12):1246-1255. PMID: 32777011; PMCID: PMC7407327; DOI: 10.1001/jamapsychiatry.2020.2453;
  6. Kerr SM, Parker SE, Mitchell AA, Tinker SC, Werler MM. Folic acid antagonist use before and during pregnancy and risk for selected birth defects. Birth Defects Res. 2020 11; 112(18):1526-1540.View Related Profiles. PMID: 32875745; PMCID: PMC10938459; DOI: 10.1002/bdr2.1789;
  7. Schrager NL, Adrien N, Werler MM, Parker SE, Van Bennekom C, Mitchell AA. Trends in first-trimester nausea and vomiting of pregnancy and use of select treatments: Findings from the National Birth Defects Prevention Study. Paediatr Perinat Epidemiol. 2021 01; 35(1):57-64.View Related Profiles. PMID: 32623767; PMCID: PMC9754706; DOI: 10.1111/ppe.12705;
  8. Kerr SM, Van Bennekom CM, Mitchell AA. Tetanus, diphtheria, and pertussis vaccine (Tdap) in pregnancy and risk of major birth defects in the offspring. Birth Defects Res. 2020 03; 112(5):393-403. PMID: 31903700
  9. Heinke D, Nestoridi E, Hernandez-Diaz S, Williams PL, Rich-Edwards JW, Lin AE, Van Bennekom CM, Mitchell AA, Nembhard WN, Fretts RC, Roberts DJ, Duke CW, Carmichael SL, Yazdy MM. Risk of Stillbirth for Fetuses With Specific Birth Defects. Obstet Gynecol. 2020 01; 135(1):133-140.View Related Profiles. PMID: 31809437; PMCID: PMC7033649; DOI: 10.1097/AOG.0000000000003614;
  10. Petersen JM, Parker SE, Benedum CM, Mitchell AA, Tinker SC, Werler MM. Periconceptional folic acid and risk for neural tube defects among higher risk pregnancies. Birth Defects Res. 2019 11 15; 111(19):1501-1512.View Related Profiles. PMID: 31433116; PMCID: PMC7186568; DOI: 10.1002/bdr2.1579;
Showing 10 of 229 results. Show More

This graph shows the total number of publications by year, by first, middle/unknown, or last author.

Bar chart showing 220 publications over 43 distinct years, with a maximum of 13 publications in 2013


2012 Ntional Birth Defects Prevention Network: Godfrey P. Oakley, Jr., Award for significant contributions to the field of birth defects
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715 Albany St
Boston MA 02118
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