Allen A. Mitchell, MD

Emeritus Professor, Epidemiology

Allen Mitchell


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.

Other Positions

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


  • Tufts University School of Medicine, MD
  • Washington University in St. Louis, BA


  • Published on 7/11/2023

    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. PMID: 37356083.

    Read at: PubMed
  • Published on 3/2/2022

    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. PMID: 35238183.

    Read at: PubMed
  • Published on 8/3/2021

    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. PMID: 34346174.

    Read at: PubMed
  • Published on 7/23/2021

    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. PMID: 34296811.

    Read at: PubMed
  • Published on 12/1/2020

    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.

    Read at: PubMed
  • Published on 9/2/2020

    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. PMID: 32875745.

    Read at: PubMed
  • Published on 7/4/2020

    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. PMID: 32623767.

    Read at: PubMed
  • Published on 1/5/2020

    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.

    Read at: PubMed
  • Published on 1/1/2020

    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. PMID: 31809437.

    Read at: PubMed
  • Published on 8/21/2019

    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. PMID: 31433116.

    Read at: PubMed

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