Allen A. Mitchell, M.D.

Allen MitchellDirector
Slone Epidemiology Center

Professor of Epidemiology and Pediatrics
Boston University Schools of Public Health and Medicine

Lecturer on Pediatrics
Harvard Medical School


B.A., 1967, Washington University
M.D., 1970, Tufts University School of Medicine

Research Interests:

Allen A. Mitchell is Professor of Epidemiology and Professor of Pediatrics at the Boston University Schools of Public Health and Medicine. He obtained his B.A. 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) 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 Slone Birth Defects Study (BDS) which continues to this time, having collected data on prenatal exposures from tens of thousands of malformed infants (and controls) identified via birth defects registries in Massachusetts and New York State and at participating hospitals in the regions surrounding Philadelphia, Toronto, San Diego, and Nashville. The BDS is now 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 also designed and directed a practitioner-based “large simple” randomized trial of 84,000 children to assess the safety of pediatric ibuprofen; that practitioner (SCOR) network continues to conduct clinically-relevant office-based research. He also designed and directed epidemiologic studies 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. 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.

Recent Publications

The following are Dr. Mitchell’s 25 most recent publications:

  • Yazdy MM, Mitchell AA, Louik C, Werler MM. Recalling biases: the authors respond [letter to the editor]. Epidemiology (in press). PMCID: PMC Journal – In Process.
  • Louik C, Kerr S, Kelley KE, Mitchell AA. Increasing use of ADHD medications in pregnancy [letter to the editor]. Pharmacoepidemiol Drug Saf 2015;24(2):218-20. doi: 10.1002/pds.3742. PMCID: PMC4313616.
  • Werler MM, Yazdy MM, Kasser JR, Mahan ST, Meyer RE, Anderka M, Druschel CM, Mitchell AA. Maternal cigarette, alcohol, and coffee consumption in relation to risk of clubfoot. Paediatr Perinat Epidemiol 2015;29(1):3-10. doi: 10.1111/ppe.12163. PMCID: PMC Journal – In Process.
  • van Gelder MM, Van Bennekom CM, Louik C, Werler MM, Roeleveld N, Mitchell AA. Maternal hypertensive disorders, antihypertensive medication use, and the risk of birth defects: a case-control study. Br J Obstet Gynaecol 2015. doi: 10.1111/1471-0528.13138 (epub ahead of print).
  • Ahrens KA, Louik C, Kerr S, Mitchell AA, Werler MM. Seasonal influenza vaccination during pregnancy and the risks of preterm delivery and small-for-gestational age birth. Paediatr Perinat Epidemiol 2014;28(6):498-509. doi: 10.1111/ppe.12152. PMCID: PMC Journal – In Process.
  • Yazdy MM, Mitchell AA, Louik C, Werler MM. Use of selective serotonin-reuptake inhibitors during pregnancy and the risk of clubfoot. Epidemiology 2014;25(6):859-65. doi: 10.1097/EDE.0000000000000157. PMCID: PMC4180776.
  • Yazdy MM, Mitchell AA, Werler MM. Maternal genitourinary infections and the risk of gastroschisis [editor’s choice]. Am J Epidemiol 2014;180(5):518-25. doi: 10.1093/aje/kwu157. PMCID: PMC4143079.
  • Louik C, Kerr S, Mitchell AA. First-trimester exposure to bupropion and risk of cardiac malformations. Pharmacoepidemiol Drug Saf 2014;23(10):1066-75. doi: 10.1002/pds.3661.
  • Werler MM, Yazdy MM, Kasser JR, Mahan ST, Meyer RE, Anderka M, Druschel CM, Mitchell AA. Medication use in pregnancy in relation to the risk of isolated clubfoot in offspring. Am J Epidemiol 2014;180(1):86-93. doi: 10.1093/aje/kwu096. PMCID: PMC4133556.
  • Van Bennekom CM, Mitchell AA. Comments on: Are Food and Drug Administration prescription drug safety plans working? A case study of isotretinoin [letter to the editor]. Pharmacoepidemiol Drug Saf 2014;23(4):439. doi: 10.1002/pds.3573.
  • Van Zutphen AR, Werler MM, Browne MM, Romitti PA, Bell EM, McNutt LA, Druschel CM, Mitchell AA, and the National Birth Defects Prevention Study. Maternal hypertension, medication use, and hypospadias in the National Birth Defects Prevention Study. Obstet Gynecol 2014;123(2):309-17. doi: 10.1097/AOG.0000000000000103.
  • Vernacchio L, Corwin MJ, Vezina RM, Pelton SI, Feldman HA, Coyne-Beasley T, Mitchell AA. Xylitol syrup for the prevention of acute otitis media. Pediatrics 2014;133(2):289-95. doi: 10.1542/peds.2013-2373. PMCID: PMC3904279.
  • Parker SE, Yazdy MM, Mitchell AA, Demmer LA, Werler MM. A description of spina bifida cases and co-occurring malformations, 1976-2011. Am J Med Genet 2014;164(2):432-40. doi: 10.1002/ajmg.a.36324. PMCID: PMC4353584.
  • Chambers CD, Johnson D, Xu R, Luo Y, Louik C, Mitchell AA, Schatz M, Jones KL, and the OTIS Collaborative Research Group. Risks and safety of pandemic H1N1 influenza vaccine in pregnancy: birth defects, spontaneous abortion, preterm delivery, and small for gestational age infants. Vaccine 2013;31(44):5026-32. doi: 10.1016/j.vaccine.2013.08.097.
  • Louik C, Ahrens K, Kerr S, Pyo J, Chambers C, Jones KL, Schatz M, Mitchell AA. Risks and safety of pandemic H1N1 influenza vaccine in pregnancy: exposure prevalence, preterm delivery, and specific birth defects. Vaccine 2013;31(44):5033-40. doi: 10.1016/j.vaccine.2013.08.096.
  • Li Q, Mitchell AA, Werler MM, Yau WP, Hernández-Díaz S. Assessment of antihistamine use in early pregnancy and birth defects. J Allergy Clin Immunol Pract 2013;1(6):666-74.e1. doi: 10.1016/j.jaip.2013.07.008. PMCID: PMC4140658.
  • Yazdy MM, Mitchell AA, Tinker SC, Parker SE, Werler MM. Periconceptional use of opioids and the risk of neural tube defects. Obstet Gynecol 2013;122(4):838-44. doi: 10.1097/AOG.0b013e3182a6643c.
  • Lee D, Majumdar SR, Lipton HL, Soumerai SB, Vellozzi C, Chen RT, Glanz J, Marinac-Dabic D, Normand ST, Sedrakyan A, Mitchell AA, Dal Pan GJ, Blackburn S, Manzo C, Seidling HM, Bates DW, Robb MA, Sherman RE, Strom BL, Schinnar R, Hennessy S. Special applications of pharmacoepidemiology. In: Strom BL, Kimmel SE, Hennessy S, eds. Textbook of pharmacoepidemiology. 2nd ed. West Sussex, UK: Wiley-Blackwell, 2013:339-406.
  • Lesko SM, Mitchell AA. The use of randomized controlled trials for pharmacoepidemiology studies. In: Strom BL, Kimmel SE, Hennessy S, eds. Textbook of pharmacoepidemiology. 2nd ed. West Sussex, UK: Wiley-Blackwell, 2013:269-79.
  • Benedum CM, Yazdy MM, Mitchell AA, Werler MM. Risk of spina bifida and maternal cigarette, alcohol, and coffee use during the first month of pregnancy. Int J Environ Res Public Health 2013;10:3263-81. doi: 10.3390/ijerph10083263.
  • Thorpe PG, Gilboa SM, Hernández-Díaz S, Lind J, Cragan JD, Briggs G, Kweder S, Friedman JM, Mitchell AA, Honein MA, and the National Birth Defects Prevention Study. Medications in the first trimester of pregnancy: most common exposures and critical gaps in understanding fetal risk. Pharmacoepidemiol Drug Saf 2013;22(9):1013-8. doi: 10.1002/pds.3495. PMCID: PMC3996804.
  • Yau WP, Mitchell AA, Lin KJ, Werler MM, Hernández-Díaz S. Use of decongestants during pregnancy and the risk of birth defects. Am J Epidemiol 2013;178(2):198-208. doi: 10.1093/aje/kws427. PMCID: PMC3816336.
  • Ahrens KA, Anderka MT, Feldkamp ML, Canfield MA, Mitchell AA, Werler MM, and the National Birth Defects Prevention Study. Antiherpetic medication use and the risk of gastroschisis: findings from the National Birth Defects Prevention Study, 1997-2007. Paediatr Perinat Epidemiol 2013;27(4):340-5. doi: 10.1111/ppe.12064. PMCID: PMC3690801.
  • Parker SE, Yazdy MM, Tinker SC, Mitchell AA, Werler MM. The impact of folic acid intake on the association among diabetes mellitus, obesity, and spina bifida. Am J Obstet Gynecol 2013;209(3):239.e1-8. doi: 10.1016/j.ajog.2013.05.047.
  • Werler MM, Yazdy MM, Mitchell AA, Meyer RE, Druschel CM, Anderka M, Kasser JR, Mahan ST. Descriptive epidemiology of idiopathic clubfoot. Am J Med Genet A 2013;161(7):1569-78. doi: 10.1002/ajmg.a.35955. PMCID: PMC3689855.