Allen A. Mitchell, M.D.

Allen MitchellDirector Emeritus
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.

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

  • Rhodes ET, Vernacchio L, Mitchell AA, Fischer C, Giacalone P, Ludwig DS, Ebbeling CB. A telephone intervention to achieve differentiation in dietary intake: a randomized trial in pediatric primary care. Pediatr Obes 2017. doi: 10.1111/ijpo.12171 (epub ahead of print).
  • Kerr S, Van Bennekom CM, Mitchell AA. Influenza vaccination coverage during pregnancy — selected sites, United States, 2005–06 through 2013–14 influenza vaccine seasons. MMWR Morb Mortal Wkly Rep 2016;65(48):1370-73. doi: 10.15585/mmwr.mm6548a3.
  • Louik C, Kerr S, Van Bennekom CM, Chambers C, Jones KL, Schatz M, Mitchell AA. Safety of the 2011-12, 2012-13, and 2013-14 seasonal influenza vaccines in pregnancy: preterm delivery and specific malformations. Vaccine 2016;34(37):4450-9. doi: 10.1016/j.vaccine.2016.06.078.
  • Chambers C, Johnson D, Xu R, Luo Y, Louik C, Mitchell AA, Schatz M, Jones KL, and the OTIS Collaborative Research Group. Safety of the 2010-11, 2011-12, 2012-13, and 2013-14 seasonal influenza vaccines in pregnancy: birth defects, spontaneous abortion, preterm delivery, and small for gestational age infants. Vaccine 2016;34(37):4443-9. doi: 10.1016/j.vaccine.2016.06.054.
  • Mitchell AA. Research challenges for drug-induced birth defects [commentary]. Clin Pharmacol Ther 2016;100(1):26-8. doi: 10.1002/cpt.374.
  • Darling AM, Mitchell AA, Werler MM. Preconceptional iron intake and gestational diabetes mellitus. Int J Environ Res Public Health 2016;13(6):E525. doi: 10.3390/ijerph13060525. PMCID: PMC4923982.
  • Benedum CM, Yazdy MM, Parker SE, Mitchell AA, Werler MM. Association of clomiphene and assisted reproductive technologies on the risk for neural tube defects. Am J Epidemiol 2016;183(11):977-87. doi: 10.1093/aje/kwv322. PMCID: PMC4887580.
  • Public Policy Committee, International Society of Pharmacoepidemiology. Guidelines for good pharmacoepidemiology practice (GPP). Pharmacoepidemiol Drug Saf 2016;25:2-10. doi: 10.1002/pds.3891.
  • Simeone RM, Feldkamp ML, Reefhuis J, Mitchell AA, Gilboa SM, Honein MA, Iskander J. CDC Grand Rounds: understanding the causes of major birth defects — steps to prevention. MMWR Morb Mortal Wkly Rep 2015;64(39):1104-7. doi: 10.15585/mmwr.mm6439a3.
  • Benedum CM, Yazdy MM, Mitchell AA, Werler MM. Impact of periconceptional use of nitrosatable drugs on the risk of neural tube defects. Am J Epidemiol 2015;182(8):675-84. doi: 10.1093/aje/kwv126.
  • Louik C, Werler MM, Anderka M, Mitchell AA. Application of data screening to drug exposure in large risk factor studies of birth defects. Birth Defects Res A Clin Mol Teratol 2015;103(8):713-7. doi: 10.1002/bdra.23407.
  • Mitchell AA, Louik C, Chambers C, Jones KL, Schatz M. Immunization surveillance systems for pregnant women [letter to the editor]. Pharmacoepidemiol Drug Saf 2015;24:669. doi: 10.1002/pds.3784.
  • Yazdy MM, Mitchell AA, Louik C, Werler MM. The authors respond [letter to the editor]. Epidemiology 2015;26(3):e35-6. doi: 10.1097/EDE.0000000000000281. PMCID: PMC4388046.
  • 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;122:1002-9. doi: 10.1111/1471-0528.13138.
  • 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: PMC4813306.
  • 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.