Studies of Drug Safety during Pregnancy

Psychiatry and Neurology
  1. Hernandez-Diaz S, Huybrechts KF, Desai RJ, Cohen JM, Mogun H, Pennell PB, Bateman BT, Patorno E.Topiramate use early in pregnancy and the risk of oral clefts: A pregnancy cohort study. Neurology. 2018 Jan 23;90(4):e342-e351. doi: 10.1212/WNL.0000000000004857. Epub 2017 Dec 27. PMID: 29282333
  2. Huybrechts KF, Bröms G, Brix Christensen L, Einarsdóttir K, Engeland A, Furu K, Gissler M, Hernandez-Diaz S, Karlsson P, Karlstad Ø, Kieler H, Lahesmaa-Korpinen A-M, Mogun H, Nørgaard M, Reutfors J, Toft Sørensen H, Zoega H, Bateman BT. Stimulant Use in Pregnancy and Risk of Congenital Malformations: A cohort study from the International Pregnancy Safety Study (InPreSS) Consortium. JAMA Psychiatry. 2018 Feb 1;75(2):167-175. doi: 10.1001/jamapsychiatry.2017.3644. PMID: 29238795
    1. Editorial:  Cooper WO, Shedding light on the risks of methylphenidate and amphetamine in pregnancy. JAMA Psychiatry. 2018 Feb 1;75(2):127-128. doi: 10.1001/jamapsychiatry.2017.3882. PMID: 29238801
  3. Cohen JM, Hernandez-Diaz S, Bateman BT, Park Y, Desai RJ, Gray KJ, Patorno E, Mogun H, Huybrechts KF. Placental complications associated with psychostimulant use in pregnancy. Obstet Gynecol. 2017 Dec;130(6):1192-1201. PMID: 29112657
  4. Huybrechts KF, Bateman BT, Desai RJ, Hernandez-Diaz S, Rough K, Mogun H, Kerzner LS, Davis JM, Stover M, Bartels D, Cottral J, Patorno E.  Risk of Neonatal Drug Withdrawal after Intrauterine Co-Exposure to Opioids and Psychotropic Medications: A Cohort Study. BMJ 2017;358: p. j3326-j3326 PMID: 28768628
    1. Editorial: Patrick SW, Cooper WO, Davis MM. Prescribing opioids and psychotropic drugs in pregnancy. BMJ 2017; 358: p. j3616-j3616 PMID: 28768614
  5. Park Y, Huybrechts KF, Cohen JM, Bateman BT, Desai RJ, Patorno E, Mogun H, Cohen LS, Hernandez-Diaz S. Antipsychotic Medication Use Among Publicly Insured Pregnant Women in the United States. Psychiatr Serv. 2017 Jun 15:appips201600408. doi: 10.1176/appi.ps.201600408. [Epub ahead of print] PMID: 28617210
  6. Patorno E, Bateman BT, Huybrechts KF, MacDonald SC, Cohen JM, Desai RJ, Panchaud A, Mogun H, Pennell PB, Hernandez-Diaz S.  Pregabalin use early in pregnancy and the risk of major congenital malformations.  Neurology. 2017 May 23;88(21):2020-2025. PMID: 28446648
  7. Patorno E, Huybrechts KF, Bateman BT, Cohen JM, Desai RJ, Mogun H, Cohen LS, Hernandez-Diaz S. Lithium Use in Pregnancy and the Risk of Cardiac Malformations. NEJM 2017;376:2245-54. PMID: 28854098
  8. Oberg AS, D’Onofrio BD, Rickert ME, Hernandez-Diaz S, Ecker JL, Almqvist C, Larsson H, Lichtenstein P, Bateman BT Labor Induction and Offspring Risk of Autism Spectrum Disorders. JAMA Pediatrics. 2016 Jul 25:e160965. PMID: 27454803
    1. Editorial: Coury, DL. What are the facts about autism spectrum disorders, selective serotonin reuptake inhibitors, and assisted reproductive technology? JAMA Pediatrrics. 2016;170(9):e161444. PMID: 27454061
  9. Huybrechts KF, Hernandez-Diaz S, Patorno E, Desai RJ, Mogun H, Dejene SZ, Cohen JM, Panchaud A, Cohen L, Bateman BT. Antipsychotic Medication Use in Pregnancy and the Risk for Congenital Malformations. JAMA Psychiatry 2016;73(9):938-46. PMID: 27540849
    1. Editorial: Wisner KL, Jeong H, Chambers C. Use of Antipsychotics During Pregnancy: Pregnant Women Get Sick-Sick Women Get Pregnant. JAMA Psychiatry 2016;73(9):901-3. PMID: 27552366
  10. Palmsten K, Hernandez-Di¬az S, Chambers CD, Mogun H, Lai S, Gilmer TP, Huybrechts KF. The Most Commonly Dispensed Prescription Medications Among Pregnant Women Enrolled in the U.S. Medicaid Program. Obstet Gynecol. 2015 Sep;126(3):465-73. PMID: 26244530
    1. Editorial: Chescheir NC. Not Your Grandfather's Prescription Pad. Obstet Gynecol. 2015 Sep;126(3):463-4 PMID: 26244526
  11. Huybrechts KF, Palmsten K, Avorn J, Cohen LS, Holmes LB, Franklin JM, Mogun H, Levin R, Kowal M, Setoguchi S, Hernandez-Diaz S. Antidepressant Use in Pregnancy and the Risk of Cardiac Defects. The New England Journal of Medicine 2014; 19;370(25):2397-407. PMID: 24941178
  12. Palmsten K, Hernández-Díaz S, Huybrechts KF, Williams PL, Michels KB, Achtyes ED, Mogun H, Setoguchi S. Antidepressant Use Near Delivery and Risk of Postpartum Hemorrhage in a Nationwide US Cohort of Low Income Women. The British Medical Journal 2013 Aug 21;347:f4877. doi: 10.1136/bmj.f4877. PMID: 23965506
  13. Palmsten K, Huybrechts KF, Michels KB, Williams PL, Mogun H, Setoguchi S, Hernández-Díaz S.  Antidepressant Use and Risk for Preeclampsia. Epidemiology. 2013 Sep;24(5):682-691. PMID: 23873072
  14. Huybrechts KF, Palmsten K, Mogun H, Kowal M, Avorn J, Setoguchi-Iwata S, Hernandez-Diaz S. National trends in antidepressant medication treatment among publicly-insured pregnant women. General Hospital Psychiatry 2013; 35(3):265-7.1 PMID: 23374897

Opioids
  1. Rough K, Huybrechts KF, Hernandez-Diaz S, Desai RJ, Patorno E, Bateman BT. Using prescription claims to detect aberrant behaviors with opioids: comparison and validation of 5 algorithms. Pharmacoepidemiol Drug Saf. 2018 Apr 24. doi: 10.1002/pds.4443. [Epub ahead of print]. PMID: 29687539
  2. Bateman BT, Cole NM, Maeda A, Burns SM, Houle TT, Huybrechts KF, Clancy CR, Hopp SB, Ecker JL, Ende H, Grewe K, Raposo Corradini B, Schoenfeld RE, Sankar K, Day LJ, Harris LC, Booth JL, Flood P, Bauer ME, Tsen LC, Leffert LR, Landau R. Patterns of opioid prescription and use after cesarean delivery. Obstetrics and Gynecology. 2017 Jul;130(1):29-35. PMID: 28594763
    1. ​Editorial: Patrick, SW. A comprehensive approach to the opioid epidemic. 2017 Jul;130(1):7-9. PMID: 28594781
  3. Desai RJ, Huybrechts KF, Hernandez-Diaz S, Mogun H, Patorno E, Kaltenbach K, Kerzner LS, Bateman BT. Exposure to prescription opioid analgesics in utero and risk of neonatal abstinence syndrome: population based cohort study. BMJ. 2015 May 14;350:h2102. PMID: 25975601
  4. Desai RJ, Hernandez-Diaz S, Bateman BT, Huybrechts KF. Increase in prescription opioid use during pregnancy among Medicaid-enrolled women.  Obstetrics & Gynecology 2014; 123(5):997-1002. PMID: 24785852
  5. Bateman BT, Hernandez-Diaz S, Rathmell J, Seeger JD, Doherty M, Fischer MA, Huybrechts KF. Patterns of opioid utilization in pregnancy in a large cohort of commercial insurance beneficiaries in the United States. Anesthesiology. 2014 May;120(5):1216-24. PMID: 24525628

Cardiovascular
  1. Bateman BT, Patorno E, Desai RJ, Seely EW, Mogun H, Dejene SZ, Fischer MA, Friedman AM, Hernandez-Diaz S, Huybrechts KF. Angiotensin-Converting Enzyme Inhibitors and the Risk of Congenital Malformations. Obstet Gynecol. 2017;129(1):174-184. PMID: 27926639
  2. Bateman BT, Patorno E, Desai RJ, Seely EW, Mogun H, Maeda A, Fischer MA, Hernandez-Diaz S, Huybrechts KF.  Late Pregnancy β Blocker Exposure and Risks of Neonatal Hypoglycemia and Bradycardia. Pediatrics. 2016 Sep;138(3). pii: e20160731. PMID: 27577580
    • Editorial: Synnes A. Screening for Neonatal Hypoglycemia After Fetal Exposure to β-Blockers. Pediatrics. Sep 2016, 138 (3) e20161691. PMID: 27577577
  3. Bateman BT, Huybrechts KF, Maeda A, Desai R, Patorno E, Seely EW, Ecker JL, Allen-Coleman C, Mogun H, Hernandez-Diaz S, Fischer MA. Calcium Channel Blocker Exposure in Late Pregnancy and the Risk of Neonatal Seizures. Obstet Gynecol. 2015 Aug;126(2):271-8. PMID: 26241414
  4. Huybrechts KF, Bateman BT, Palmsten K, Desai RJ, Patorno E, Gopalakrishnan C, Levin R, Mogun H, Hernandez-Diaz S. Antidepressant use late in pregnancy and risk of persistent pulmonary hypertension of the newborn. JAMA. 2015 Jun 2;313(21):2142-51. PMID: 26034955
  5. Bateman BT; Hernandez-Diaz S, Fischer MA; Seely EW; Ecker JL; Franklin JM; Desai RJ; Allen-Coleman C; Mogun H; Avorn J; Huybrechts KF. Statins and congenital malformations: a cohort study. BMJ 2015 Mar 17;350:h1035. PMID: 25784688
    • Editorial: Haramburu F, Daveluy A, Miremont-Salamé G. Statins in pregnancy: new safety data are reassuring, but suspension of treatment is still advisable. BMJ. 2015 Mar 17;350:h1484. PMID: 25784692
  6. Bateman BT, Huybrechts KF, Fischer MA, Seely EW, Ecker JL, Oberg AS, Franklin JM, Mogun H, Hernandez-Diaz S. Chronic hypertension in pregnancy and the risk of congenital malformations: a cohort study. Am J Obstet Gynecol. 2015 Mar; 212(3):337.e1-14. PMID: 25265405
  7. Bateman BT, Hernandez-Diaz S, Huybrechts KF, Palmsten K, Mogun H, Ecker JL, Seely EW, Fischer MA. Outpatient Calcium Channel Blockers and the Risk of Postpartum Hemorrhage: A Cohort Study. British Journal of Obstetrics and Gynecology 2013;120(13):1668-77. PMID: 24020971
  8. Bateman BT, Hernandez-Diaz S, Huybrechts KF, Palmsten K, Mogun H, Ecker JL, Fischer MA. Patterns of outpatient antihypertensive medication use during pregnancy in a Medicaid population. Hypertension 2012;60(4):913-20. PMID: 22966012

Rheumatology
  1. Desai RJ, Bateman BT, Huybrechts KF, Patorno E, Hernandez-Diaz S, Park Y, Dejene SZ, Cohen J, Mogun H, Kim SC. Risk of serious infections associated with use of immunosuppressive agents in pregnant women with autoimmune inflammatory conditions: cohort study. BMJ 2017; 356:j895. PMID: 28264814
  2. Desai RJ, Huybrechts KF, Bateman BT, Hernandez-Diaz S, Mogun H, Gopalakrishnan C, Patorno E, Kim SC. Patterns and secular trends in use of immunomodulatory agents during pregnancy in women with rheumatologic conditions. Arthritis Rheumatol. 2016; 68(5):1183-9. PMID: 26606742

HIV
  1. Rough K, Seage GR, Williams PL, Hernandez-Diaz S, Huo Y, Chadwick EG, Currier JS, Hoffman RM, Barr E, Shapiro DE, Patel K; PHACS and the IMPAACT P1025 Study Teams. Birth Outcomes for Pregnant Women with HIV Using Tenofovir-Emtricitabine. N Engl J Med. 2018 Apr 26;378(17):1593-1603. doi: 10.1056/NEJMoa1701666. PMID: 29694825
  2. Rough K, Sun JW, Seage GR 3rd, Williams PL, Huybrechts KF, Bateman BT, Hernandez-Diaz S. Zidovudine use in pregnancy and congenital malformations: meta-analysis and Bayesian incorporation of medicaid data. AIDS. 2017 Jul 31;31(12):1733-1743. doi: 10.1097/ QAD.0000000000001549. PMID: 28537936

Methods Oriented Publications

  1. Desai R, Rothman K, Bateman BT, Hernandez-Diaz S, Huybrechts KF. A Propensity-score-based Fine Stratification Approach for Confounding When Exposure is Infrequent. Epidemiology 2017 Mar;28(2):249-257. PMID: 27922533
  2. Rough K, Bateman BT, Patorno E, Desai RJ, Park Y, Hernandez-Diaz S, Huybrechts KF. Suppression of substance abuse claims in Medicaid data and Rates of Diagnoses for Non-Substance Abuse Conditions. JAMA 2016; 315(11):1164-6. PMID: 26978213
  3. Swanson SA, Hernandez-Diaz S, Palmsten K, Mogun H, Olfson M, Huybrechts KF. Methodological considerations in assessing the effectiveness of antidepressant medication continuation during pregnancy using administrative data. Pharmacoepidemiol Drug Saf. 2015 Sep;24(9):934-42. PMID: 26045370
  4. Palmsten K, Huybrechts KF, Kowal MK, Mogun H, Hernández-Díaz S. Validity of maternal and infant outcomes within nationwide Medicaid data. Pharmacoepidemiol Drug Saf. 2014;23(6):646-55. PMID: 24740606
  5. Palmsten K, Huybrechts KF, Mogun H, Kowal MK, Williams PL, Michels KB, Setoguchi S, Hernández-Díaz S.  Harnessing the Medicaid Analytic eXtract (MAX) to Evaluate Medications in Pregnancy: Design Considerations. PLoS One. 2013 Jun 26;8(6):e67405. PMID: 23840692
  6. Bateman BT, Mhyre JM, Hernandez-Diaz S, Huybrechts KF, Fischer MA, Creanga AA, Callaghan WM, Gagne JJ. Development of a comorbidity index for use in obstetric patients. Obstet Gynecol. 2013 Nov;122(5):957-65. PMID: 24104771
    • Editorial: Macrones GA. Understanding and reducing serious maternal morbidity: a step in the right direction. Obstet Gynecol. 2013 Nov;122(5):945-6. PMID: 24104767​
H4P is a program of Harvard T.H. Chan School of Public Health and the Division of Phamacoepidemiology & Pharmacoeconomics 
Department of Medicine at Brigham & Women's Hospital and Harvard Medical School
1620 Tremont Street Suite 3030 | Boston, MA 02120 | 617-278-0930​ | h4p@bwh.harvard.edu