Abstract
Background: Sulfonamide antibacterials are widely used in pregnancy, but evidence about their safety is mixed. The objective of this study was to assess the association between first-trimester sulfonamide exposure and risk of specific congenital malformations. Methods: Mother-infant pairs were selected from a cohort of 1.2 million live-born deliveries (2001-2008) at 11 US health plans comprising the Medication Exposure in Pregnancy Risk Evaluation Program. Mothers with first-trimester trimethoprim-sulfonamide (TMP-SUL) exposures were randomly matched 1:1 to (i) a primary comparison group (mothers exposed to penicillins and/or cephalosporins) and (ii) a secondary comparison group (mothers with no dispensing of an antibacterial, antiprotozoal, or antimalarial medication during the same time period). The outcomes were cardiovascular abnormalities, cleft palate/lip, clubfoot, and urinary tract abnormalities. Results: We first identified 7615 infants in the TMP-SUL exposure group, of which 7595 (99%) were exposed to a combination of TMP-SUL and the remaining 1% to sulfonamides alone. After matching (1:1) to the comparator groups and only including those with complete data on covariates, there were 20064 (n=6688 per group) in the primary analyses. Overall, cardiovascular defects (1.52%) were the most common and cleft lip/palate (0.10%) the least common that were evaluated. Compared with penicillin/cephalosporin exposure, and no antibacterial exposure, TMP-SUL exposure was not associated with statistically significant elevated risks for cardiovascular, cleft lip/palate, clubfoot, or urinary system defects. Conclusions: First-trimester TMP-SUL exposure was not associated with a higher risk of the congenital anomalies studied, compared with exposure to penicillins and/or cephalosporins, or no exposure to antibacterials.
| Language | English |
|---|---|
| Pages | 170-178 |
| Number of pages | 9 |
| Journal | Pharmacoepidemiology and Drug Safety |
| Volume | 25 |
| Issue number | 2 |
| DOIs | |
| Publication status | Published - 1 Feb 2016 |
Keywords
- Antibacterial agents
- Birth defects
- Medications
- Pharmacoepidemiology
- Pregnancy
- Sulfonamides
ASJC Scopus subject areas
- Epidemiology
- Pharmacology (medical)
Cite this
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Trimethoprim-sulfonamide use during the first trimester of pregnancy and the risk of congenital anomalies. / Hansen, Craig Anthony; Andrade, Susan E.; Freiman, Heather; Dublin, Sascha; Haffenreffer, Katie; Cooper, William O.; Cheetham, T. Craig; Toh, Sengwee; Li, De Kun; Raebel, Marsha A.; Kuntz, Jennifer L.; Perrin, Nancy; Rosales, A. Gabriela; Carter, Shelley; Pawloski, Pamala A.; Maloney, Elizabeth M.; Graham, David J.; Sahin, Leyla; Scott, Pamela E.; Yap, John; Davis, Robert.
In: Pharmacoepidemiology and Drug Safety, Vol. 25, No. 2, 01.02.2016, p. 170-178.Research output: Contribution to journal › Article
TY - JOUR
T1 - Trimethoprim-sulfonamide use during the first trimester of pregnancy and the risk of congenital anomalies
AU - Hansen, Craig Anthony
AU - Andrade, Susan E.
AU - Freiman, Heather
AU - Dublin, Sascha
AU - Haffenreffer, Katie
AU - Cooper, William O.
AU - Cheetham, T. Craig
AU - Toh, Sengwee
AU - Li, De Kun
AU - Raebel, Marsha A.
AU - Kuntz, Jennifer L.
AU - Perrin, Nancy
AU - Rosales, A. Gabriela
AU - Carter, Shelley
AU - Pawloski, Pamala A.
AU - Maloney, Elizabeth M.
AU - Graham, David J.
AU - Sahin, Leyla
AU - Scott, Pamela E.
AU - Yap, John
AU - Davis, Robert
PY - 2016/2/1
Y1 - 2016/2/1
N2 - Background: Sulfonamide antibacterials are widely used in pregnancy, but evidence about their safety is mixed. The objective of this study was to assess the association between first-trimester sulfonamide exposure and risk of specific congenital malformations. Methods: Mother-infant pairs were selected from a cohort of 1.2 million live-born deliveries (2001-2008) at 11 US health plans comprising the Medication Exposure in Pregnancy Risk Evaluation Program. Mothers with first-trimester trimethoprim-sulfonamide (TMP-SUL) exposures were randomly matched 1:1 to (i) a primary comparison group (mothers exposed to penicillins and/or cephalosporins) and (ii) a secondary comparison group (mothers with no dispensing of an antibacterial, antiprotozoal, or antimalarial medication during the same time period). The outcomes were cardiovascular abnormalities, cleft palate/lip, clubfoot, and urinary tract abnormalities. Results: We first identified 7615 infants in the TMP-SUL exposure group, of which 7595 (99%) were exposed to a combination of TMP-SUL and the remaining 1% to sulfonamides alone. After matching (1:1) to the comparator groups and only including those with complete data on covariates, there were 20064 (n=6688 per group) in the primary analyses. Overall, cardiovascular defects (1.52%) were the most common and cleft lip/palate (0.10%) the least common that were evaluated. Compared with penicillin/cephalosporin exposure, and no antibacterial exposure, TMP-SUL exposure was not associated with statistically significant elevated risks for cardiovascular, cleft lip/palate, clubfoot, or urinary system defects. Conclusions: First-trimester TMP-SUL exposure was not associated with a higher risk of the congenital anomalies studied, compared with exposure to penicillins and/or cephalosporins, or no exposure to antibacterials.
AB - Background: Sulfonamide antibacterials are widely used in pregnancy, but evidence about their safety is mixed. The objective of this study was to assess the association between first-trimester sulfonamide exposure and risk of specific congenital malformations. Methods: Mother-infant pairs were selected from a cohort of 1.2 million live-born deliveries (2001-2008) at 11 US health plans comprising the Medication Exposure in Pregnancy Risk Evaluation Program. Mothers with first-trimester trimethoprim-sulfonamide (TMP-SUL) exposures were randomly matched 1:1 to (i) a primary comparison group (mothers exposed to penicillins and/or cephalosporins) and (ii) a secondary comparison group (mothers with no dispensing of an antibacterial, antiprotozoal, or antimalarial medication during the same time period). The outcomes were cardiovascular abnormalities, cleft palate/lip, clubfoot, and urinary tract abnormalities. Results: We first identified 7615 infants in the TMP-SUL exposure group, of which 7595 (99%) were exposed to a combination of TMP-SUL and the remaining 1% to sulfonamides alone. After matching (1:1) to the comparator groups and only including those with complete data on covariates, there were 20064 (n=6688 per group) in the primary analyses. Overall, cardiovascular defects (1.52%) were the most common and cleft lip/palate (0.10%) the least common that were evaluated. Compared with penicillin/cephalosporin exposure, and no antibacterial exposure, TMP-SUL exposure was not associated with statistically significant elevated risks for cardiovascular, cleft lip/palate, clubfoot, or urinary system defects. Conclusions: First-trimester TMP-SUL exposure was not associated with a higher risk of the congenital anomalies studied, compared with exposure to penicillins and/or cephalosporins, or no exposure to antibacterials.
KW - Antibacterial agents
KW - Birth defects
KW - Medications
KW - Pharmacoepidemiology
KW - Pregnancy
KW - Sulfonamides
UR - http://www.scopus.com/inward/record.url?scp=84955605448&partnerID=8YFLogxK
U2 - 10.1002/pds.3919
DO - 10.1002/pds.3919
M3 - Article
VL - 25
SP - 170
EP - 178
JO - Pharmacoepidemiology and Drug Safety
T2 - Pharmacoepidemiology and Drug Safety
JF - Pharmacoepidemiology and Drug Safety
SN - 1053-8569
IS - 2
ER -