Maternal cyclobenzaprine exposure and risk of birth defects in the National Birth Defects Prevention Study (1997–2011) and Birth Defects Study to Evaluate Pregnancy exposureS (2014–2018)

Details

• Alternative Title:
  Pharmacoepidemiol Drug Saf
• Personal Author:
  Fisher, Sarah C. ; Howley, Meredith M. ; Tran, Emmy L. ; Ailes, Elizabeth C. ; Papadopoulos, Eleni A. ; Nembhard, Wendy N. ; Browne, Marilyn L.
• Description:
  Purpose:
  
  Cyclobenzaprine is a muscle relaxant indicated for acute pain. Little is known about cyclobenzaprine’s safety during pregnancy. We explored the association between maternal cyclobenzaprine exposure and risk of birth defects among offspring.
  
  Methods:
  
  We combined data from two large, multi-site, population-based case–control studies in the United States. Cases were identified from birth defects registries across 10 states; controls were liveborn infants without birth defects randomly selected from the same catchment areas. Participants reported cyclobenzaprine use during the month before conception through the third month of pregnancy (“periconception”) via computer-assisted telephone interview. We used logistic regression to assess associations between periconceptional cyclobenzaprine exposure and selected structural birth defects. We calculated crude odds ratios (OR) with corresponding 95% confidence intervals (CI).
  
  Results:
  
  Our study included 33 615 cases and 13 110 controls. Overall, 51 case (0.15%) and 9 control (0.07%) participants reported periconceptional cyclobenzaprine use. We observed increased risk for all seven defects with ≥3 exposed cases: cleft palate (OR = 4.79, 95% CI 1.71–13.44), cleft lip (OR = 2.50, 95% CI 0.89–7.02), anorectal atresia/stenosis (OR = 6.91, 95% CI 1.67, 28.65), d-transposition of the great arteries (OR = 6.97, 95% CI 2.17–22.36), coarctation of the aorta (OR = 5.58, 95% CI 1.88–16.58), pulmonary valve stenosis (OR = 4.55, 95% CI 1.10–18.87), and secundum atrial septal defect (OR = 3.08, 95% CI 0.83–11.45).
  
  Conclusions:
  
  Even in our large sample, cyclobenzaprine use was rare. Our estimates are unadjusted and imprecise so should be interpreted cautiously. These hypothesis-generating results warrant confirmation and further research to explore possible mechanisms.
  
  
• Subjects:
  Case-Control Studies Female Humans Infant Logistic Models Maternal Exposure Pregnancy Risk Factors Transposition Of Great Vessels United States
• Keywords:
  BD-STEPS Birth Defects Cyclobenzaprine Muscle Relaxants NBDPS Pregnancy
• Source:
  Pharmacoepidemiol Drug Saf. 32(8):855-862
• Pubmed ID:
  36942828
• Pubmed Central ID:
  PMC10926911
• Document Type:
  Journal Article
• Funding:
  CDP 13-003/HX/HSRD VAUnited States/ ; FOA #DD09-001/CC/CDC HHSUnited States/ ; U01 DD001227/DD/NCBDD CDC HHSUnited States/ ; PA #96043/CC/CDC HHSUnited States/ ; CC999999/ImCDC/Intramural CDC HHSUnited States/ ; EP-D-18-001/EPA/EPAUnited States/ ; PA #02081/CC/CDC HHSUnited States/ ; FOA #DD13-003/CC/CDC HHSUnited States/ ; U01DD001227/CC/CDC HHSUnited States/ ; U01DD001227/ACL/ACL HHSUnited States/ ; NOFO #DD18-001/CC/CDC HHSUnited States/
• Volume:
  32
• Issue:
  8
• Collection(s):
  CDC Public Access
• Main Document Checksum:
  urn:sha-512:8aff3b28ce45556554469011e8d13072758d3951e34d377af00340fa189fe9024960e57a3cf4fce6b9c6572875745693f3c1bd51617ab6179c6ec7151f31d2ed
• Download URL:
  https://stacks.cdc.gov/view/cdc/151667/cdc_151667_DS1.pdf
• File Type:
  [PDF - 113.70 KB ]