National Birth Defect Registry The National Birth Defect
National Birth Defect Registry The National Birth Defect Registry collects data on both structural (i.e. cleft palate, spina bifida) and functional (i.e. attention disorders, autism) birth defects and health, exposure and genetic histories in both parents. Exposures in cases of a particular birth defect are compared to all the non-exposed cases in the registry. The registry is used to detect patterns of birth defects with similar exposures. The use of malformed controls is well-established in the literature and offers the advantage of comparable levels of maternal recall bias in both study cases and controls. 02/11/2020 Studies Using Malformed Controls PLoS One. 2012;7(10):e46626. doi: 10.1371/journal.pone.0046626. Epub 2012 Oct 3. Methodological approaches to evaluate teratogenic risk using birth defect registries: advantages and disadvantages. Birth Defects Res A Clin Mol Teratol. 2006 Aug;76(8):592-601. Maternal severe migraine and risk of congenital limb deficiencies Eur J Epidemiol. 2006;21(1):65-75. Population-based case-control study of the common cold during pregnancy and congenital abnormalities. Birth Defects Res A Clin Mol Teratol. 2005 Dec;73(12):997-1005. Population-based case-control study of isolated congenital cataract. Paediatr Perinat Epidemiol. 2017 Nov;31(6):549-559. doi: 10.1111/ppe.12401. Epub 2017 Aug 25 Gastroschisis in Europe - A Case-malformed-Control Study of Medication and Maternal Illness during Pregnancy as Risk Factors. 02/11/2020 Sudafed (pseudoephedrine) Sudafed (pseudoephedrine) is an over-the-counter medication used for temporary relief of stuffy nose and sinus pain/pressure caused by colds, flu or allergic illnesses such as hay fever and allergies. It works by narrowing the blood vessels to decrease swelling and congestion. In 2006, the Combat Methamphetamine Epidemic Act banned the over-thecounter sales of medicines containing pseudoephedrine, because it is commonly used to make methamphetamine. The sale of cold medicines containing pseudoephedrine is now limited to behind the counter. Studies have found associations between pseudoephedrine and increases in certain birth defects including ventricular septal defects, gastroschisis, intestinal atresia and Goldenhar Syndrome (hemifacial macrosomia). Animal studies have found abnormal sperm and lower sperm rates. 02/11/2020 Pseudoephedrine 1) Sperm abnormalities/ lower rates https://www.ncbi.nlm.nih.gov/pubmed/22644002 2) Ventricular septal defects https://www.ncbi.nlm.nih.gov/pubmed/15448957
3) Gastroschisis, Intestinal Atresia and Goldenhar (hemifacial macrosomia) https://www.ncbi.nlm.nih.gov/pubmed/16933214 4) Gastroschisis association. https://www.ncbi.nlm.nih.gov/pubmed/12859037 5) GastroschisisSudafed and acetaminophin. https://www.ncbi.nlm.nih.gov/pubmed/11772781 6) Gastroschisis Sudafed and acetaminophin https://www.ncbi.nlm.nih.gov/pubmed/1533958 7) Use of Decongestants During Pregnancy https://academic.oup.com/aje/article/178/2/198/122453 02/11/2020 Results from the National Birth Defect Registry In the National Birth Defect Registry, data on 442 Sudafed-exposed cases compared to 5527 non-exposed cases have shown increases of a doubling or more for ventricular septal defects, gastroschisis, rectal/anal atresia, Goldenhar Syndrome (hemifacial macrosomia) and other categories of structural birth defects that have not been the subject of published studies. 02/11/2020 Sudafed Heart 12 10 9.65 8 6 4 3.77 3.47
1.93 2 1.44 1.16 0.44 Cortical Blindness Hypertelorism Ext ear absent or malf 442 Exposed 02/11/2020 5527 Not Exposed Ear Tag Early tooth eruption Clomid (clomiphene) Clomid (clomiphene citrate) is a medication used to treat infertility in women. It works by stimulating hormones so that ovaries release mature eggs. Clomid is not available in Canada and there are some reports that the manufacturer may no longer make Clomid in the U.S. Clomid has been associated with anencephaly, Dandy Walker, heart defects, cloacal exstrophy, omphalocele, traceoesphageal fistula, craniosynostosis, autism and hypospadias. 02/11/2020 Clomid 1) NTDs, TEF, Omphalocele et al http://www.mblynchfirm.com/2018/08/28/australian-researchers-link-clomid-to-birth-defects/ 2) Anencephaly,Dandy Walker/Heart defects et al https://www.ncbi.nlm.nih.gov/pubmed/?term=clomid+and+cloacal+exstrophy 3) Hypospadias (mild / moderate) https://www.ncbi.nlm.nih.gov/pubmed/16586447 4) Hypospadias & NTDs https://www.ncbi.nlm.nih.gov/pubmed/18519067 5) NTDs and hypospadias https://www.ncbi.nlm.nih.gov/pubmed/28547654
6) Autism http://blogs.edweek.org/edweek/speced/2010/05/research_links_autism_to_infer.html 7) Craniosynostosis https://www.ncbi.nlm.nih.gov/pubmed/23428561 02/11/2020 Results from the National Birth Defect Registry Data from the National Birth Defect Registry on 60 Clomid-exposed case compared to 5907 non-exposed cases found increases in traceoephageal fistula, omphalocele, hypospadias, craniosynostosis, anencephaly and autism. Certain heart defects, cloacal anomaly and Dandy Walker were also increased, but not included because they were based on less than 2 Clomid exposures. 02/11/2020 Clom CNS/Neurodevelopmental id 8 7 6.67 6.67 6 5 5 5 4 3.33 3 3.54 3.33 2.67 2.32
8.33 8.33 8 7 6 5 4 4.08 3.33 2.79 3 2 1.3 1 0 Frequent Pneumonia Chronic Virus 60 Exposed 02/11/2020 Immune Deficiency 5907 Not Exposed 24 Zoloft (sertraline) Zoloft (sertraline hydrochloride) is a medication prescribed to treat depression as well as other disorders like OCD, panic and social anxiety and PTSD. Zoloft is classified as a selective serotonin reuptake inhibitor (SSRI). SSRIs affect serotonin in the brain and have been associated with birth defects. The FDA categorizes Zoloft in Pregnancy Category C which means that reproductive studies in animals have shown evidence of fetal harm. Published studies have found links between Zoloft and septal heart defects, clubfoot, oral clefts, autism, omphalocele and craniosynostosis. 02/11/2020 Zoloft 1)Heart defects, VSDs, ASDS https://www.ncbi.nlm.nih.gov/pubmed/27770542
2)ASDs/VSDs Craniosynostosis https://www.ncbi.nlm.nih.gov/pubmed/25637841 3)Clubfoot https://www.ncbi.nlm.nih.gov/pubmed/25171134 4)Septal heart defects https://www.ncbi.nlm.nih.gov/pubmed/19776103 5)Omphalocele/septal defects https://www.ncbi.nlm.nih.gov/pubmed/17596601 6)Autism https://www.bmj.com/content/346/bmj.f2059 02/11/2020 Results from the National Birth Defect Registry Data from the National Birth Defect Registry compared birth defects in 105 Zoloft-exposed cases to 5863 non-exposed cases. Increases were found for septal heart defects, clubfoot and autism also found in published studies. Omphalocele was increased, but not included since less than 2 cases were exposed to Zoloft. 02/11/2020 Zoloft Heart and Lung 10 8.86 9 8.86 8 7.59 7 6 5.06 5 3.96
4 3 3.55 3.53 2.53 2.53 2.43 2 0.95 1 0 Tr i os p s an n tio Gr ea ri e te r tA 0.73 s r nt Ve la ic u al
pt e rS t ec f De r ia t A al pt e lS t ec f De B ve ng Lu 105 Exposed 2/14/2019 id sp u ic rti Ao al V c 5863 Not Exposed r de n U or t
n se b (A d) e op el v de Ri b m or n Ab ai y lit Zoloft Limb and Muscle 18 16.46 16 14 12 10 8 8.86 8.86 7.59 6 5.06 5.26 5.06 4.31
3.80 2.53 2.53 1.82 2 1.72 1.68 1.05 1 0.59 0 T om ris 0.46 0.27 y D g or e iG e m ro h C om os e D r
de r iso e un r P lly t or Sh l we o B na o uti tit s n Co 105 Exposed 2/14/2019 Be 5863 Not Exposed r ho S l e ur t ta tS In o er t U h
wt o Gr Re ta ati rd on Zofran (ondansetron) Zofran (ondansetron) is an anti-nausea drug and selective 5-HT3 receptor antagonist prescribed for the treatment of nausea and vomiting due to cancer chemotherapy and also used to prevent and treat nausea and vomiting after surgery. Zofran is not an FDA approved medication for pregnant women experiencing morning sickness and should not be taken during pregnancy. Published studies have found significant associations between Zofran and heart defects, clefts and renal agenesis. 02/11/2020 Zofran 02/11/2020 Heart defects/clefts https://www.ncbi.nlm.nih.gov/pubmed/30385129 Cleft palate, renal agenesis https://www.ncbi.nlm.nih.gov/pubmed/29995744 Septal heart defects https://www.ncbi.nlm.nih.gov/pubmed/25450422 Cleft palate http://www.motherisk.org/prof/updatesDetail.jsp?content_id=982 Results from the National Birth Defect Registry Data from the National Birth Defect Registry compared birth defects in 177 Zofran-exposed cases to 5973 non-exposed cases. Increases were found for heart defects and high arched palate. Significant increases were also found for gastroschisis, NTDs and other birth defects
that have not been reported in published studies. 02/11/2020 Zofran Zofran and Heart Defects 4 3.6 3.6 3.5 2.88 3 2.5 2.16 2.16 2 1.44 1.5 1.44 0.74 0.55 0.5 0 rti Ao 1.44 1.44 1.17 1 a cV 1.44 1.2
lve sis o en St B d pi s i cu rti Ao al V c ve B c dy a r 0.43 0.34 a di r a Ca m io rd a eg ly c tro x De
a di r a H pl o yp 177 Exposed 02/11/2020 tic as 0.5 0.43 g Ri ht ar He t M itr a 0.33 0.22 al V l ve sis o en St lm
Pu ar on sia e tr yA lm Pu ar on al V y ve sis o en St Tr d pi s ic u l Va ve sis o en St 5791 Not Exposed 38 Zofran CNS, Craniofacial, Eye & Spine 10 8.63
9 8 7.19 7 6 5 3.6 4 3.79 3.6 3 2 2.16 1.49 1.44 1 0.7 0 e nc e s Ab m tu p Se of c en n A al h ep y
a ph e c En e el c lo c en s ro op l Ho 0.6 al h ep y 1.44 0.81 al h ep oc r d Hy us in Th 177 Exposed 02/11/2020 1.84 1.44 0.31 4.07
3.6 C us p r Co a m su ll o ny o B 1.44 0.6 t ec f De O ll ku S f Hi gh d he c Ar l Pa e at E 0.48 a pi
rt o xo c Sa ra is es n ge A l 5791 Not Exposed 39 Zofran Gastrointestinal & Genitourinary 16 14.39 14 12 10 8 6 5.20 5.04 4 2.16 2 0 1.44 1.12 si hi c s tro s Ga s c
ni e g ro u Ne el w Bo Om a ph 2.88 2.16 0.53 le ce o l a ct e R a tin s e nt I r lo 0.87 sia rt e lA 0.43 t or h S el
w Bo ac lo a m no A l al y e ho s e rs o H 2.23 2.16 0.58 0.22 C 177 Exposed 02/11/2020 2.16 1.44 ey dn i K 0.75 le ce o dr Hy
c ni e og ur e N Bl er d ad 5791 Not Exposed 40 Zofran Muscle, Limb & Syndrome 10 9.35 9 8 7 5.76 6 5 5.76 4.60 4 3.60 3 2.16 2.16 2 1 1.44 0.53
1.29 0.74 1.44 0.53 0.82 0.91 0.98 0 177 Exposed 02/11/2020 5791 Not Exposed 41 Bendec tin Bendectin was an anti-nauseant medication, on the market from 1956-1982, recommended solely for morning sickness in pregnancy. The drug was a combination of an antihistamine (doxylamine succinate), an antispasmodic (dicylcomine hydrochloride) and vitamin B-6 (pyridoxine). In epidemiological studies, Bendectin was associated with increases in limb defects, heart defects, oral clefts, pyloric stenosis, amniotic band limb defects, encephalocele, diaphragmatic hernias and musculoskeletal defects. Bendectin was taken off the world-wide market in 1982. 02/11/2020 CDC: Statistically significant association with amniotic band limb defects and encephalocele. Heinonen: Data consistent for association of BDN with musculoskeletal defects. Jick: Data consistent with modest teratogenic effect on limbs, BDN exposure increases risk of limb defect 120% Michaelis: 36% increased risk of malformations in BDN exposed babies Mitchell: 50% increased risk of limb defects in BDN exposed babies Rothman: Statistically significant association with heart defects Golding: Statistically significant association with oral clefts Eskanaiz/Bracken: Statistically significant association with pyloric stenosis Smithells: 36% increased risk of malformation in BDN exposed babies Bass: 11-fold increase diaphragmatic hernia in BDN exposed babies Maynard: Increase in diaphragmatic hernia in BDN exposed babies in analysis of 5 cohort studies 02/11/2020 Results from the
National Birth Defect Registry Data from the National Birth Defect Registry compared birth defects in 201 Bendectin exposed cases to 5768 non-exposed cases. Increases were found for limb reduction defects, pyloric stenosis, muscle and skeletal defects, clubfoot with bone deformities and other birth defects. 02/11/2020 Bendectin Limb, Chest and Muscle Deformities 16 14 13.41 12 10 201 Exposed 5768 Not Exposed 8 6 4 5.59 5.03 4.47 3.91 3.28 2.3 1.68 2 1.45 1.26 1.69 0.54 0 02/11/2020 Upper limb reductionLower limb reduction Arthrogryposis Clubfoot w/bone defor Pectoralis absent
Nail Tech Exposures Artificial nail technicians are exposed to a number of reproductive toxicants including the solvent toluene, plasticizers like Di-n-butyl phthalate (DBP), acetone and formaldehyde. Toluene has been associated with intrauterine growth retardation, congenital malformations, intellectual disabilities and premature delivery. DBP is believed to cause reproductive toxicity at high exposures over extended periods of time. Formaldehyde is suspected of reproductive toxicity. DBP and formaldehyde have been banned by the European Union. 02/11/2020 Nail Tech Exposures Birth Defects https://www.scientificamerican.com/article/these-4-chemicals-may-pose-the-most-risk-for-nail-salon-workers/ Harm to unborn child https://www.osha.gov/SLTC/nailsalons/chemicalhazards.html NTDs https://www.jstor.org/stable/27797694?seq=1#page_scan_tab_contents/ Birth Defects https://www.p65warnings.ca.gov/fact-sheets/di-n-butyl-phthalate-dbp/ Dev delays/neurobehavioral https://www.ncbi.nlm.nih.gov/pubmed/20377315 Congenital malformation https://www.ncbi.nlm.nih.gov/pubmed/11350197 https://www.nj.gov/health/eoh/rtkweb/documents/fs/1866.pdf Damage develop fetus https://www.nj.gov/health/eoh/rtkweb/documents/fs/0773.pdf Birth Defects 02/11/2020 Results from the National Birth Defect Registry Data from the National Birth Defect Registry compared birth defects in 140 nail-tech cases to 5829 non-exposed cases. Increases were found for anencephaly (NTD). Significant increases were also found for gastroschisis, Autistic Spectrum Disorders and other birth
defects that have not been reported in published studies. 02/11/2020 Artificial Nail Tech Central Nervous System 4 3.57 3.5 3 2.86 2.5 2.14 2 1.5 1.49 1.43 1 0.58 0.46 0.5 0 0.27 Anencephaly Holoprosencephaly 140 Exposed 02/11/2020 Ataxia Delayed Myelination 5829 Not exposed 56 Artificial Nail Tech Eye and Ear 8 7.14 7 6 5
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