Problems of using data from teratology information services (TIS) to identify putative teratogens

Martínez‐Frías, M.L.; Rodríguez‐Pinilla, E.

doi:10.1002/(sici)1096-9926(199908)60:2<54::aid-tera3>3.3.co;2-v

Cited by 7 publications

(6 citation statements)

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“…Limitations of our study are the small numbers and the fact that our cases might not be representative for all pregnant women exposed to AT 1 ‐antagonists. Factors such as higher educational status, anxiety, etc., may be over‐represented among women contacting a teratology information service . However, other authors could not demonstrate a significant influence on the outcome .…”

Section: Discussionmentioning

confidence: 94%

Angiotensin‐II receptor 1 antagonist fetopathy – risk assessment, critical time period and vena cava thrombosis as a possible new feature

Oppermann

Padberg

Kayser

et al. 2013

Brit J Clinical Pharma

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AIMSAngiotensin-II receptor 1 antagonists (AT1-antagonists) may cause severe and even lethal fetopathy in late pregnancy. However, exposure still occurs in spite of warnings in package leaflets. This study aimed to assess the risk of fetopathy, the sensitive time window, and possible new symptoms in prospective as well as retrospective cases with AT1-antagonist treatment during the second or third trimester of pregnancy. METHODSPatients were enrolled by the Berlin Institute for Clinical Teratology and Drug Risk Assessment in Pregnancy between 1999 and 2011 through risk consultation. Symptoms defined as indicative of AT1-antagonist fetopathy were: oligo-/anhydramnios, renal insufficiency, lung hypoplasia, joint contractures, skull hypoplasia and fetal/neonatal death. RESULTSIn 5/29 (17%) prospectively enrolled cases with AT1-antagonist exposure beyond the first trimester oligo-/anhydramnios was diagnosed. Two infants showed additional symptoms of fetopathy. The risk is more than 30% if treatment continues beyond the 20th week of pregnancy. Oligo-/anhydramnios was reversible after AT1-antagonist withdrawal. Among 16 retrospective case reports, three infants presented with a thrombosis of the inferior vena cava in the vicinity of the renal veins. Four out of 13 live births did not survive.

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Section: Discussionmentioning

confidence: 94%

Angiotensin‐II receptor 1 antagonist fetopathy – risk assessment, critical time period and vena cava thrombosis as a possible new feature

Oppermann

Padberg

Kayser

et al. 2013

Brit J Clinical Pharma

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“…There was a discussion on possible bias when evaluating pregnancy outcome of TIS studies [Martinez‐Frias and Rodriguez‐Pinilla, 1999; Ornoy and Mastroiacovo, 2000] and it has been assumed that women contacting TIS might have a higher risk of adverse pregnancy outcome [Johnson et al, 2001]. However, in the experience of many TIS, women contacting TIS are better educated and might have less risk factors than women not contacting a TIS, thus leading even to an underestimation of the malformation risk.…”

Section: Discussionmentioning

confidence: 99%

Teratogenicity of mycophenolate confirmed in a prospective study of the European Network of Teratology Information Services

Hoeltzenbein

Eléfant²,

Vial³

et al. 2012

American J of Med Genetics Pt A

193

111

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After maternal exposure to mycophenolate in pregnancy a high number of fetal losses and a specific pattern of birth defects consisting of microtia, cleft lip, and other anomalies have been reported. However, so far, prospective data on pregnancy outcome allowing quantitative risk assessment are missing. We report on 57 prospectively ascertained pregnancies after maternal therapy with mycophenolate (mycophenolate mofetil or mycophenolate sodium) identified by European Teratology Information Services (ETIS) through their risk consultation process. The outcome of these prospective pregnancies was as follows: 16 spontaneous abortions, 12 elective terminations of pregnancy (ETOP) (including two late terminations for multiple malformations consistent with mycophenolate embryopathy), and 29 liveborn infants. The probability of spontaneous abortion was about 45% (95% CI 29 to 66%) estimated using survival analysis technique. Six out of 29 live born infants had major congenital defects: Two with external auditory canal atresia (EACA) (with and without microtia), one with tracheo-esophageal atresia, one with severe hydronephrosis, one with an atrial septal defect (ASD) and one with a myelomeningocele. Thus, at least four fetuses/infants of our prospective case series had a clinical phenotype consistent with mycophenolate embryopathy. Our results confirm a high incidence of major malformations (26%) after first trimester exposure to mycophenolate. Apart from exposure to mycophenololate, the underlying maternal disease and concomitant medication may also have contributed to the other poor pregnancy outcomes such as a high rate of spontaneous abortions, prematurity (62%), and low birth weight (31%).

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“…This is an important finding, as health agencies and providers may need to develop strategic plans to better engage people with lower levels of education when communicating health information. It is generally believed that TIS users are of a higher socioeconomic status than the general population (Martinez‐Frias,1999; Ornoy and Mastroiacovo,2000; Johnson et al,2001). The interaction between anxiety level and cost is logical and in an expected direction, and potentially indicates that the true value of counseling is related to anxiety reduction.…”

Section: Discussionmentioning

confidence: 99%

Public preferences for counseling regarding antidepressant use during pregnancy: A discrete choice experiment

Hancock-Howard¹,

Ungar

Marshall

et al. 2012

Birth Defects Research

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Problems of using data from teratology information services (TIS) to identify putative teratogens

Cited by 7 publications

References 0 publications

Angiotensin‐II receptor 1 antagonist fetopathy – risk assessment, critical time period and vena cava thrombosis as a possible new feature

Angiotensin‐II receptor 1 antagonist fetopathy – risk assessment, critical time period and vena cava thrombosis as a possible new feature

Teratogenicity of mycophenolate confirmed in a prospective study of the European Network of Teratology Information Services

Public preferences for counseling regarding antidepressant use during pregnancy: A discrete choice experiment

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