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Toxicological information

Health surveillance data

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Administrative data

Endpoint:
health surveillance data
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Study period:
1990
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Data not sufficient for evaluation. Case-control study used for read-across. Lithium substance not exactly specified.

Data source

Reference
Reference Type:
publication
Title:
A Case-Control Study on the Association Between First Trimester Exposure to Lithium and Ebstein's Anomaly
Author:
Zalzstein, E. et al.
Year:
1990
Bibliographic source:
THE AMERICAN JOURNAL OF CARDIOLOGY MARCH 15, 1990

Materials and methods

Study type:
medical monitoring
Endpoint addressed:
developmental toxicity / teratogenicity
Test guideline
Qualifier:
no guideline followed

Test material

Constituent 1
Chemical structure
Reference substance name:
Lithium carbonate
EC Number:
209-062-5
EC Name:
Lithium carbonate
Cas Number:
554-13-2
Molecular formula:
CH2O3.2Li
IUPAC Name:
dilithium carbonate

Method

Type of population:
other: children with Ebstein's anomaly
Ethical approval:
not specified

Results and discussion

Results:
No clear causal link between lithium and Ebstein's anomaly was found in this study.

Applicant's summary and conclusion

Conclusions:
No causal link between Lithium in drug and Ebstein's anomaly was found in a case control study.
Executive summary:

In a case-control study, 59 cases of Ebstein's anomaly were analysed and looked for associations with in-utero exposure to lithium. A control group of children born with neuroblastoma was used to overcome the bias towards "underreporting" of drug exposure by mothers of healthy babies. There was one case of lithium exposure in the control group but none in the Ebstein group. Based on the incidence of Ebstein's anomaly (1:20,000) and the estimation that 1:1,000 pregnant women are treated with lithium, the authors conclude that the study with 59 Ebstein cases has the statistical power of 80% to rule out an increased risk for Ebstein's anomaly due to lithium exposure of more than 28-fold at the p=0.05 level. However, no clear conclusion can be drawn that Lithium exposition during pregnancy is linked to an increase rate for Ebstein's anomaly.

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