Lithium chloride

Health surveillance data

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:

1973

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: Data not sufficient for evaluation. Retrospective report used for read-across. Lithium substance not exactly specified.

Cross-reference

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

publication

Title:

Lithium and Pregnancy-I, Report from the Register of Lithium Babies

Author:

Schou, M. et al.

Year:

1973

Bibliographic source:

British Medical Journal, 1973, 2, 135-136

Materials and methods

Study type:

health record, other

Remarks:

Register of Lithium Babies

Endpoint addressed:

developmental toxicity / teratogenicity

Test guideline

Qualifier:

no guideline followed

Test material

Test material information

Constituent 1

Reference substance name:

Lithium compounds (not specified)

IUPAC Name:

Lithium compounds (not specified)

Method

Type of population:

other: "lithium babies" born of a woman who had been treated with lithium during the first trimester of pregnancy

Ethical approval:

not specified

Details on study design:

The Register of Lithium Babies started on a Scandinavian basis, but soon reports also arrived from outside Scandinavia. During the past few years information has been collected in the United States and Canada.
The existence of the Register has been announced through notes published at intervals in psychiatric and general medical journals. These notes urged physicians to submit reports about lithium babies, normal or abnormal, that might come to their notice. A "lithium baby" was defined as a child born of a woman who had been treated with lithium during the first trimester of pregnancy. Congenital malformations were defined as macroscopic abnormalities of structure attributable to faulty development and present at birth.

Results and discussion

Results:

The study does not allow any conclusion if lithium could cause a high risk with regards to malformations in unborn.

Any other information on results incl. tables

Out of the 118 children reported five were stillborn and seven died within the first week of life; six of these 12 children were malformed. The total number of malformed children was nine. There were two children with Down`s syndrome. Most of the malformations were serious and led to death shortly after birth; the cardiovascular system was involved in six of the nine cases.

The information was collected retrospectively, and one must therefore expect an over-representation of abnormalities among the reports. A lithium baby is more likely to be recognized as such and reported to the Register if it is stillborn or malformed or dies soon after birth than if it is alive and normal in every respect. Little attention has been paid to drugs taken during the pregnancy by mothers of normal and healthy children, whereas the birth of an abnormal child almost certainly leads to inquiries on this point.

Applicant's summary and conclusion

Conclusions:

The authors themselves conclude that retrospective reporting is not a suitable method for detecting an increased risk for developmental defects in lithium-exposed mothers. The retrospective study design as well as the authors' intentions and conclusions disallow any inference into an increased teratogenic potential of lithium in humans.

Executive summary:

In a retrospective study, babies of mothers treated with Lithium carbonate in the first trimester were analysed for the potential malformation to the unborn. The authors concluded that the study does not allow any conclusions if Lithium could cause a high risk with regards to malformations in the unborn.