Registration Dossier

Toxicological information

Health surveillance data

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Administrative data

Endpoint:
health surveillance data
Type of information:
other: Case Reports
Adequacy of study:
supporting study
Study period:
1982
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
documentation insufficient for assessment
Remarks:
Data not sufficient for evaluation.

Data source

Reference
Reference Type:
publication
Title:
Lithium-Induced Male Sexual Impaired: Two Case Reports
Author:
Blay, S.L. et al.
Year:
1982
Bibliographic source:
J. Clin. Psychiatry 43:497-498

Materials and methods

Study type:
health record, other
Remarks:
Case reports
Endpoint addressed:
toxicity to reproduction / fertility
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
Constituent 2
Reference substance name:
Lithium carbonate (case report 1)
IUPAC Name:
Lithium carbonate (case report 1)
Constituent 3
Reference substance name:
Lithium compound not specified, most likely Li2CO3 (case report 2)
IUPAC Name:
Lithium compound not specified, most likely Li2CO3 (case report 2)

Method

Type of population:
not specified
Ethical approval:
not specified

Results and discussion

Applicant's summary and conclusion

Conclusions:
Two human case reports exist that led to the notion that lithium could impair male fertility. Male patients (n=2) under lithium therapy (serum levels 18-33 mg/L) complained about reduced libido sexualise and erectile dysfunction. After replacing the lithium by a placebo or after termination of lithium therapy, respectively, recovery of normal sexual functions was reported. This effect is however not surprising as lithium is a psychotropic drug. This effect is therefore not considered as toxic but most likely related secondary to the wished effect of lithium treatment.