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Diss Factsheets

Toxicological information

Exposure related observations in humans: other data

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Administrative data

exposure-related observations in humans: other data
Type of information:
experimental study
Adequacy of study:
key study
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Judged as adequate for assessment.
Reason / purpose for cross-reference:
reference to same study

Data source

Reference Type:
Angiotensin-II-receptor inhibitors in pregnancy.
A Hinsberger, A.M Wingen, PF Hoyer
Bibliographic source:
Lancet. 2001; 357 (9268): 1620.

Materials and methods

Type of study / information:
clinical observation
Endpoint addressed:
developmental toxicity / teratogenicity
Principles of method if other than guideline:
no data
GLP compliance:
not specified

Test material

Constituent 1
Reference substance name:
candesartan cilexitil
candesartan cilexitil
Test material form:
not specified
Details on test material:
no data


Ethical approval:
not specified
Details on study design:
no data
Exposure assessment:
Details on exposure:
the mother of the baby (38 y.o.) had been treated with candesartan cilexitil (7 mg per day) for 3 years.
Treatment was stopped 1 day before delivery.

Results and discussion

- The pregnancy was uneventful
- The amount of amniotic fluid was normal during pregnancy, but reduced at term
- In week 39 of gestation, the woman delivered a girl with left-sided facial palsy and plexus paresis, but otherwise seemingly healthy.
- At age 24 h the child was still anuric and serum creatinine was 389 mol/L.
- At day 5, Creatinine rose to a maximum of 530 mol/L; at the same time production of urine started (fraction excretion of sodium 12%), and became normal 6 days later.
- From day 6 to day 28, substitution with sodium hydrochloride and potassium hydrochloride (2 mmol/kg daily of each) was necessary.
- At age 1 month, creatinine had dropped to normal values (27 mol/L).
- Sonography initially showed hyperechogenic kidneys with poor corticomedullary differentiation. The sonographic appearance of the kidneys normalised during the following month.
Plasma renin activity (53·0 ng/mL every hour) and aldosterone (12·6 nmol/L) were very high at day 8. Renin activity was still high at day 35 (52·0 ng/mL
every hour).
- At age 8 months, the girl had developed normally. Plasma renin activity and aldosterone had returned to normal values (3·4 ng/mL every hour and 14
nmol/L, respectively). Only a discrete facial and plexus palsy remained.

Any other information on results incl. tables

no data

Applicant's summary and conclusion

This case is highly suspicious for acute perinatal prerenal failure induced by the angiotensin-II-receptor inhibitor and postnatal hypovolaemia