Registration Dossier
Registration Dossier
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EC number: 604-138-8 | CAS number: 139481-59-7
Exposure related observations in humans: other data
Administrative data
- Endpoint:
- exposure-related observations in humans: other data
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Judged as adequate for assessment.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- publication
- Title:
- Angiotensin-II-receptor inhibitors in pregnancy.
- Author:
- A Hinsberger, A.M Wingen, PF Hoyer
- Year:
- 2 001
- 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
- Reference substance name:
- candesartan cilexitil
- IUPAC Name:
- candesartan cilexitil
- Test material form:
- not specified
- Details on test material:
- no data
Constituent 1
Method
- Ethical approval:
- not specified
- Details on study design:
- no data
- Exposure assessment:
- measured
- 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
- Results:
- - 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
- Conclusions:
- This case is highly suspicious for acute perinatal prerenal failure induced by the angiotensin-II-receptor inhibitor and postnatal hypovolaemia
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