Registration Dossier

Administrative data

Endpoint:
epidemiological data
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable publication which meets basic scientific principles

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Three common Australian cough mixtures: A study of their use in pregnancy
Author:
Colley DP, Kay J and Gibson GT
Year:
1982
Bibliographic source:
Aust. J. Pharm, 63, 213-217
Reference Type:
publication
Title:
SIDS Initial Assessment Report For SIAM 22
Author:
OECD
Year:
2006
Bibliographic source:
OECD SIDS AMMONIUM BICARBONATE

Materials and methods

Study type:
cohort study (retrospective)
Endpoint addressed:
developmental toxicity / teratogenicity
Test guideline
Qualifier:
no guideline available
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Test substance: Senega and Ammonia mixture Ammonium bicarbonate, liquorice and Senega extracts with chloroform water as preservative

Method

Type of population:
general
Ethical approval:
not specified
Details on study design:
HYPOTHESIS TESTED (if cohort or case control study):
maternal use of three cough preparations including ammonia mixture versus neonatal outcomes

METHOD OF DATA COLLECTION
- Type: Record review
- Details: reevaluation of data set used in former publication by Nelson et al (Br. Med. J., 1971, 1 :523)


STUDY PERIOD: Between January 1978 and November 1980

STUDY POPULATION
- Total population (Total no. of persons in cohort from which the subjects were drawn): 137
- Selection criteria: neonatal outcome in different stages of pregnancy
- Total number of subjects participating in study: 6408
Exposure assessment:
not specified

Results and discussion

Results:
INCIDENCE / CASES
The proportion of adverse neonatal outcomes in relation to maternal use of Senega and Ammonia mixture in pregnancy was as follow::
- Premature birth (before 37 weeks): N = 8; 5.9% (N = 8); control: 6.7% ( N = 421)
- Low birth weight (2500 g or less): 9% (N = 12); control: 6.7% (N= 417)
- Pour Apgar score at 1 min (4 or less): 9.6% (N = 13); control: 6.1% (N=377)
- Congenital abnormalities: 4.4% (N = 6); control: 4.6% (N= 291)
- Perinatal deaths: 0.7% (N = 1); control: 1.5% (N = 94)
- Intrauterine growth retardation: 2.9% (N = 4); control: 1.2% (N = 77)
Strengths and weaknesses:
Although not statistically significant, elevation in the rate for low birth weight and pour Apgar score is observed. An examination of individual cases showed seven (58%) of the low birth weight babies and four (31%) of the pour Apgar score babies were premature (< 37 weeks). The mother of two (50%) of the growth retarded babies smoked more than 20 cigarettes per day. These factors cast doubt on any association with Senega and ammonia mixture.

Any other information on results incl. tables

The absorption of cough medicine containing ammonium bicarbonate during pregnancy is not related to birth abnormalities.

Applicant's summary and conclusion