Ammonium hydrogencarbonate

Epidemiological data

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

Reference

Reference 1

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 2

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

Test material information

Constituent 1

Reference substance name:

Cough mixtures

IUPAC Name:

Cough mixtures

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.