CAP REPORT NUMBER 9 Drugs and the Third World
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- Title
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CAP
REPORT
NUMBER 9
Drugs and the Third World - extracted text
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CAP
REPORT
NUMBER 9
Drugs and the Third World:
Chloroform
Sale and Hazards
— a Malaysian Study
CONSUMERS' ASSOCIATION OF PENANG
Drugs and the Third World:
Chloroform
Sale and Hazards
— a Malaysian Study
CONSUMERS' ASSOCIATION OF PENANG
Published by
Consumers1 Association of Penang
87 Cantonment Road,
Penang, Malaysia.
The Consumers’ Association of Penang is a voluntary
non-profit organisation which fights for the rights
and interests of all consumers through research,
educational and representational activities.
Printed by
Sun Printers Sdn Bhd
78 Church Street,
Penang, Malaysia.
Copyright (c) Consumers’ Association of Penang 1986
ISBN 967-9950-24-7
CONTENTS
3
Preface
Chapter
1
Introduction
Chapter
9
2
Chloroform: INN (International Non-
11
proprietary Name Selected by WHO)
(1)
Actions
(2)
Adverse Drug Reactions
(3)
Potential Carcinogenicity of Chloroform
(4)
Chloroform in Cough Mixtures
Chapter
3
Regulations Concerning Chloroform Worldwide
Chapter
4
Drug Information and Brands Sold in Malaysia
(1)
Information in DIMS
(2)
Warnings and Contraindications:
Inadequate Information
(3)
Indications Given
(4)
Chloroform Preparations not Listed in DIMS
(a)
Dosage instructions for Woods’ Great
Peppermint Cure
(b)
17
Dosage instructions for Boon’s Cough
Remedy
22
(c)
Dosage instructions for Breacol Cough
Syrup
Chapter
5
Advertising and Promotion of Chloroform
^9
Preparations in Malaysia
(1)
Advertisements
(2)
Package Inserts
Chapter 6
Chloroform as an Occupational Hazard
47
(1) Case Report I
(2) Case Report II
(3)
Discussion of the Above Findings
Chapter 7
Conclusion
References
Appendix 1
52
54
Dosage Instructions for Woods’ Great
56
Peppermint Cure
Appendix 2
Dosage Instructions for Boon’s Cough Remedy
57
Appendix 3
Dosage Instructions for Breacol Cough Syrup
58
Appendix 4
Package Insert for Kwan Loong Medicated Oil
59
Appendix 5
Package Insert for Tiger Oil
60
Appendix 6
Package Insert for Gold Fish Medicated Oil
61
PREFACE
Chloroform is a highly potent and dangerous anaesthetic.
It is known to cause severe liver damage and may even
cause cancer. According to Vickers’ Drugs in Anaesthetic
Practice, ’The major disadvantage of chloroform is its
effect on the liver, as severe liver damage can follow
short exposures’
(Vickers, et al, 1979: 140).
Despite all the documented evidence of its dangers, chlo
roform is present as a component in many products market
ed in Malaysia.
Under the Malaysian Poisons Ordinance 1952 and the Poisons
List 1983, chloroform in strengths of 10% and above is
listed as a Group C Poison. This means that it cannot be
sold or supplied by retail to any person. It can only be
dispensed by a medical practitioner on prescription.
For strengths of below 10%, however, chloroform is exempt
from the above restriction. As a result, many products on
sale in Malaysia contain chloroform. Among the products
are cough medicines, which are used by both children and
adults.
In a number of other countries, the use and sale of chlo
3
roform have been totally banned or severely restricted.
Some of these countries are Belgium, Canada, the Federal
Republic of Germany, Italy, Japan, New Zealand, Norway,
the Philippines and Saudi Arabia.
In the US, claims about the usefulness of chloroform in
cough mixtures have been refuted. A 1973 editorial in the
Journal of the American Medical Association stated that
’there is a paucity of experimental evidence to support
the claims made for the expectorant constituents of cough
mixtures. Sodium citrate, citric acid, chloroform ... do
not increase sputum volume, render mucous less viscous,
or otherwise change bronchial secretions when administered
in the doses present in antitussive (cough) mixtures’.
In the same year, a National Academy of Sciences National
Research Council Committee reviewing the efficacy of cough
medicines found that Benylin, a very popular chloroform
containing cough medicine in the US by Parke Davis, was
’ineffective’ (Federal Register 9 Feb 1973). Parke Davis
has now removed chloroform from Benylin.
On 30 December 1975, Dr Sidney M Wolfe of the US Health
Research Group wrote to the Commissioner of the US FDA,
urging for the ban of chloroform in all products. Dr Wolfe
said that ’in terms of efficaciousness, there is no justi
fication for chloroform to be included in cough medicines’
and ’since there is no evidence that the presence of
chloroform in cough syrups offers any benefits, its elimi
4
nation from the products does not require replacement by
another chemical’ (Ibid).
The fact that the use of chloroform is still allowed in
Malaysia shows a clear need for more adequate health
regulations in this country. The laxity in health regula
tions has given free rein to pharmaceutical companies
in the promotion and advertising of their products, many
of which are aimed specifically at children.
The companies do not provide complete or clear instructions
for the use of their products, nor any warning about the
dangers of chloroform. Moreover, they tend to exaggerate
the efficacy of their products, recommending them for a
large number of ailments ranging from coughs and colds to
rheumatism.
In Malaysia, doctors and pharmacists get information on
chloroform and drug preparations containing chloroform
from three main sources:
•
the Drug Index for Malaysia and Singapore (DIMS) , which
is given free to doctors
•
drug advertisements and brochures, distributed free to
doctors by sales representatives of the drug companies
•
drug inserts, packages and labels, which come together
with the products purchased
It should be noted that all the above sources are prepared
by the pharmaceutical companies. Therefore, there is a
5
possibility that doctors are prescribing drug prepara
tions containing chloroform to their patients without
realising the possible adverse side effects that could
arise.
What is definite is that many consumers themselves are
purchasing chloroform-containing products over the counter
in drugstores, supermarkets, etc. and using them without
being aware of the dangers of chloroform.
Experiments with animals have shown that chloroform is a
potential carcinogen. This was confirmed by a study done
by the US National Cancer Institute. Based on such evidence
the US FDA in 1976 announced its intention to prohibit the
use of chloroform as an ingredient in drugs and cosmetic
products and as a food additive.
The FDA stated that ’a clear demonstration that a compound
is carcinogenic in experimental animals must be taken as
evidence that it has the potential for carcinogenesis in
humans ...’ (WHO DIB October 1976: 13).
Pharmaceutical manufacturers were then given notice to
remove chloroform from all products, including traditional
cough preparations, liniments and toothpastes, as soon as
possible (Ibid).
Chloroform has also proved to be an occupational hazard,
as revealed in a report in the Medical Journal of Malaysia
6
Vol 38 No 1 March 1983. According to the report, what was
originally suspected to be an outbreak of viral hepatitis
among workers in two factories in Singapore was later
diagnosed as an outbreak of toxic hepatitis, the result
of chemical exposure to chloroform.
All the facts presented in this report show that the use
of chloroform in products like drug preparations should
not be allowed at all. As stated by Vickers, ’Because of
the danger of liver damage, and in spite of its cheapness,
acceptable odour, non-inflammability and useful anaesthetic
properties, there appears to be no indications for the
use of chloroform when safer and equally effective agents
are available’ (Vickers, et al, 1979: 140).
CAP therefore strongly urges the Ministry of Health to act
immediately to ban the use of chloroform in all products,
so as to ensure the good health of all Malaysian consumers,
including children.
I would like to thank Evelyne Hong and Shila Rani Ranjit
Kaur for the research and the writing of this report.
S M Mohd Idris, JP
President
Consumers’ Association of Penang
1986
7
CHAPTER 1
INTRODUCTION
Chloroform has acquired a fearsome reputation as a high
ly potent and highly dangerous anaesthetic with a liabi
lity to cause death due to vagal (pertaining to the vagus
nerve) cardiac arrest and to ventricular fibrillation
(convulsive movements of the ventricles of the heart)
while it is being administered. Much of this reputation
could be ascribed to the uncontrolled administration of
excessive inhaled concentration of chloroform to unpre
pared, hypoxic (suffering from a deficiency of oxygen in
inhaled air) and hypercarbic (having excessive carbon
dioxide in the blood) patients. Chloroform has more cardiac
irritant properties than most other inhalation agents. It
is a respiratory depressant (a medicine which reduces
respiratory activity and the vital energies in general
by producing muscular relaxation) (Vickers, et al, 1979:
140) .
The major disadvantage of chloroform is its effect on the
liver; severe liver damage can follow short exposures to
the compound. In so-called delayed chloroform poisoning the
effects of chloroform appear 24-48 hours after administra
tion. There is centrilobular necrosis (death of the central
9
portion of a lobule of the liver), which in severe cases
may become massive. This form of liver damage is said to
be more likely to occur in starved, dehydrated and toxic
patients or in those repeatedly exposed to chloroform
(Ibid).
This report by the Consumers’ Association of Penang
urges the Ministry of Health to immediately review the
benefit of this compound, bearing in mind the deleterious
effects of the compound and hence its toxicity, and to
impose a ban on its use in products. At present chloroform
in strengths of 10% and above is listed as a Group C Poison
which means that it cannot be sold or supplied by retail to
any person. It can only be dispensed by a medical practi
tioner on prescription. However there is no restriction on
the use of chloroform in strengths of below 0.25%. And in
strengths of 0.25-9.99%, chloroform is listed as a Group E
Poison, with retail sale restricted to licensed pharmacists
and labelling requirements only. This lax Malaysian health
regulation has given rise to a situation where many prepa
rations containing chloroform can be purchased over the
counter, which should not be the case because of the toxi
city of the compound.
10
CHAPTER 2
CHLOROFORM: INN (International Nonproprietary Name
Selected By WHO)
(1)
Actions
Chloroform has a characteristic odour and a sweet burning
taste (Martindale 28th ed: 693). It is a potent anaesthetic
and possesses good analgesic and muscle relaxant properties
as well (Ibid).
Because of the danger of liver damage, and in spite of its
cheapness, acceptable odour, non-inflammability and useful
anaesthetic properties, there appears to be no indications
for the use of chloroform when safer and equally effective
agents are available (Vickers, et al, 1979: 140).
(2)
Adverse Drug Reactions
Chloroform is hepatotoxic (causing liver damage) and
nephrotoxic (causing kidney damage). It depresses respi
ration and produces hypotension (low blood pressure)
(Martindale 28th ed: 693). It may take six to 24 hours
after a dose before appearance of delayed symptoms charac
terised by abdominal pain, vomiting, and at a later stage,
11
jaundice (Ibid).
In mice, chloroform produces liver damage in both sexes.
It was found that chloroform did not develop renal tribular
necrosis (death of cellular material or of a section of
tissue due to irreversible injury to nuclear structure) in
female and castrated male mice (Ahmadizadeh, et al, 1984:
161-72).
Results of several experiments with mice have suggested
that the incidence and severity of the nephrotoxicity
caused by chloroform varies according to the species,
strain and sex of each animal (Pohl, et al, 1984 Vol 12
No 3: 304-8).
(3)
Potential Carcinogenicity of Chloroform
The earliest evidence which suggested that chloroform was
cancer-causing was found in experiments conducted by
Eschenbrenner and Miller in 1945. They discovered that
liver tumours were found in animals given 30 oral doses
of a chloroform-containing solution (Eschenbrenner, et *al,
1945 Vol 5: 251-5). A few years later, as a result of a
series of experiments using small numbers of animals,
another researcher also suggested the liver tumour
producing properties of chloroform (UICC Monograph Series
1967, Vol 7: 135).
In 1972, the International Agency for Research on Cancer
12
(IARC) in Lyon, in a review of the question of chloroform
carcinogenicity, stated that: ’The carcinogenicity of
chloroform has been investigated only in mice ... Never
theless, among these the frequency of liver tumours was
high ...’ (IARC Monographs 1972 Vol 1: 61-5).
Shortly after this review, the US National Cancer Institute
(NCI) initiated a feeding study of the carcinogenicity of
chloroform in mice and in rats (Public Citizen 30 Dec 1975).
On 19 November 1975, at a meeting of the US Environmental
Protection Agency (EPA), Hazardous Materials Advisory
Committee, it was stated that ’the NCI Study has confirmed
the carcinogenicity of chloroform’ (Ibid). The NCI study
found tumours in both mice and rats, with liver cancer
in mice and kidney tumours in rats (National Cancer
Institute 1976). While chloroform has long been known to
cause liver damage, this study has now confirmed the long-
held suspicion that the drug can also cause cancer (Ibid).
On 9 April 1976, the US Food and Drug Administration (FDA)
gave notice in the Federal Register of its intention to
prohibit the use of chloroform as an ingredient in drugs
and cosmetic products and as a food additive. The FDA in
formulating its decision stated that ’a clear demonstration
that a compound is carcinogenic in experimental animals
must be taken as evidence that it has the. potential for.
carcinogenesis in humans unless there is strong evidence
to the contrary (WHO DIB October 1976: 13). Pharmaceutical
13
manufacturers were given notice to remove chloroform from
all products, including traditional cough preparations,
liniments and toothpastes, as soon as possible (Ibid).
In mice and rats, chloroform has also been found to be
teratogenic (causing birth defects). However it is because
of the carcinogenicity (ability to cause cancer) of the
compound that its use in pharmacy has been recommended
to be discontinued and the maximum permissible level of
industrial exposure has been drastically lowered to 10 mg/
3
m of inhaled air (National Institute for Occupational
Safety and Health).
An average man under conditions of moderate exertion will
3
breathe m about 10m of air in an eight-hour working day.
At the maximum recommended level of exposure given above,
the total amount of chloroform to which his body would be
exposed via inhalation would be 100 mg per day although
not all of this would necessarily be absorbed (Ibid).
(4)
Chloroform in Cough Mixtures
Chloroform is commonly used as an ingredient in cough
mixtures. It is claimed that the compound increases
sputum volume and renders mucous less viscous (sticky).
However, according to a 1973 editorial in the Journal of
the American Medical Association, ’there is a paucity of
experimental evidence to support the claims made for the
14
expectorant constituents of cough mixtures. Sodium citrate,
citric acid, chloroform ... do not increase sputum volume,
render mucous less viscous, or otherwise change bronchial
secretions when administered in the doses present in anti-
tussive (cough) mixtures’ {Journal of the American Medical
Association 1973 Vol 224: 621).
In the same year, a National Academy of Sciences National
Research Council Committee reviewing the efficacy of
cough medicines found that Benylin, a very popular cough
medicine in the US by Parke Davis, was ’ineffective’, that
is, it lacked any evidence of efficacy {Federal Register
9 Feb 1973). Parke Davis has now removed chloroform as an
ingredient in Benylin.
In his letter on 30 December 1975 to the Commissioner of
the US FDA urging for the ban of chloroform in all products,
Dr Sidney M Wolfe of the US Health Research Group said that
’in terms of efficaciousness, there is no justification
for chloroform to be included in cough medicines’ and ’since
there is no evidence that the presence of chloroform in
cough syrups offers any benefits, its elimination from the
products does not require replacement by another chemical’
(Ibid).
It is recommended that persons with liver dysfunction,
alcoholics, drug addicts, pregnant women and nursing
mothers should not be exposed to even low levels of
chloroform (Ibid).
15
Chloroform is also contained in toothpaste, liniments
salves and hair-tinting preparations (Ibid) .
16
CHAPTER 3
REGULATIONS CONCERNING CHLOROFORM WORLDWIDE
Chloroform has been removed from most marketed drugs inclu
ding cough preparations, liniments and toothpastes in the
countries listed below (Consolidated List of Products 1983).
However, many of these countries’ regulations are meant for
products entering domestic national markets; they do not
necessarily extend to products destined for eiq)ort. Hence
proprietary medicines containing chloroform which are
locally banned in some countries can still be exported
(WHO DIB Oct-Dec 1979: 6).
Canada
As of January 1978 the National Legislation has provided
that no manufacturer or importer shall sell for human use
a drug that contains chloroform as an ingredient. The
Health Protection Branch has reviewed evidence from the
National Cancer Institute in the US which suggests that
chloroform may be carcinogenic in rats and mice when
administered in high doses over prolonged periods. Export
of this product is allowed with no requirement of foreign
notification regarding domestic restrictions on its use.
17
Federal Republic of Germany
Here chloroform is prohibited for use and/or sale.
Denmark
Chloroform is registered only for veterinary use in
Denmark from 1981.
Dominican Republic
From 1983, domestic manufacturers and importers have been
requested to eliminate this ingredient from their marketed
products since pharmacological studies have shown it to be
toxic to the liver and the heart and to be carcinogenic.
United Kingdom
Since 1979, the Chloroform Prohibition Order has banned the
sale or supply of any medicinal product containing chloro
form. However certain exemptions still do apply in the
United Kingdom.
Then, as from 28 March 1980, the sale or supply of any
medicinal product consisting of, or containing, chloroform
was prohibited in the United Kingdom (WHO DIB Jan-March
1979: 19). However a maximum concentration of 0.5% of
chloroform content in all formulations is still allowable
and a number of exemptions are even made for toothpaste,
18
anaesthetics, other products used in dental surgery,
medicines dispensed for specified individuals against
a prescription, and preparations intended for external
applications (Department of Health and Social Security,
UK, The Medicines (Chloroform Prohibition) Order SI 1979:
382).
Italy
As of 1978, chloroform has been withdrawn from the market
owing to suspected carcinogenicity.
Japan
In Japan, since 1976, chloroform has been banned by the
Pharmaceuticals Affairs Bureau in drugs and cosmetics for
reasons of carcinogenicity. However export of chloroform
is allowed with no requirement of foreign notification
regarding domestic restrictions on use.
Norway
As of April 1978, chloroform has been prohibited for use
in pure form or as an additive to pharmaceutical prepara
tions in Norway.
New .Zealand
From 1980, all toothpaste formulations containing chloro-
19
form have been voluntarily withdrawn from the market in
New Zealand.
Philippines
As of April 1978, chloroform has been prohibited for use
as an ingredient in human drugs and cosmetics by Adminis
trative Order No 34 in the Philippines.
Saudi Arabia
As of 1977, sale or supply of any medicinal product
containing chloroform has been prohibited by the Drug
Corqni tree in Saudi Arabia.
Turkey
As of 1976, chloroform has- been removed from all cough
syrups following a decision by the Ministry of Health
based on a review of published information regarding
carcinogenicity in rats. Export of this product has also
been prohibited.
Venezuela
In Venezuela, chloroform is subject to restricted use and/
or sale.
20
Belgium
The Ministry of Public Health and Family Affairs of Belgium
has withdrawn all products containing chloroform intended
for systemic use on the grounds of lack of efficacy, and
because of the carcinogenic potential and toxicity of this
substance (WHO DIB April-June 1984).
Malaysia
In contrast, the Malaysian health regulation on chloroform
is lax.
Under the Poisons Ordinance 1952 and the Poisons List 1983,
chloroform is listed as a Group C Poison for strengths of
10% and over. A Group C Poison cannot be sold or supplied
by retail to any person. It can only be dispensed by a
registered medical practitioner, registered dentist
Division I or veterinary surgeon, or by a licensed pharma
cist, as a dispensed medicine on and in accordance with a
prescription written out by a registered medical practi
tioner, registered dentist or veterinary surgeon.
However, there is no such restriction on chloroform in
strengths under 10%. Hence, it is present as an ingredient
in many products on the market.
21
CHAPTER 4
DRUG INFORMATION AND BRANDS SOLD IN MALAYSIA
In Malaysia, doctors and pharmacists obtain information
on chloroform from three major sources. They are:
a)
The Drug Index for Malaysia and Singapore (DIMS) .
DIMS is a quarterly publication on ethical medicines
available in Malaysia and Singapore. It is prepared
by the pharmaceutical companies and distributed free
to doctors in both countries.
b)
Drug advertisements and brochures which are distribu
ted free to doctors by drug company retailmen.
c)
Drug inserts, packages and labels which come together
with the drugs when they are purchased. These give, or
should give, information on the use of the drugs, the
dangers and the precautions to be taken when the drug
is used. The instructions and information on the drug
are provided by the company which markets its parti
cular brand product.
By referring to DIMS and by examining the package inserts
of the various chloroform products published by the
22
pharmaceutical industry, it was found that the information
provided was inadequate. Not enough was said about the
dangers of chloroform to children as well as adults. There
were no indications as to its toxicity and its ability to
cause liver damage.
(1)
Information in DIMS
Chloroform is not listed in the generic names register in
DIMS. Hence, not all preparations containing chloroform
can be traced. However, three preparations of ’Cough and
Cold Remedies’ containing chloroform are found in DIMS
(Vol 14 No 2, June 1985: 93-4).
They are:
* Cofnil
* Diphendryl/Diphendryl CP
* Diphenmine
Diphendryl/Diphendryl CP and Diphenmine are both Group C
Poisons.
The manufacturers of the three chloroform preparations,
together with their contents, are listed in Table 1.
23
Under the notes on Symp a th omi metics, information is
provided as follows:
1 Contra-Indications:
Idiosyncrasies to sympathomimetics ,
hyperthyroidism, hypertension and coronary disease.
Sympathomimetics should not be used concomitantly with
nor within 2 weeks of MAO Inhibitor therapy.
Special Precautions:
Caution in cardiac disease and
diabetes, and in pregnancy as uterine contractions may be
inhibited. ’
There is no single mention of chloroform and warning
against its toxicity.
(3)
Indications Given
Apart from the complete absence of information on chloro
form, the indications for the three drugs are as follows:
COFNIL CD - Pharmmalaysia
’Indications:
C/I & S/P:
Cough suppressant
See notes 2 & 3 section 3c of DIMS, Vol 14 No
2 June 1985.’
26
DIPHENDRYL/DIPHENDRYL CP - Asia Pharm
’Indications:
Cough and upper respiratory congestion and/
or dry and irritating cough in CP.
C/I & S/P:
See notes 1 & 3 section 3c.’
DIPHENMINE - Camden
’Indications:
Control of cough and alleviation of nasal
stuffiness, sneezing, lachrymation and
bronchial congestion.
C/I & S/P:
(4)
See notes 1 section 3c.’
Chloroform Preparations not Listed in DIMS
Other cough and cold remedies and local medicines not
listed in DIMS and containing chloroform are available
over-the-counter in sundry shops, supermarkets and
medicinal halls all over the country. CAP obtained:
* Breacol Cough Syrup (Sterling)
* Woods’ Great Peppermint Cure (Woods)
* Boon’s Cough Remedy (Boon Pharmacy)
* Minyal Angin Cap Singa Kwan Loong (Hudson Malaysia Sdn Bhd)
* Tiger Oil
* Minyal Angin Cap Ikan Mas (Ban Choon Tong Sdn Bhd)
t In a market survey in September 1986, CAP noted that chloroform was no longer listed
in the contents of Woods’ cough medicine. According to a company official that CAP
contacted, Woods had removed chloroform from its cough medicine as of April 1986.
However, CAP found that some of the old preparation containing chloroform
were still on sale. In this report, study on Woods’ cough medicine is based on the
original formula.
27
Products containing chloroform, found on the market
SAIZ POCKET
ME
SAKIT ME PAIA
StlSEWA PlfAM
SAKIT PEAUT. OAH
[Alt IAIM DiSAPU
8AGI 5IMUA OAAWG
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|
The products, together with their manufacturers and
contents, are listed in the table below.
Table 2:
Chloroform Preparations not Listed in DIMS
Source:
CAP survey
Brand Name
Manufacturer
1
Contents
1)
Boon’s Cough
Remedy
Boon Pharmacy
Chlorodyne
1.24
Tr. Ipecae
4.69
Tr. Scillae
2.105
Syr. Tolu
Q.S.
Inf. Senegae
Cone.
4.69
Spt.Chloroform 0.62
Aq.Chloroform add 100
2)
Woods’ Great
Peppermint
Cure
Woods
Acid Benzoic
0.46
Aether
0.14
Camph.
0.0067
Chlorof.
1.07
Glycer
0.85
01. Anis
0.0067
01. Menth. Pip 0.90
Pot. Nitras
6.54
Alcohol
5.00
3)
Breacol Cough
Syrup
Sterling
Extract White
Pine Comp.
FE Horehound
Glucose
Liquid
Menthol
Chloroform
Oil Pine Tar
Soluble
Saccharin
32
1.102 gm
0.521 ml
92.51 gm
0.068 gm
0.416 ml
0.033 ml
0.003 gm
Brand Name
Manufacturer
Contents
Caramel1.5
ml
Ammonium
Chloride
1.26 gm
Honey
4.375 ml
Oil Eucalyptus 0.13 ml
XYLOPOL, Brand
of HexylDihydroxybenzene
0.1
gm
Purified water,
q.s. ad
100
ml
4)
Minyak Angin
Cap Singa
Kwan Loong
5)
Tiger Oil
6)
Minyak Angin
Cap Ikan Mas
Hudson
Malaysia Sdn
Bhd
Menthol Crystal 25%
Camphor Powder 10%
Chloroform B.P. 0.5%
Oil Lavender
Spike
7%
Methyl
Salicylate
15%
Eucalyptus Oil 10%
32.5%
White Oil
Menthol
Methyl
Salicylate
Camphor
Eucalyptus Oil
White Oil
Lavender Spike
Chloroform
Ban Choon Tong
Sdn Bhd
33
8.00%
38.00%
17.50%
6.00%
25.00%
5.00%
0.50%
Menthol Crystal 28.5%
Methyl
Salicylate
12.0%
Chloroform
3.0%
White Oil Q.S.ad 100%
Camphor
5.1%
Eucalyptus Oil
4.7%
Lavender Oil
4.5%
Some advertisements for
chloroform products that
have appeared in local news
papers and periodicals
Stop it with Breacol,
the family cough medicine.
Many of these preparations are widely advertised in our
local newspapers and periodicals.
They are very popular
and are used by children and adults.
Some users
interviewed by CAP said that the preparations were very
effective and cheap.
Chloroform has been proven to cause liver damage.
If
cough mixtures containing this substance continue to be
administered to children from a very tender age, the
long-term effects may prove to be fatal.
Yet the preparations CAP came across are meant for
children as well as adults.
Below are examples of
dosage instructions for children.
(a)
Dosage instructions for Woods1 Great Peppermint Cure
(See Appendix 1)
The instructions on the box are written in English, Chinese
Malay and Tamil.
The dosages for children are:
from 10 - 15 years of age, half a teaspoonful
from
5-10 years of age, fifteen drops
for
5 years and under, five drops
There are no instructions as to how often the cough mixture
should be administered to children.
The dosage for adults
is one teaspoonful four or five times a day.
35
From the formula given on the bottle label, it was
calculated that every 15ml of the cough syrup would
contain about 7% of chloroform.
concentration indeed.
This is quite a strong
Giving chloroform to children in
such high doses is extremely dangerous.
(b)
Dosage instructions for Boon's Cough Remedy
(See Appendix 2)
The instructions on the box are given in English, Chinese
and Malay.
The dosages for children are:
one dessert-spoonful for 10- to 16-year-olds
one teaspoonful
for
6- to 10-year-olds and
half a teaspoonful
for
3- to
6-year-olds
Here too, there are no instructions as to how often the
cough mixture should be administered to children.
The
dosage for adults is one tablespoonful every 3-4 hours.
(c)
Dosage instructions for Breacol Cough Syrup
(See Appendix 3)
The instructions on the box are written in English,
Chinese and Malay.
The dosages for children are:
12-year-olds
2/3 teaspoonful
8-year-olds
1/2 teaspoonful
5-year-olds
1/3 teaspoonful
Infants
5 to 10 drops every 3 or 4 hours
The dosage for adults is 1 teaspoonful every 3 or 4 hours.
36
It should be noted that all the dosage instructions are
not very clear, and in certain cases may give rise to
confusion as to how much of the preparation should be
given to a child.
When the chloroform issue was brought up in Malaysia in
November 1976, the Minister of Health at the time,
Tan Sri Lee Siok Yew, stated that The Poisons Board of his
Ministry was conducting a study to find out whether the
use of chloroform in drugs and cosmetics posed health
He added that further action on the use of the
hazards.
chemical would be taken after receiving the recommendations
of the Board.
In 1977 The Poisons Board recommended to the Ministry of
Health that the use of chloroform in preparations be
retained.
Chloroform in strengths of 10Z or over in
preparations should remain unchanged and be classified
as Part I - Group C Poisons; preparations which contain
chloroform in strengths of O.25Z - 9.99Z should be
classified as Group E Poisons and there should be no
restriction on the use of chloroform for strengths below
O.25Z.
The Board’s ’contention is that chloroform is
widely used as preservative in strengths of below O.25Z’.
The Poisons Board also added that, ’pending receipt of
a fuller report from FDA, Washington, our recommendation
can be further reviewed if necessary’.
The FDA had
removed all chloroform from pharmaceutical preparations
since 1976 (Berita Farmasi, Vol 4 No 2 Feb 1977: 27).
37
Nine years have passed since then and no action has been
forthcoming from the Health Ministry.
Products containing
chloroform, such as cough and cold mixtures, continue to be
sold in Malaysia.
The Ministry of Health must halt the drug companies’
dumping of products containing chloroform that have been
banned elsewhere.
It should also warn local manufacturers
to remove chloroform from all their products immediately.
38
CHAPTER 5
ADVERTISING AND PROMOTION OF CHLOROFORM PREPARATIONS IN
MALAYSIA
Generally, the advertisements and package inserts of the
preparations make highly exaggerated claims about the
properties and effectiveness of the products.
In many
cases, the advertisements make use of children to sell
the products, giving the idea that the products are ideal
for the whole family, including the children.
(1)
Advertisements
In March 1980, four advertisements of Kwan Loong
Medicated Oil appeared in the New Straits Times. The
product was advertised with the four virtues of
Honesty, Trust, Wisdom and Strength written in Chinese
characters.
At the end of each of the advertisements was
stated ’Honest in claims and effectiveness’, ’Trusted by
generations’, ’A product of wisdom, trusted by the wise’
and ’Strong and gentle, a friend indeed’ respectively.
The aim here is to give an air of reliability to the
product.
In December 1985, another advertisement for Kwan Loong
Medicated Oil appeared in the Star. It was advertised as
39
fr>r Kwan Loong Medicated Oil
Another advertisement for Kwan Loong Medicated Oil
The popularfavourite
that has been easing
coughs and colds
for more than 80 years.
follows: 'When it comes to you and your family's good
health, your first thought for an effective and trustworthy
medicated oil is Kwan Loong ... It is worth the price you
pay ... Good value down to the very last drop.'
The New Straits Times (31/3/81) carried an advertisement
on Woods' Great Peppermint Cure that said, in large, bold
print: 'The popular favourite that has been easing coughs
and colds for more than 80 years'.
The statement implies
that since the preparation has been available for such a
long period of time, it has to be safe and good for use.
In other words, the statement lends an air of respectability
and dependability to the product.
In October 1985, the Sarawak Tribune carried an
advertisement on Woods’ Great Peppermint Cure Children's
Cough Syrup that said: 'Just for little ones like us'.
After this was stated: 'Little ones need special care.
And Woods' know how.
Woods' Great Peppermint Cure
Children’s Cough Syrup is specially formulated for little
ones.
It's pleasant tasting.
Very soothing.
relieve coughs, even colds and sore throats.
And helps
Woods'
Children's Cough Syrup works fast and is effective.
No
wonder it's the great family solution trusted for
generations .'
Right next to these words is a picture of three smiling
children.
This is an example of an advertisement that is
aimed primarily at children.
43
Advertisement for Breacol Cough Syrup
Stop it with Breacoi,
the family cough medfcme.
Breacol fights coughs
5 ways.
1.
Contains a special ingrerkent.
XYLOPOL. that stops the action of
coughcausing germs.
2.
Cod. mentholated flavour soothes
rotation of throat and Logs.
3.
Rebeves throat tickle.
4.
Helps dear choking pheigm
5.
Eases the urge to cough.
Hus. Breacoi contains glucose to give
you energy.
Breacoi works eflectrvety for adufts. And
it s ideal for chddren too* Just make sure
you foGow dosage nstructions carefdty.
Breacoi. The proven cough medicine that
works 5 ways to provide more effective
rebef from coughs.
ideal for children and adults.
Breacol
Stops coughs 5 ways.
KXU U. 0O6OT8 J/AflOG
The advertisement for Breacol cough syrup (Borneo Bulletin,
4/2/84) shows a picture of a family - father, mother and
son - playing together happily.
The idea here is also to
convey the message that the product is suitable for the
whole family, that it takes care of the whole family’s
health and that it contributes to the family’s happiness.
This is reinforced by describing Breacol as a ’family
cough medicine’ that is ’ideal for children and adults’*
(2)
Package Inserts
The popular local liniment Kwan Loong Medicated Oil
(zninyak angin or commonly known as ’ Ipoh Oil’), which
contains 0.5% chloroform, is recommended in the insert
’for all external ailments and as a first aid in emergencies*
It is an unfailing preventive against influenza and other
contagious diseases.
Miners, planters, tourists, business
men and athletes will find it handy and indispensable’
(See Appendix 4).
The liniment is recommended for such ailments as sprains,
rheumatism, chest complaints, sores, bruises, cuts,
toothache and fainting fits.
In the case of Tiger Oil, the information insert states
that it is ’manufactured by the most up-to-date
pharmaceutical processes.
Its production is carefully
controlled at all stages by skilled pharmacists and
45
chemists to give a product of the highest quality’ (See
Appendix 5).
Exactly what the ’up-to-date pharmaceutical processes’ are
is left to the imagination.
And the phrase ’... product
of the highest quality’ is used to imply that the product
is really good and reliable.
The product is said to be ’a time-tested and effective
household remedy’ for the symptomatic relief of headache,
stomachache, colds, coughs, giddiness, overwork, mental
tiredness, insect bites, travelling sickness and
rheumatism.
The information insert for Gold Fish Medicated Oil (See
Appendix 6) states the following: ’This Medicated Oil is
essential for everybody. It has many effective use.
A
few drops will do you miracles ... It is pleasant in
taste and entirely free from harmful substances ... and is
suitable for use by both adults and children.’
Ailments for which this product is recommended range from
influenza and sinusitis to overwork and rheumatism.
The claim that ’a few drops (of the medicated oil) will
do you miracles’ is obviously an exaggeration, typical of
the claims frequently made by the advertisements and package
inserts of the chloroform preparations on sale in Malaysia.
46
CHAPTER 6
CHLOROFORM AS AN OCCUPATIONAL HAZARD
Below are reports of complications associated with the
use of the drug, chloroform, as cited from the Medical
Journal of Malaysia (Vol 38 No 1 March 1983:31-4).
(1)
Case Report I
Between October 1973 and July 1974, 13 workers from a
large factory in Singapore were diagnosed by their
doctors as having viral hepatitis.
Except for two, all
had symptoms of anorexia (lack or loss of the appetite
for food), nausea and vomiting.
The other two who had
no symptoms had been noticed by their colleagues to be
jaundiced.
All 13 were jaundiced when seen by the doctors.
It was found that all 13 came from one section of the
factory.
Past medical histories for all were negative.
In this particular department, work was mainly mechanical,
related to the sub-assembly of electrical toasters.
No
chemical was being used except a degreasing agent on the
contact welding machines.
This agent was found to contain
99.5% chloroform and 0.5% ethyl alcohol.
47
The level of chloroform vapour in the air was found to be
more than 440ppm (upper limit of the range measurable on
detector tubes).
analysed.
Blood samples of workers were taken and
Blood chloroform levels between 0.10 and O.29mg
per 100ml were found in these workers.
(2)
Case Report II
Between May and August 1980, 11 cases of acute infectious
hepatitis were reported in another factory in Singapore.
This one produced radio cassette recorders and digital
clock radios.
No Hepatitis B surface antigen (virus causing hepatitis)
was found, showing that the factor responsible for the
outbreak could not be the hepatitis virus.
It was first thought that contaminated drink from a
vending machine was the vehicle of transmission.
However between November 1980 and October 1981, five more
cases of infectious hepatitis were reported from this
factory. Since all the cases reported came from the same
department of the factory and a chemical smell was detected
in the workroom, chemical intoxication was suspected.
The
matter was then referred to the Industrial Health Division
of the Ministry of Labour in October- 1981 for further
inves ti gation.
48
(Besides these 16 hepatitis cases reported, it was later
discovered that there had been two more cases from the
same factory.
One victim was hospitalised in May 1980
and the other in October 1980.)
The hepatitis cases were found to be from the Casing
Department.
Here there were five assembly lines where
components were assembled, encased and packed for export.
Chloroform was used as an adhesive.
It was either
squeezed out from a small plastic bottle or poured out
onto a small open dish and applied with a brush.
When
chloroform was applied to the plastic casing or to other
components, it melted the plastic.
The various components
Whenever more chloroform
could then be stuck together.
was required, it was poured from a tin containing chloroform
in one part of the room, into the dishes or small bottles
for the operators on the assembly lines.
An assessment of chloroform vapour in the air of the
workroom was made on two occasions.
On 14 December 1981,
spot tests using a portable infrared gas analyser detected
between 14.4 and 33.3 ppm of chloroform.
On 22 December
1981, gas chromatographic analysis by the Department of
Scientific Services showed levels of between 19.6 ppm
and 50.4 ppm.
The threshold limit value (TLV) of chloroform was 10 ppm
(TLV refers to that degree of concentration of a substance
in the blood plasma above which the substance is excreted
49
by the kidneys and below which it is not excreted) .
(3)
Discussion of the Above Findings
The two outbreaks of toxic jaundice described showed
similar features.
They were traced to occupational
exposure to chloroform, a known hepatotoxic agent.
In
both outbreaks, the workers affected had been exposed to
the chemical for less than six months.
All the cases were originally diagnosed as having viral
hepatitis, a common cause of jaundice.
But the diagnosis
of toxic hepatitis was made retrospectively based on
epidemiological evidence.
Occupational exposure to high
levels of chloroform vapour was confirmed.
The signs and symptoms of toxic hepatitis from chloroform
exposure were similar to those of viral hepatitis.
The
latter condition is often a presumptive diagnosis made on
clinical grounds, especially for type A disease, although
a positive test for hepatitis B surface antigen would
identify hepatitis B disease.
However, viral hepatitis is
usually associated with fever, at least initially.
But of
the B cases of toxic jaundice in the first outbreak
described, none of the victims gave a history of fever.
In the second outbreak, only four of the 18 victims had
given a history of fever when examined by their doctors
and fever was recorded in only one cane on admission to
hospital.
50
In isolated cases, it would obviously be difficult to
differentiate between viral hepatitis and toxic hepatitis
from chemical exposure.
Diagnosis of toxic hepatitis would
arise from a high index of suspicion.
Company doctors
would find it useful periodically to do a simple analysis
of the statistics on their patients.
This would help in
the detection and prevention of occupational disease,
which would be missed unless doctors became more aware of
a possible occupational aetiology in some of the diseases
which they see (Medical' Journal of Malaysia, March 1983:
31-4).
51
CHAPTER 7
CONCLUSION
This report has attempted to make a case for the need to
remove chloroform from all preparations containing this
compound currently being sold on the market.
In so doing,
it has examined studies on the compound as well as
literature, legislation and action taken by health
authorities on the compound, worldwide.
Chloroform has been shown to be a highly potent and highly
dangerous anaesthetic.
Given the availability of
alternative and equally effective agents on the market
today, it is clear that this compound should not be in use.
It would be worthwhile to quote once more the dangers of
this compound according to Vickers ’ Drugs in Anaesthetic
Practice: 'The major disadvantage of chloroform is its effect
on the liver, as severe liver damage can follow short
exposures.
In so-called delayed chloroform poisoning the
effects of chloroform administration appear 24-48 hours
after administration.
There is centrilobular necrosis
which, in severe cases, may become massive.
This form of
liver damage is said to be more likely to occur in starved,
dehydrated and toxic patients or in those repeatedly exposed
to chloroform. 1 (Vickers, et al, 1979: 140)
52
Children are more susceptible to the adverse effects of
this compound because they are repeatedly exposed to
preparations containing this compound.
Many of the
advertisements for products containing chloroform, for
example, cough mixtures, are directly aimed at children.
Drug companies cannot be allowed to promote medicines
containing such compound.
This can lead to irrational
use of the medicines.
CAP strongly urges the Ministry of Health to immediately
recall all preparations containing this compound from the
market and ban the use of chloroform in such preparations
in the future, for the safety and health of Malaysian
consumers.
53
REFERENCES
1.
Ahmadizadeh, M, et al, ’Sex and Strain Differences
in Mouse Kidney: Bowman’s Capsule Morphology and
Susceptibility to Chloroform’, Toxicology Letters,
1984 Vol 20: 161-72.
2.
Ang Mamimili , April 1978 Vol VII No 4: 66.
3.
Berita Farmasi, ’Society News’, February 1977 Vol 4
No 2: 27.
4.
Consolidated List of Products Whose Consumption
and/or Sale Have Been Banned, Withdrawn, Severely
Restricted or Not Approved by Governments, Prepared
by the United Nations Secretariat in response to
General Assembly resolution 37/137, 30 December 1983.
5.
Department of Health and Social Security, UK, The
Medicines (Chloroform Prohibition) Order SI 1979:
382, cf WHO DIB, ’Chloroform and Carcinogenesis’
Oct-Dec 1979: 5-6.
6.
Eschenbrenner, A B, Miller, E, ’Induction of
hepatomas in mice by repeated oral administration of
chloroform, with observations on sex differences’,
Journal of the National Cancer Institute, 1945 Vol 5:
251-5, cf Public Citizen.
7.
Federal Register, 9 Feb 1973, cf Public Citizen.
8.
Goh, K T, Lee, L T, Tan, K T, and Kwok, S F, ’Toxic
Jaundice from Occupational Exposure to Chloroform’ ,
Medical Journal of Malaysia, March 1983 Vol 38
No 1: 31-4.
9.
IARC Monographs on the Evaluation of Carcinogenic
Risk of Chemicals to Man, Lyon: 1972 Vol 1: 61-5, cf
Public Citizen.
10-.
Journal of the American tMedical Association, 1973
Vol 224: 621, cf Public Citizen.
54
11.
Martindale, The Extra Pharmacopoeia, 28th edition,
1982.
12.
National Cancer Institute ’Report on the Carcino
genesis Bioassay of Chloroform’, 1976, cf WHO DIB
’Potential Carcinogenicity of Chloroform’, October
1976: 13.
13.
National Institute for Occupational Safety and Health,
Rockville, USA, cf The Medical Journal of Australia,
4 Feb 1984: 184.
14.
Parish, Peter, Medicines: A Guide for Everybody,
Hammonds Worth, Middlesex: Penguin 1976: 314.
15.
Pohl, L R, et al, ’Strain and Sex Differences in
Chloroform - Induced Nephrotoxicity, Drug Metabolism
and Disposition’, The American Society of Pharmacology
and Experimental Therapeutics 1984 Vol 12 No 3: 304-8.
16.
Public Citizen, ’Dr Sidney Wolfe’s letter to the
Commissioner of FDA, Dr Alexander M Schmidt’, Health
Research Group, 30 December 1975.
17.
UICC Monograph Series 1967 Vol 1: 135, cf Public
Ci ti zen.
18.
Vickers, M D, Wood-Smith, F G, Stewart, H C,
Drugs in Anaesthetic Practice 5th ed, 1979: 140.
19.
WHO Drug Information Bulletin:
a)
’Potential Carcinogenicity of Chloroform’,
October 1976: 13.
b)
’Regulatory Decisions Taken in 1976’, JanuaryMarch 1977: 19.
c)
’Other Recent Regulatory Decisions’, JanuaryMarch 1979: 19.
d)
’Other Recent Regulatory Decisions’, April-June
1984: 25.
55
APPENDIX 1
DOSAGE INSTRUCTIONS FOR WOODS' GREAT PEPPERMINT
CURE
APPENDIX 2
DOSAGE INSTRUCTIONS FOR BOON'S COUGH REMEDY
APPENDIX 3
DOSAGE INSTRUCTIONS FOR BREACOL COUGH SYRUP
APPENDIX 4
PACKAGE INSERT FOR KWAN LOONG MEDICATED OIL
APPENDIX 5
PACKAGE INSERT FOR TIGER OIL
A RJ -ft °
«« »
» A 41 > iM. ’ MiR
A°
, n* ,
♦ %&££. ’ #i&’S
’ &£±&$ = jiF^WSA^ ■>
TIGER OIL
(FOR EXTERNAL USE ONLY)
. TIGER OIL is manufactured by the most up-to-date pharmaceutical processes. Its produc
tion is carefully controlled at all stages by skilled pharmacists and chemists to give a product
of the highest quality.
Only ingredients of proven efficacy, highest purity and quality are used. This preparation
is a time-tested and effective household remedy for the Symptomatic relief of:
HEADACHE, STOMACHACHE. COLDS. COUGHS. GIDDINESS. OVERWORK. MENTAL
r>.ne^-r.^I,RER^ESS- ,N?.ECT BITES. TRAVELLING SICKNESS. RHEUMATISM.
DIRECTIONS: Where applicable, rub gently on affected parts with a few drops of TIGER OIL.
Otherwise use as an inhalant.
Made under licence from
HAW PAR BROTHERS INTERNATIONAL LTD.
MINYAK HARIMAU
(UNTOK DI-SAPUKAN DI-LUAR SAHAJA)
MINYAK HARIMAU, di-buat menurut peroses pembuat obat yang paling terbaharu sekali.
Pengeluaran-nya di-awasi dengan teliti dari segala segi oleh ahli2 kimia dan farmasi yang bijak
untok menghasilkan ketinggian mutu-nya.
Hanya ramuan2 yang berseh dan tinggi mutu-nya dan telah lama tahan uji sahaja yang
telah di-gunakan.
Ada-lah persediaan dan cbat yang sangat mujarab di-simpan di-rumah bag! melegakan
dengan segera sakitZ:
PENING KEPALA, SAKIT PERUT, SALSEMA. BATOK, PITAM, TERLALU BANYAK
BEKERJA, LETEH OTAK, DI-GICIT SERANGGA, MABOK DI-PERJALANAN. BISA2
TULANG.
. .
.
PERATORAN-NYA: Chara menggunakan-nya sapu di-tempat yang sakit dengan beberapa
titik MINYAK HARIMAU. Jika tidak. boleh juga di-buat sa-bagai obat chium.
Di-perbuat daripada
HAW PAR BORTHERS INTERNATIONAL LTD.
APPENDIX 6
PACKAGE INSERT FOR GOLD FISH MEDICATED OIL
TRADE
fi. ft ft
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A
* £f. A A &
&
£
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i£ A
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U 46 m M ij it
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IX
GOLDFISH MEDICATED OIL
LAQINO
MAOHANDA
NO
LANGU
NA 'OOLDraB-
HWONG LAG ANO ’ OOCDftSH MEDICATED O<'
Drugs and the Third World:
Chloroform
Sale and Hazards
— a Malaysian Study
Chloroform is a highly potent and dangerous anaesthetic which can
cause damage to the liver as well as the kidneys. It is a proven car
cinogen as well.
Many countries have banned the use of chloroform. However it
continues to be found in many products marketed in Malaysia.
These include medicinal preparations such as cough mixtures.
This study highlights the dangers of continued exposure to chloro
form, and calls for a tightening of local health regulations regarding
the compound.
The Consumers* Association of Penang (CAP) is a non-profit making organisa
tion which fights for the rights and interests of Malaysian consumers through
research, educational and representational activities.
The issues it takes up include the fulfilment of basic needs (food, nutrition,
health, housing, transport, etc.), food and product safety, environmental po u
tion and problems, the rational use of resources, specific problems o women,
and business malpractices.
This is part of a series of CAP Reports aimed at providing the Pu^ nJ^Mhis
results of some of the important areas of CAP’s activities, t is °P
towards
series will generate public interest and awareness, and help to contr
a better life for Malaysians.
of Penang 1986
Copyright ©Consumers’ Assochuion 9950 - 24-7
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