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Fifty years of independent expert advice on prescription medicines

How it led to the formation of the Australian Drug Evaluation Committee

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12 February 2014

The thalidomide tragedy

Old-fashioned television1956 Melbourne hosted the Olympic Games, television arrived in Australia, and the first child with disability caused by the medicine thalidomide was born to an employee of the German pharmaceutical company, who had taken samples home to his wife.

Thalidomide was marketed as a wonder drug - an effective tranquiliser and pain killer useful for insomnia, coughs and headaches - and it helped pregnant women with morning sickness!

It was considered to be safe: in contrast to older tranquilisers, an overdose did not result in death, but simply an extra long sleep.

However, no studies had been conducted to investigate the safety of thalidomide for the unborn child.

In 1961 a German paediatrician, Dr HR Wiedemann, described an 'epidemic' of babies being born with limb malformations, but the cause of this epidemic was unknown.

Linking birth defects to thalidomide

Woman holding a childAt the end of 1961, the Australian Dr William McBride and the German Dr Widukind Lenz separately worked out the likely cause and effect relationship between thalidomide use in early pregnancy and birth defects.

'In recent months I have observed that the incidence of multiple severe abnormalities in babies delivered of women who were given the drug thalidomide ('Distival') during pregnancy, as an anti-emetic or as a sedative, to be almost 20%.'

WG McBride, The Lancet, Dec 1961

Thalidomide was withdrawn in Australia, Germany and the UK by the end of 1961. Eight months after the withdrawal of thalidomide, babies stopped being born with the characteristic limb defects.

About 40% of babies damaged by the effects of thalidomide died in their first year. But there are adults alive today who are living with disabilities caused by thalidomide.

Photo of Professor Edgar Thomson

Professor Edgar Thomson
CMG, OSt J, MB, ChB, FRACP, FRIPH, MCPA, FHA, FRACMA, FRCPA, first chair of ADEC, 1963–1966

Professor Thomson was the founding president of the College of Pathologists of Australia, chair of the Australian Red Cross Society's national transfusion committee and chair of the National Health and Medical Research Council's antibiotics advisory committee.

Australian response to thalidomide tragedy

The thalidomide experience brought home to Australians the message that medicines have risks as well as benefits.

'Never again' was the wish of the Australian community, but what was the appropriate response?

It was decided that an independent committee should be set up to monitor the safety of new medicines as well as medicines that were already available. To achieve this, the Australian Government established the Australian Drug Evaluation Committee (ADEC) in June 1963.

'Government control does not absolve drug manufacturers from the responsibility of conducting adequate laboratory and clinical tests to ensure, as far as this is possible, the safety of drugs before they are offered to the public.'

AJ Forbes, Minister for Health, 1967
(preface to the Report of the Australian Drug Evaluation Committee June 1963–December 1966)

Thalidomide - now used to treat cancer and leprosy

Since 2008 thalidomide has been authorised to be used to treat a particular type of cancer (multiple myeloma) and it is now also authorised for the treatment of a complication of leprosy (erythema nodosum leprosum).

Thalidomide is supplied under strictly controlled conditions, and with a clear warning stating that even a single dose can cause severe birth defects.thalidomide molecule

Consumer Medicine Information warning for thalidomide

Severe life-threatening birth defects:
Thalidomide has caused severe birth defects when taken during pregnancy. Thalidomide should never be used by women who are pregnant or who could become pregnant whilst taking the drug or could become pregnant within 4 weeks after stopping the drug. Even a single dose can cause severe birth defects.

Product Information warning for thalidomide

Teratogenic effects:
Thalidomide has caused severe birth defects when taken during pregnancy. Thalidomide should never be used by women who are pregnant or who could become pregnant whilst taking the drug or could become pregnant within 4 weeks after stopping the drug. Even a single dose can cause birth defects.

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