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Thalidomide Baby

Thalidomide Baby

The First Appearance Of Thalidomide

Thalidomide first appeared in Germany on 1st October 1957. It was marketed as a sedative with apparently remarkably few side effects. The Drug Company who developed it believed it was so safe it was suitable for prescribing to pregnant women to help combat morning sickness.

It was quickly being prescribed to thousands of women and spread to most corners of the globe. Nobody had any idea of what was to follow. Drug testing procedures were far more relaxed at this time, and although tests had taken place on thalidomide, they didn't reveal any of its tetragenic (roughly meaning causing malformations) properties. In most countries, drug companies were not required to submit testing results to the appropriate government agencies.

The tests on thalidomide were conducted on rodents which metabolise the drug in a different way to humans. Later tests on rabbits and monkeys produced the same horrific side effects as in humans.

Some thalidomide babiesTowards the end of the fifties, children began to be born with shocking disabilities. It was not immediately obvious what the cause of this was. Probably the most renowned is Pharcomelia, the name given to the flipper-like limbs which appeared on the children of women who took thalidomide. Babies effected by this tragedy were given the name 'Thalidomide Babies'.

Pictured right are some of babies born with the flipper-like limbs. Remarkably, many of the children involved have gone on to lead successful and fulfilling lives.

Who took thalidomide?

Thalidomide was promoted as a ‘wonder drug’ to treat a range of conditions including headaches, insomnia and depression. It was popular because it was atoxic and so it was impossible to overdose on it. However, long term use led to irreversible peripheral neuritis in a large number of patients. It was then remarketed as a short-term treatment for pregnant women, typically in the first three months of their pregnancy, to combat morning sickness or insomnia although it was also prescribed for bronchitis and influenza amongst other things. It also appeared in cough medicines for children and so often it stayed in medicine cabinets long after its withdrawal from the market.

When was Thalidomide withdrawn?

Recent evidence shows that Chemie Grünenthal ignored warnings about the connection between thalidomide and babies being born with limb and other impairments. In 1961, Australian doctor William McBride, published a letter in The Lancet making this connection public knowledge. Following this and reports of what amounted to an epidemic of births of malformed babies and side effects of peripheral neuritis in adults in Germany,  Chemie Grünenthal reluctantly withdrew the drug in November 1961 and Distillers followed suit in the December of that year.

However, a UK Government warning was not issued until May 1962 but, even then, the drug was also present in a number of other medications whose labelling did not use the word ‘Thalidomide’. Consequently at least 20 children were born during and after September 1962 showing typical thalidomide impairments more than nine months after Distaval was withdrawn.

The late Professor Smithells, of the Department of Child Health and Paediatrics at Leeds University, has said, “There was a dramatic disappearance of this type of deformity within a year of the drug’s withdrawal.”

Why were some countries more affected by thalidomide than others?

In the United States, the thalidomide experience was very different from that in Europe. Fortunately Dr. Frances Kelsey of the US Food and Drug Administration was more alert and would not accept that the drug had been adequately tested for manufacture and distribution. As a result only about 20 thalidomide impaired babies were born in America and these were a result of the limited clinical trials that were carried out.

In contrast, in Germany the drug was contained in a preparation called Contergan, which was sold over the counter in pharmacies. The use of Contergan resulted in the births of at least 6,000 impaired children, of whom only 2,000 have survived. These figures are, of course, based on known deaths and survivors and are likely to be much higher.

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