Thalidomide, the drug that blighted a generation of children half a century ago, is back on the market in Europe as a powerful cancer treatment.

The European drug agency yesterday gave clearance for thalidomide to be sold on prescription for treating newly diagnosed multiple myeloma.

It has been available, in a limited way, for some years since its powerful effects on cancer and leprosy were identified.

But campaigners, including those damaged by the drug when they were still in the womb, are anxious that its new-found popularity does not lead to more babies being harmed.

Freddie Astbury, the president and founder of the campaign group Thalidomide UK, said that since the drug resurfaced, hundreds of damaged babies had been born in Brazil, where it has been used since 1985 to treat leprosy. There had been no such cases in the US or Europe, he said, but admitted that he was worried by the increased availability of the drug.

“The trouble is that some hospitals in Europe have chosen to get the drug from Brazil, where it is cheaper,” he said.

Thalidomide UK and other patient groups had been working with the European Medicines Agency (EMEA) for more than five years on a plan to control access to the drug once it was licensed, Mr Astbury said.

“We’re never fully going to know how the plan will work until the drug is used on a large number of patients,” he said. “I’d never say there will never be another thalidomide child in Europe, but I think they are the best guidelines we could have achieved.”

The approval given by the EMEA means that the US company Celgene will be the only licence-holder in Europe, and will be responsible for ensuring that the guidelines are observed. No other manufacturers and distributors of thalidomide can now supply the drug across the EU.

Thalidomide was originally marketed in the late 1950s as a treatment for morning sickness in pregnant women. It was only when babies began being born disabled that the dangers became apparent. The catastrophe was a landmark in the development of safer systems for approving drugs.

A drug commonly used in cancer therapy has been linked to brain changes that may be long-lasting. So-called chemo-brain is the phenomenon of short-term memory loss and difficulty concentrating experienced by many cancer patients. It is usually put down to a combination of tiredness, anxiety and depression. But a new study in the US has shown that one cancer drug, 5-fluorouracil, (5-FU) can cause damage to brain cells that may help explain “chemo-brain”, the Journal of Biology reports.

Blighted lives

— Thalidomide went on sale as a treatment for morning sickness in 1958 in more than 40 countries

— In Britain the most commonly prescribed drug containing thalidomide was Distaval, manufactured by the Distillers Company, now owned by Diageo

— Foetuses are vulnerable to the drug’s effects between 27 and 40 days after conception

— The drug caused deformities in up to 12,000 infants. Of these, 5,000 survived beyond childhood

— The drug was taken off the market in Britain in December 1961, though a government warning was not issued until May 1962

— The first compensation was paid in 1968. In 1973 – after a campaign by David Mason, a victim’s father, and The Sunday Times – the Thalidomide Trust was set up, providing a £20 million fund

— The average compensation paid to a victim is £13,000 per year

Sources: britannica.com; thalidomidesociety.co.uk; thalidomideuk.com; thalidomide.org.uk

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