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 Monday, 20 January, 2003, 15:05 GMT
Authorities assess thalidomide return
Thalidomide was banned in 1962
The controversial drug thalidomide could soon be available to patients across Europe - 40 years after it was banned.

European Union authorities are considering whether the drug should be given to patients with a rare form of cancer and those with leprosy.

At present, thalidomide is unlicensed in Europe and can only be prescribed under strict controls.

We are looking at this very carefully

EMEA spokesman
The drug was marketed in the 1950s and 1960s as a cure for morning sickness. It was banned after mothers who took it gave birth to deformed children.

However, recent studies have suggested thalidomide could be a weapon in the fight against cancer and could help people with Aids and other serious diseases.

Decision due

The European Agency for the Evaluation of Medicinal Products (EMEA) is now considering whether the drug should be re-licensed for use across the EU.

Even if the drug is approved for use, it will only be used on specific patients. These include patients diagnosed with multiple myeloma, a cancer of the bone marrow, which affects about 20,000 patients in Europe each year.

It could also be prescribed to patients with Type II leprosy who suffer a reaction to conventional treatments.

A spokesman for the EMEA said no decision had yet been made.

"We are looking at this very carefully. We are also looking at a possible risk management programme if the drug is made available," he said.

EMEA officials met representatives of thalidomide victims on Monday as part of their consultation process.

The day-long meeting focused on what safeguards would be needed if the drug is re-licensed.

Among those attending the meeting in London was Freddie Astbury, chairman of Thalidomide UK, a group representing victims of the drug.

In the past, the group has been critical of attempts to license thalidomide and warned it was a "ticking time bomb".

However, speaking ahead of the meeting Mr Astbury said he and his colleagues were determined to keep an open mind about the EMEA talks.

Strict controls

Earlier, Dr Claus Newman, a specialist in birth defects based at Queen Mary's Hospital in Roehampton, called for tight controls if thalidomide is made available again.

He suggested that an independent ombudsman should be appointed to oversee its use and to guard against human error.

"Everything is subject to human error and on that basis, if there is wider use of the drug, there will be some accidents," he said.

"Thalidomide is a unique drug with powerful effects potentially for harm and good. Its wider licensing will require extraordinary measures."

See also:

30 Oct 02 | Health
14 Feb 00 | Health
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