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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.
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 04 Sep 00 | Health 14 Feb 00 | Health Internet links: The BBC is not responsible for the content of external internet sites Top Health stories now: Links to more Health stories are at the foot of the page. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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