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The European Medicines Agency (EMEA) is recommending Thalidomide Pharmion (thalidomide) for use to treat multiple myeloma.
The regulator’s Committee for Medicinal Products for Human Use (CHMP) said the benefits of thalidomide in combination with melphalan and prednisone outweigh its risks for patients over the age of 65, or those who cannot undergo high-dose chemotherapy.
Studies indicate the combination can increase survival rates by around 18 months in newly-diagnosed patients, compared with those on conventional chemotherapy.
Thalidomide was initially used as a morning sickness medication but was found to cause severe birth defects.
But the EMEA said it has consulted thalidomide victims and myeloma patient groups from across the EU to develop measures to minimise the risk of fetal exposure.
All women of child-bearing age taking the drug must undergo pregnancy tests before, during and after treatment, in addition to using “selected and effective” contraception.
A clear warning will also be printed on the boxes containing the medicine indicating that the drug can cause birth defects and even kill.
A statement from campaign group Thalidomide UK welcomed the move, adding: “Thalidomide UK realises that the drug that harmed so many babies 50 years ago can now help patients who suffer with multiple myeloma and other similar illnesses.”
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