The Scottish Medicines Consortium (SMC) has relaxed a 48-year old ban on thalidomide (Thalomid) following a recommendation by the European Medicines Agency, a pharmaceutical regulatory resource.  This decision approves the use of thalidomide for first-line treatment of multiple myeloma in combination with melphalan and prednisone, and is restricted to patients over 65 or who cannot receive high-dose chemotherapy.

Patients in a recent study experienced an overall survival advantage of 18.4 months when treated with thalidomide with melphalan and prednisone.  The SMC, which measures drugs on their cost-effectiveness, estimates that relaxing restrictions on thalidomide will benefit some 179 patients for £3 million per year.

Thalidomide, a sedative-hypnotic drug, was previously approved for off-label use in the UK only in exceptional cases.  This recent policy revision allows doctors in Scotland to prescribe thalidomide without arguing each individual case in front of a health board, and thereby expedites the process of getting the drug to the patient.

Thalidomide was originally prescribed in the 1950s for morning sickness and anxiety in pregnant women, but led to approximately 10,000 children born with birth defects in Europe, Japan, and Canada.  Once the connection was made in 1961, the European Medicines Agency banned the sale of thalidomide in the UK.  To prevent the tragedies of fifty years ago, thalidomide's UK producer, Pharmion, has partnered with Thalidomide UK in developing a Pregnancy Prevention Programme (PPP) to prevent further birth defects due to thalidomide consumption during pregnancy.  Thalidomide UK supports individuals who were born with deformities related to thalidomide consumption by their mothers.

The drug has been approved in the US since 2006, and is also prescribed for the treatment of some forms of leprosy.  For more information refer to Channel 4 News and The Herald.