New York - Strict monitoring, including giving female patients monthly pregnancy tests will accompany the introduction in the United States of the controversial drug Thalidomide, which left thousands of children without limbs when it was first used in Britain during the 1960s.
The US Food and Drug Administration refused to approve Thalidomide 37 years ago when it was being marketed as a sedative, for fear that it might affect the nervous system. As a result just 17 Thalidomide babies were born in the US, compared to 10,000 worldwide. But the FDA now accepts restricted use could be beneficial to thousands of patients suffering from AIDS and other auto-immune diseases. The drug will also be prescribed for treatment in brain cancer and to many of the 7,000 victims of leprosy in the US. Although it is accepted that the drug would still cause terrible side-effects in pregnant women, Celgene, its manufacturer, said its distribution would be severely monitored.