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8 Inspiring Moments in Women’s Health History

1962: Birth Defect Warnings for Drugs Like Thalidomide

New federal regulations in the United States took effect in 1962 to ensure that drugs would not cause birth defects during pregnancy or harm breastfeeding infants. This change came after the thalidomide birth defect scare of the late 1950s. Thalidomide was marketed as a sedative and sold off-label to treat morning sickness, starting in Germany and then in countries around the world. Thalidomide was not approved in the United States, but many U.S. physicians received the drug during the clinical testing period and provided it to their patients. Doctors began to notice an odd pattern of severe birth defects including malformed or missing arms and legs. Eventually they determined that exposure to thalidomide during pregnancy was the cause of these birth defects. The thalidomide tragedy resulted in changes in drug development policy, including requirements to test drugs in animals to identify potential harms to pregnant women and fetuses. In addition, drug labels had to clearly indicate any possible risk to mother or unborn child during pregnancy. Researchers later determined that thalidomide was useful as a treatment for multiple myeloma and leprosy, and it is now approved in the United States for those uses, but it carries a label warning that it must not be taken during pregnancy, nor by women who could become pregnant.






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Date: 19.12.2018, 03:41 / Views: 95191