REQUEST What are the potential uses of thalidomide in the pediatric patient population? RESPONSE BACKGROUND

Thalidomide was first introduced as a sedative agent to the German pharmaceutical market in October of 1957 by Chemie Grunenthal, a West German company.1 The drug was described as the best sedative agent for pregnant and nursing mothers because of its rapid onset of effect and ap-parent safety. In the US, thalidomide was not yet approved by the Food and Drug Administration (FDA) because of its peripheral neuropathy adverse effect.1,2 In 1961, the possibility of an association between infants born with se-vere limb malformations and organ defects and thalido-mide was noted. This resulted in Chemie Grunenthal with-drawing the drug from the market due to this adverse ef-fect. It has been estimated that more than 8000 infants were born with birth defects caused by thalidomide; it is one of the most tragic events in the history of drug devel