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Since the 1930s and the work of Hale and Warkany on birth defects
produced by variations in dietary vitamin A, it has been recognised
that the developing fetus is particularly vulnerable to adverse
influences in the environment. . Studies of malformations at birth
remained largely in the hands of paediatricians who, for instance,
quickly established the con nection between rubella infection in
early pregnancy and the birth of severely affected infants.
However, it was through the tragic events of 1962, when dramatic
increases in the incidence of phocomelia in newborn infants in
Germany, the United Kingdom, Japan, and other countries were traced
to the use of the apparently non-toxic sedative thalidomide by
pregnant women, that toxicologists were brought face to face with
the devastating possibility of chemically-induced developmental
abnormalities. It had been shown earlier that chemotherapeutic
agents could cause damage to the developing organism, but the
absence of any known examples of drug-induced birth defects had
produced an air of complacency which was reinforced by the lack of
any specific regulatory requirements for safety evaluation in this
area. The magnitude of the thalidomide tragedy, affecting some
10000 malformed children, was sufficient to cause an immediate, and
some would say hasty, reaction by government drug regulatory
agencies throughout the world to construct a test protocol which
would detect potential teratogenic substances that might give rise
to anatomical malformations.
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