What studies are conducted to determine whether an agent is a teratogen?
The following studies may be conducted to determine whether or not an agent is a teratogen: • Animal studies Animal studies are the primary study method to determine whether a medication, or other environmental exposure, is safe during human pregnancy. In the past, there have been medications on the market that humans used which caused birth defects, such as thalidomide in the 1960’s. Thalidomide was removed from the market after several babies were born with missing and malformed limbs to mothers who took thalidomide early in pregnancy. Thalidomide has recently been approved by the FDA for the treatment of certain diseases, but it is only available by a physician’s prescription. • Observations from human exposure Observations from human exposure (prior to federal regulations for drug testing) are another important way to determine whether a medication is a teratogen. The official criteria for determining whether an agent is teratogenic in humans was determined by Koch in 1971. They ar
