Thalidomide is back, and the public is concerned. The drug taken by pregnant women in the 1950s that left their babies with congenital amputations was approved by the Food and Drug Administration for the first time in the United States in 1998.

Thalidomide Approved
Thalidomide, under the brand name thalomid, was approved for the treatment of erythema nodosum leprosuma, a complication of leprosy, which leaves the affected person with a disfiguring skin disorder. Two years prior, the FDA approved thalidomide, in conjunction with the drug dexamethasone, for the treatment of multiple myeloma, a bone marrow cancer. Physicians may also prescribe thalomid for patients with other conditions.

Thalidomide sales have skyrocketed as physicians prescribe the drug for a multitude of conditions. Sales were nearly half a billion dollars for the first nine months of 2008. Another thalidomide derivative, Revlimid, saw sales of nearly one billion dollars for the first nine months of 2008.

Congenital Amputation Rampant
Physicians in Europe first prescribed thalidomide in the late 1950s to treat anxiety, insomnia and, for pregnant women, morning sickness. It was withdrawn from the market in the early 1960s when physicians learned that mothers were giving birth to congenital amputees and babies with other severe birth defects. About 10,000 children around the world were born with congenital amputations and other malformations because their mothers had taken the drug during early pregnancy. 

STEPS Program
This time around, the FDA is taking no chances. To avoid women having babies with congenital amputations, the FDA has established the System for Thalidomide Education and Prescribing Safety (STEPS) oversight program. All physicians writing a prescription and pharmacists filling those prescriptions for thalomid must register in the STEPS program.

Physicians must provide counseling on the risks and benefits of thalidomide, and patients must complete an informed consent form and survey enrollment form. Female patients must agree in writing to use two methods of birth control and undergo frequent pregnancy testing, and men must guarantee to use a condom because thalidomide may be present in semen.

The approval of thalidomide has created a great amount of concern among the now adult congenital amputatee children whose mothers took thalidomide back in the 1950s.


“The FDA claims it has implemented very strict regulations for marketing and prescribing thalidomide to avoid exposure to pregnant women,” says health writer Michele Moss. “This all looks great on paper but is enveloped with one major loophole – trust in human nature. I do not believe the FDA and its strict regulations will be one hundred percent successful in the prevention of more ‘Thalidomide Babies.’  Where do we draw the line? Do we wait for history to repeat itself?”