The Titanic has become a metaphor for the disastrous consequences of an 
unqualified belief in the safety and invincibility of new technology. Similarly, 
the thalidomide tragedy stands for all of the "monsters" that can be 
inadvertently or negligently created by modern medicine. Thalidomide, once 
banned, has returned to the center of controversy with the Food and Drug 
Administration's (FDA's) announcement that thalidomide will be placed on the 
market for the treatment of erythema nodosum leprosum, a severe dermatological 
complication of Hansen's disease. Although this indication is very restricted, 
thalidomide will be available for off-label uses once it is on the market. New 
laws regarding abortion and a new technology, ultrasound, make reasonable the 
approval of thalidomide for patients who suffer from serious conditions it can 
alleviate. In addition, the FDA and the manufacturer have proposed the most 
stringent postmarketing monitoring ever used for a prescription drug, including 
counseling, contraception, and ultrasonography in the event of pregnancy. The 
Titanic/thalidomide lesson for the FDA and public health is that rules and 
guidelines alone are not sufficient to guarantee safety. Continuous vigilance 
will be required to ensure that all reasonable postmarketing monitoring steps 
are actually taken to avoid predictable and preventable teratogenic disasters.