In 1958, family physicians and obstetricians all around Europe were prescribing a new drug known as thalidomide. The German-made medication was first marketed as an anti-flu medicine. It was an excellent sleep aid and soothed anxiety too. Combined with aspirin, it solved everything from headaches to alcoholism. Thalidomide eased nausea, particularly for pregnant women suffering from morning sickness.
- Only after thousands of infants were born with a unique congenital deformity related to their limb development (called “flipper babies” at the time) was the connection made between the cure-all antiviral drug and the disability.
- By 1961, the drug was withdrawn from the market after massive public outcry.
Today, few remember the thalidomide tragedy in the US. But perhaps it’s a lesson we should remember.
Thalidomide and the FDA
The thalidomide tragedy became a key factor in future drug testing concepts. Before then, there was no special designation for medications that were safe specifically for pregnant women.
By the mid-1960s, the blockage of the sale of thalidomide in the U.S. was a symbol of the Food and Drug Administration’s vigilance. It represented the federal government’s commitment to consumer protection and healthy procreation among American families.
Why thalidomide lawsuits failed
Not all birth injuries are visible at the time of birth. That’s why here in Pennsylvania, victims of birth injury have until age 20 to recognize the possibility of a birth injury. But thalidomide defects were, for the most part, instantly and tragically apparent to parents.
Unfortunately, the issue of negligence can be challenging to prove. When thalidomide was available as a standard prescription, there was no proof it was unsafe for pregnant women. The very idea that a drug could cause harm to a fetus was novel. Therefore, it was difficult to hold prescribing physicians or drug manufacturers of the time at fault.
Thankfully, we know better now. The FDA requires that medications undergo rigorous testing before pregnant women or women who can become pregnant can take them. But that does not mean issues will not arise in the future.