The FDA has given approval to a prescription medication used to treat morning sickness that was pulled off the market 30 years ago after hundreds of lawsuits claimed it caused birth defects.
The pill, which was once called Bendectin—used by roughly 33 million nauseated pregnant women before it was yanked off shelves in 1983—will reenter pharmacies this June as Diclegis. The FDA had never deemed the drug to be unsafe, but Merrell Dow, the pharmaceutical company behind the pill, stopped making it once litigation costs outweighed profits.
Between 1978 and 1983, over 300 lawsuits were filed against the company claiming damages for babies with deformities born to mothers who took the drug. But there was never any scientific evidence proving a link between the drug and the wide range of birth defects attributed to it, like limb and other musculoskeletal deformities; facial and brain damage; defects of the respiratory, gastrointestinal, cardiovascular and genital-urinary systems; blood disorders and cancer. Thirty years ago, The New York Times had reported on the controversy, saying:
Doctors know of no teratogen - an agent that causes birth defects - that produces anything resembling this variety of problems. Nearly all teratogens act at specific times during fetal development and affect the organs then forming…The case against Bendectin is unclear. The Food and Drug Administration admitted as much in 1980, after an intensive two-day review of available data. The review panel said no association between Bendectin and birth defects had been demonstrated. It added, however, that because there was no way to prove the absolute safety of any drug in all women under every circumstance, there must remain a ''residual uncertainty'' about how this drug affects an unborn child.
After the Thalidomide scare in the 1960s, it makes sense that there would be extra caution taken when using medication, but even in 2013, advice for pregnant women is often contradictory and based more on theory than proven science. But the sale of Diclegis is great news for chronically nauseous pregnant women who have had no real relief for their symptoms other than to eat some crackers and ginger.
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