May 26, 2016
(Pro Publica) – Zofran is far from unique — almost every drug prescribed during pregnancy in the U.S. is “off label,” meaning it hasn’t gone through the clinical trials required by the Food and Drug Administration before approving a drug for a specific use in a specific population. Only eight medications are currently approved by the FDA for prenatal use; from 1995 to 2011, the agency OK’d only one pregnancy-related drug. (By contrast, 29 drugs to treat cardiovascular-related conditions have won approval just since 2010.) Pregnant women have become what researchers and ethicists call“therapeutic orphans,” reliant on drugs of uncertain risk, sometimes during the earliest and most vulnerable stages of fetal development.
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