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Side Effects of Drugs Identified After FDA Approvals

According to a recent study, involving 222 medications FDA approved between 2000 and 2010, 32% of these drugs were found to have safety risks after being on the market, (Nicholas S. Downing, Nilay D. Shah, Jenerius A. Aminawung, Alison M. Pease, Jean-David Zeitoun, Harlan M. Krumholz, Joseph S. Ross, "Theraputics Approved by the US Food and Drug Administration Between 2001 and 2010," JAMA 317, no. 18 (2017): 1854-1863, doi:10.1001/jama.2017.5150). The risks were higher for psychiatric medications, medications that received accelerated approval and near-regulatory deadline approval. The median follow-up time for the study was 11.7 years. After these medications were approved, the median time for the FDA to either withdraw the drug, issue a boxed warning or a safety communication was 4.2 years. This poses a greater concern for individuals with autism or other communication impairments, who may not be able to communicate side effects, posing an increased risk of morbidity and mortality.