TY - CHAP M1 - Book, Section TI - Postmarketing Drug Safety A1 - Stein, C. Michael A1 - Ray, Wayne A. A2 - Brunton, Laurence L. A2 - Knollmann, Björn C. PY - 2023 T2 - Goodman & Gilman's: The Pharmacological Basis of Therapeutics, 14th Edition AB - Initiatives to improve the safety of drugs after they are marketed arose from the recognition that rare potentially serious adverse drugs reactions (ADRs) are usually identified only after a drug is in clinical use. One has only to recall the example of phocomelia in newborns from exposure to thalidomide, a drug not approved for use in the U.S. at the time but used widely elsewhere from 1957 to 1961 to treat morning sickness in pregnant women and that caused congenital malformations in over 10,000 children (Vargesson, 2015). As a result of this tragedy and other ADRs, many countries have developed postmarketing surveillance systems to identify ADRs and to determine their prevalence and impact. SN - PB - McGraw-Hill Education CY - New York, NY Y2 - 2024/03/29 UR - hemonc.mhmedical.com/content.aspx?aid=1193227286 ER -