RT Book, Section A1 Stein, C. Michael A1 Ray, Wayne A. A2 Brunton, Laurence L. A2 Knollmann, Björn C. SR Print(0) ID 1193227286 T1 Postmarketing Drug Safety T2 Goodman & Gilman's: The Pharmacological Basis of Therapeutics, 14th Edition YR 2023 FD 2023 PB McGraw-Hill Education PP New York, NY SN 9781264258079 LK accessmedicine.mhmedical.com/content.aspx?aid=1193227286 RD 2024/03/29 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.