{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,15]],"date-time":"2026-04-15T01:58:01Z","timestamp":1776218281733,"version":"3.50.1"},"reference-count":34,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2005,11,18]],"date-time":"2005-11-18T00:00:00Z","timestamp":1132272000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Pharmacoepidemiology and Drug"],"published-print":{"date-parts":[[2006,6]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Purpose<\/jats:title><jats:p>Black box warnings (BBWs) are the Food and Drug Administration's (FDA) strongest labeling requirements for high\u2010risk medicines. It is unknown how frequently physicians prescribe BBW drugs and whether they do so in compliance with the warnings. The purpose of the present study was to assess the frequency of use of BBW medications in ambulatory care and prescribing compliance with BBW recommendations.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>This retrospective study used automated claims data of 929\u2009958 enrollees in 10 geographically diverse health plans in the United States to estimate frequency of use in ambulatory care of 216 BBW drugs\/drug groups between 1\/1\/99 and 31\/6\/01. We assessed dispensing compliance with the BBW requirements for selected drugs.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>During a 30\u2010month period, more than 40% of enrollees received at least one medication that carried a BBW that could potentially apply to them. We found few instances of prescribing during pregnancy of BBW drugs absolutely contra\u2010indicated in pregnancy. There was almost no co\u2010prescribing of contra\u2010indicated drugs with the two QT\u2010interval\u2010prolonging BBW drugs evaluated. Most non\u2010compliance occurred with recommendations for baseline laboratory monitoring (49.6% of all therapy initiations that should have been accompanied by baseline laboratory monitoring were not).<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Many individuals receive drugs considered to carry the potential for serious risk. For some of these drugs, use is largely consistent with their BBW, while for others it is not. Since it will not be possible to avoid certain drug\u2010 associated risks, it will be important to develop effective methods to use BBWs and other methods to minimize risks. Copyright \u00a9 2005 John Wiley &amp; Sons, Ltd.<\/jats:p><\/jats:sec>","DOI":"10.1002\/pds.1193","type":"journal-article","created":{"date-parts":[[2005,11,18]],"date-time":"2005-11-18T10:16:25Z","timestamp":1132308985000},"page":"369-386","source":"Crossref","is-referenced-by-count":73,"title":["FDA drug prescribing warnings: is the black box half empty or half full?"],"prefix":"10.1002","volume":"15","author":[{"given":"Anita K.","family":"Wagner","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"K. 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