{"id":493,"date":"2014-12-10T11:00:18","date_gmt":"2014-12-10T11:00:18","guid":{"rendered":"http:\/\/stg-blogs.bmj.com\/bmjebmspotlight\/?p=493"},"modified":"2017-08-21T12:08:27","modified_gmt":"2017-08-21T12:08:27","slug":"primary-care-corner-with-geoffrey-modest-md-new-drug-labeling-for-pregnancy-and-lactation-fda","status":"publish","type":"post","link":"https:\/\/stg-blogs.bmj.com\/bmjebmspotlight\/2014\/12\/10\/primary-care-corner-with-geoffrey-modest-md-new-drug-labeling-for-pregnancy-and-lactation-fda\/","title":{"rendered":"Primary Care Corner with Geoffrey Modest MD: New drug labeling for pregnancy and lactation FDA"},"content":{"rendered":"<p><strong>By: Dr. Geoffrey Modest<\/strong><\/p>\n<p>The FDA just came out\u00a0with\u00a0changes in labeling information regarding pregnancy and lactation on prescription drugs and biological products, replacing the old system of letter categories (A, B, C, D and X)\u200b. These changes will go into effect June 30, 2015 (see <a href=\"http:\/\/www.fda.gov\/NewsEvents\/Newsroom\/PressAnnouncements\/ucm425317.htm\">FDA release<\/a>).<\/p>\n<p>In brief:<\/p>\n<p><a href=\"https:\/\/stg-blogs.bmj.com\/bmjebmspotlight\/files\/2014\/12\/Untitled1.jpg\"><img loading=\"lazy\" decoding=\"async\" class=\"alignright wp-image-492\" src=\"https:\/\/stg-blogs.bmj.com\/bmjebmspotlight\/files\/2014\/12\/Untitled1-300x152.jpg\" alt=\"Untitled\" width=\"278\" height=\"141\" \/><\/a>&#8211;The &#8220;pregnancy&#8221; subsection will provide information on the\u00a0use of the drug in pregnant women (eg, dosing and potential risks to the fetus), and\u00a0whether there is a registry collecting data on how pregnant women are affected by the drug.<\/p>\n<p>&#8211;The &#8220;lactation&#8221; subsection will comment on the amount of drug in breast milk and potential effects on the breastfed child<\/p>\n<p>&#8211;The &#8220;females and males of \u00a0reproductive potential&#8221; subsection \u00a0will include comments on the drug&#8217;s effect on\u00a0pregnancy testing, contraception, and infertility<\/p>\n<p>&#8211;Both the &#8220;pregnancy&#8221; and &#8220;lactation&#8221; subsections will include 3 subheadings: &#8220;risk summary&#8221;, &#8220;clinical considerations&#8221; and &#8220;data&#8221;, with information on human and animal data and specific adverse reactions of concern for pregnant of lactating females<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>New drug labeling for pregnancy and lactation FDA [&#8230;]<\/p>\n<p><a class=\"btn btn-secondary understrap-read-more-link\" href=\"https:\/\/stg-blogs.bmj.com\/bmjebmspotlight\/2014\/12\/10\/primary-care-corner-with-geoffrey-modest-md-new-drug-labeling-for-pregnancy-and-lactation-fda\/\">Read More&#8230;<\/a><\/p>\n","protected":false},"author":148,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_jetpack_memberships_contains_paid_content":false,"footnotes":""},"categories":[14283],"tags":[],"class_list":["post-493","post","type-post","status-publish","format-standard","hentry","category-archive"],"jetpack_featured_media_url":"","jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/stg-blogs.bmj.com\/bmjebmspotlight\/wp-json\/wp\/v2\/posts\/493","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/stg-blogs.bmj.com\/bmjebmspotlight\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/stg-blogs.bmj.com\/bmjebmspotlight\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/stg-blogs.bmj.com\/bmjebmspotlight\/wp-json\/wp\/v2\/users\/148"}],"replies":[{"embeddable":true,"href":"https:\/\/stg-blogs.bmj.com\/bmjebmspotlight\/wp-json\/wp\/v2\/comments?post=493"}],"version-history":[{"count":0,"href":"https:\/\/stg-blogs.bmj.com\/bmjebmspotlight\/wp-json\/wp\/v2\/posts\/493\/revisions"}],"wp:attachment":[{"href":"https:\/\/stg-blogs.bmj.com\/bmjebmspotlight\/wp-json\/wp\/v2\/media?parent=493"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/stg-blogs.bmj.com\/bmjebmspotlight\/wp-json\/wp\/v2\/categories?post=493"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/stg-blogs.bmj.com\/bmjebmspotlight\/wp-json\/wp\/v2\/tags?post=493"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}