{"id":282367,"date":"2022-12-29T11:30:11","date_gmt":"2022-12-29T17:30:11","guid":{"rendered":"https:\/\/www.liveaction.org\/news\/?p=282367"},"modified":"2022-12-29T11:10:22","modified_gmt":"2022-12-29T17:10:22","slug":"fda-plan-b-label-abortion","status":"publish","type":"post","link":"https:\/\/archive.liveaction.org\/news\/fda-plan-b-label-abortion\/","title":{"rendered":"FDA changes Plan B label to remove warning that it may cause abortion"},"content":{"rendered":"<div style=\"margin-top: 0px; margin-bottom: 0px;\" class=\"sharethis-inline-share-buttons\" ><\/div><p>The Plan B One-Step emergency contraception <a href=\"https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2022\/021998Orig1s005lbl.pdf\" target=\"_blank\" rel=\"noopener\">label<\/a> has been\u00a0<a href=\"https:\/\/www.reuters.com\/business\/healthcare-pharmaceuticals\/us-fda-says-plan-b-doesnt-affect-existing-pregnancy-changes-label-2022-12-23\/\">overhauled<\/a> by the U.S. Food and Drug Administration (FDA), which has removed a warning disclosing that the emergency contraception aimed at preventing ovulation may secondarily function as an abortifacient.<\/p>\n<p>The move comes just months after the Supreme Court overturned <em>Roe v. Wade<\/em>, allowing states to pass laws protecting preborn children from abortion, though Plan B first\u00a0<a href=\"https:\/\/archive.liveaction.org\/news\/plan-b-its-not-just-a-contraceptive\/\" target=\"_blank\" rel=\"noopener\">requested<\/a>\u00a0the change nearly a decade ago. Plan B has been available over the counter since 2013, and as early as 2014, Plan B requested that the FDA alter the label to state that it does not prevent the implantation of a newly formed human being \u2014 despite evidence that it has the potential to do so.<\/p>\n<p>According to the\u00a0<a href=\"https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2022\/021998Orig1s005SumR.pdf\" target=\"_blank\" rel=\"noopener\">FDA<\/a>&#8216;s new label, the drug used in Plan B \u2014 levonorgestrel (LNG) \u2014 &#8220;does not terminate an established pregnancy and does not affect a continuing pregnancy.&#8221; The government agency stated that it &#8220;determined the current science supports a conclusion that Plan B One-Step works by inhibiting or delaying ovulation and the mid-cycle hormonal changes.&#8221; It concluded, &#8220;In summary, LNG-EC is shown to act primarily by interfering with ovulation (delay or inhibition of follicle rupture and\/or the midcycle LH and related hormonal changes) and not to act through direct effect on fertilization or on the endometrium to impede implantation.&#8221;<\/p>\n<p class=\"dcr-h26idz\">It noted, \u201cThe evidence also supports the conclusion that there is no direct effect on fertilization or implantation.\u201d<\/p>\n<p>But questions remain.<\/p>\n<p><b>URGENT:\u00a0<\/b><a href=\"https:\/\/give.liveaction.org\/future-of-abortion\/?utm_source=lan&amp;utm_medium=article&amp;utm_campaign=minibomb\"><b><i>For every dollar given, 34 more people can be reached with the truth about abortion. Will you join us in this life-saving work as a monthly donor today?<\/i><\/b><\/a><\/p>\n<p>Board-certified OB\/GYN Dr. Donna Harrison, executive director of the American Association of Pro-Life Obstetricians and Gynecologists <a href=\"https:\/\/www.nationalreview.com\/2014\/10\/yes-plan-b-can-kill-embryos-donna-harrison\/\" target=\"_blank\" rel=\"noopener\">explained<\/a>\u00a0back in 2014 how Plan B could function as an abortifacient (cause the death of an embryo). In a 2014 piece for the National Review, she said:<\/p>\n<p style=\"padding-left: 30px;\"><em>When ovulation does occur after [Plan B] has been given, most of those ovulations show luteal-phase defect (see\u00a0<a href=\"https:\/\/www.ncbi.nlm.nih.gov\/pubmed\/?term=Contraception+70+(2004)+442%E2%80%93+450\" target=\"_blank\" rel=\"noopener\" data-testid=\"standard-link\">here<\/a>,\u00a0<a href=\"https:\/\/www.ncbi.nlm.nih.gov\/pubmed\/?term=Contraception+64+(2001)+227%E2%80%93234\" target=\"_blank\" rel=\"noopener\" data-testid=\"standard-link\">here<\/a>,\u00a0<a href=\"https:\/\/www.ncbi.nlm.nih.gov\/pubmed\/?term=Contraception+69+(2004)+373%E2%80%93377\" target=\"_blank\" rel=\"noopener\" data-testid=\"standard-link\">here<\/a>,\u00a0<a href=\"https:\/\/www.ncbi.nlm.nih.gov\/pubmed\/?term=Human+Reproduction+Vol.22,+No.2+pp.+434%E2%80%93439,+2007\" target=\"_blank\" rel=\"noopener\" data-testid=\"standard-link\">here<\/a>,\u00a0<a href=\"https:\/\/www.ncbi.nlm.nih.gov\/pubmed\/?term=Contraception+81+(2010):414-20\" target=\"_blank\" rel=\"noopener\" data-testid=\"standard-link\">here<\/a>, and\u00a0<a href=\"https:\/\/www.ncbi.nlm.nih.gov\/pubmed\/?term=Contraception+70+(2004)+442%E2%80%93+450\" target=\"_blank\" rel=\"noopener\" data-testid=\"standard-link\">here<\/a>).<\/em><\/p>\n<p style=\"padding-left: 30px;\"><em>That\u2019s the term for when the ovary does not produce enough progesterone to allow the embryo to survive. If the LH surge is blunted [&#8230;] then the ovary will release the egg, which can be fertilized but not produce enough progesterone [&#8230;]. So, the embryo formed would not survive long enough to produce a positive pregnancy test. And interference with the LH surge is precisely how Plan B works.<\/em><\/p>\n<p style=\"padding-left: 30px;\"><em>If Plan B is taken five to two days before egg release is due to happen, the interference with the LH signal prevents a woman from releasing an egg, no fertilization happens, and no embryo is formed.\u00a0<\/em><em>Current studies do not demonstrate a harmful effect on the embryo if Plan B is taken after egg release.<\/em><\/p>\n<p style=\"padding-left: 30px;\"><em>Many authors focus on these two facts to make the sweeping claim that Plan B has no effect on a human embryo. What they are forgetting is Plan B\u2019s effect [during&#8230;] the two-day window in which embryos can form but positive pregnancy tests don\u2019t occur. That\u2019s the window during which the studies mentioned above suggest that Plan B has a likely embryocidal effect in stopping pregnancy.<\/em><\/p>\n<p>The luteal-phase occurs after ovulation \u2014 which is triggered by the luteinizing hormone (LH) \u2014 but before menstruation. The hormone progesterone is released at this time to thicken the uterine lining in preparation for implantation. According to the <a href=\"https:\/\/www.fertilitysa.com\/fertility-treatment\/causes-of-infertility\/luteal-phase-defect\/#:~:text=A%20luteal%20phase%20defect%20is,egg%20implantation%20and%20fetal%20development.\" target=\"_blank\" rel=\"noopener\">Fertility Center of San Antonio<\/a>, a luteal-phase defect inhibits the growth of the uterine lining, which is required for embryo implantation and fetal development. It&#8217;s responsible for repeat early miscarriages, according to <a href=\"https:\/\/www.avawomen.com\/avaworld\/luteal-phase-defect\/#:~:text=A%20luteal%20phase%20defect%20occurs,phase%20being%20a%20normal%20length.\" target=\"_blank\" rel=\"noopener\">Ava Women<\/a>. According to Dr. Harrison, when Plan B is taken and ovulation does occur, it can cause a luteal-phase defect and therefore prevent the thickening of the uterine lining that is necessary for the newly formed human being to survive.<\/p>\n<p><a href=\"https:\/\/lozierinstitute.org\/emergencycontraceptives\/\" target=\"_blank\" rel=\"noopener\">Studies<\/a> have shown that all forms of emergency contraception, including Plan B, can function as abortifacients. According to the <a href=\"https:\/\/lozierinstitute.org\/emergencycontraceptives\/\" target=\"_blank\" rel=\"noopener\">Charlotte Lozier Institute&#8217;s assessment of the studies<\/a>, &#8220;All point to Plan B&#8217;s having a predominantly post-fertilization (abortifacient) MOA [mechanisms of action] when it is given during a woman&#8217;s fertile period.&#8221;<\/p>\n<p>Interestingly, as some retailers put <a href=\"https:\/\/www.axios.com\/2022\/06\/28\/plan-b-morning-after-pill-purchase-limits\" target=\"_blank\" rel=\"noopener\">caps<\/a> on how many boxes of Plan B can be ordered at once, the FDA ensured Plan B customers that the fall of <em>Roe<\/em> will have no impact on access to the emergency contraception. &#8220;Plan\u00a0B is not in any way connected to Roe v Wade,&#8221; stated the FDA. &#8220;Plan\u00a0B will continue to be made available at all major retailers without a prescription, ID or age restriction regardless of any rulings on abortion restrictions.<\/p>\n<p>&#8220;Foundation Consumer Healthcare [owner of Plan B] will continue to advocate that no legal barriers should limit a woman\u2019s access to Plan\u00a0B emergency contraception.&#8221;<\/p>\n<p><a href=\"https:\/\/pledge.liveaction.org\/?utm_source=lan&amp;utm_medium=email&amp;utm_campaign=prolife_pledge\" target=\"_blank\" rel=\"noopener\"><img decoding=\"async\" loading=\"lazy\" class=\"size-large wp-image-277267 aligncenter\" src=\"https:\/\/archive.liveaction.org\/news\/wp-content\/uploads\/2022\/10\/pledge-live-action-ad-970x250-700x180.jpg\" alt=\"\" width=\"700\" height=\"180\" \/><\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>The Plan B One-Step emergency contraception label has been\u00a0overhauled by the U.S. Food and Drug Administration (FDA), which has removed a warning disclosing that the emergency contraception aimed at preventing ovulation may secondarily function as an abortifacient. The move comes just months after the Supreme Court overturned Roe v. Wade, allowing states to pass laws [&hellip;]<\/p>\n","protected":false},"author":62,"featured_media":262399,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"om_disable_all_campaigns":false},"categories":[3473,11],"tags":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v20.7 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>FDA changes Plan B label to remove warning that it may cause abortion<\/title>\n<meta name=\"description\" content=\"The FDA has announced it will change the label on Plan B One-Step emergency contraception to say it won&#039;t cause an abortion. But questions remain.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/archive.liveaction.org\/news\/fda-plan-b-label-abortion\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"FDA changes Plan B label to remove warning that it may cause abortion\" \/>\n<meta property=\"og:description\" content=\"The FDA has announced it will change the label on Plan B One-Step emergency contraception to say it won&#039;t cause an abortion. But questions remain.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/archive.liveaction.org\/news\/fda-plan-b-label-abortion\/\" \/>\n<meta property=\"og:site_name\" content=\"Live Action News\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/liveaction\" \/>\n<meta property=\"article:published_time\" content=\"2022-12-29T17:30:11+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2022-12-29T17:10:22+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/archive.liveaction.org\/news\/wp-content\/uploads\/2022\/02\/GettyImages-1223126964-pill.jpg\" \/>\n\t<meta property=\"og:image:width\" content=\"1200\" \/>\n\t<meta property=\"og:image:height\" content=\"650\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/jpeg\" \/>\n<meta name=\"author\" content=\"Nancy Flanders\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:creator\" content=\"@liveaction\" \/>\n<meta name=\"twitter:site\" content=\"@liveaction\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Nancy Flanders\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"4 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\/\/archive.liveaction.org\/news\/fda-plan-b-label-abortion\/#article\",\"isPartOf\":{\"@id\":\"https:\/\/archive.liveaction.org\/news\/fda-plan-b-label-abortion\/\"},\"author\":{\"name\":\"Nancy Flanders\",\"@id\":\"https:\/\/archive.liveaction.org\/news\/#\/schema\/person\/d61ca3dd1aacf12635bdf71d75c328ef\"},\"headline\":\"FDA changes Plan B label to remove warning that it may cause abortion\",\"datePublished\":\"2022-12-29T17:30:11+00:00\",\"dateModified\":\"2022-12-29T17:10:22+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\/\/archive.liveaction.org\/news\/fda-plan-b-label-abortion\/\"},\"wordCount\":807,\"publisher\":{\"@id\":\"https:\/\/archive.liveaction.org\/news\/#organization\"},\"articleSection\":[\"Newsbreak\",\"Politics\"],\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\/\/archive.liveaction.org\/news\/fda-plan-b-label-abortion\/\",\"url\":\"https:\/\/archive.liveaction.org\/news\/fda-plan-b-label-abortion\/\",\"name\":\"FDA changes Plan B label to remove warning that it may cause abortion\",\"isPartOf\":{\"@id\":\"https:\/\/archive.liveaction.org\/news\/#website\"},\"datePublished\":\"2022-12-29T17:30:11+00:00\",\"dateModified\":\"2022-12-29T17:10:22+00:00\",\"description\":\"The FDA has announced it will change the label on Plan B One-Step emergency contraception to say it won't cause an abortion. 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