{"id":286213,"date":"2023-03-04T15:04:51","date_gmt":"2023-03-04T21:04:51","guid":{"rendered":"https:\/\/www.liveaction.org\/news\/?p=286213"},"modified":"2023-03-19T23:54:13","modified_gmt":"2023-03-20T04:54:13","slug":"bad-actors-industry-fda-rules-risking-safety","status":"publish","type":"post","link":"https:\/\/archive.liveaction.org\/news\/bad-actors-industry-fda-rules-risking-safety\/","title":{"rendered":"BAD ACTORS: As abortion industry veers from FDA abortion pill rules, are they risking client safety?"},"content":{"rendered":"<div style=\"margin-top: 0px; margin-bottom: 0px;\" class=\"sharethis-inline-share-buttons\" ><\/div><p><em>Editor&#8217;s Note: This article is the fifth installment in a series. Other articles can be read here: <a href=\"https:\/\/archive.liveaction.org\/news\/bad-actors-industry-abortion-pill-fda-limits\/\">Bad Actors #1<\/a>, <a href=\"https:\/\/archive.liveaction.org\/news\/bad-actors-abortion-pill-fda-ectopic\/\">Bad Actors #2<\/a>, <a href=\"https:\/\/archive.liveaction.org\/news\/bad-actors-failure-prone-abortion-drug\/\">Bad Actors #3<\/a>, <a href=\"https:\/\/archive.liveaction.org\/news\/bad-actors-industry-abortion-pills-arent-pregnant\/\">Bad Actors #4<\/a>,\u00a0<a href=\"https:\/\/archive.liveaction.org\/news\/bad-actors-conceal-abortion-pill-complications\/\">Bad Actors #6<\/a>, <a href=\"https:\/\/archive.liveaction.org\/news\/bad-actors-money-trail-abortion-pill-corruption\/\">Bad Actors #7<\/a>.<\/em><\/p>\n<p>The abortion industry has, for a very long time, stuck to a certain script about how the abortion pill is administered: a woman takes the first drug, mifepristone, by mouth on day one. Then 24-48 hours later, she takes the second drug, misoprostol, placing it inside the cheek pouch of her mouth. This is the FDA-<a href=\"https:\/\/www.fda.gov\/drugs\/postmarket-drug-safety-information-patients-and-providers\/questions-and-answers-mifepristone-medical-termination-pregnancy-through-ten-weeks-gestation\">approved<\/a> process.<\/p>\n<p>But now, the abortion industry is skirting these rules by encouraging\u00a0<em>vaginal<\/em> insertion of misoprostol&#8230; something that was halted years ago when some women contracted a rare infection after using the drug vaginally \u2014\u00a0and died.<\/p>\n<p>The dosing regimen of mifepristone and misoprostol in the abortion pill regimen is below:<\/p>\n<ul role=\"list\">\n<li>On day one: 200 mg of mifepristone taken by mouth.<\/li>\n<li>24 to 48 hours after taking mifepristone: 800 mcg of misoprostol <strong>taken buccally (in the cheek pouch)<\/strong>, at a location appropriate for the patient.<\/li>\n<li>About seven to 14 days after taking mifepristone: follow-up with the health care provider.<\/li>\n<\/ul>\n<div id=\"attachment_285826\" style=\"width: 718px\" class=\"wp-caption aligncenter\"><img aria-describedby=\"caption-attachment-285826\" decoding=\"async\" loading=\"lazy\" class=\" wp-image-285826\" src=\"https:\/\/archive.liveaction.org\/news\/wp-content\/uploads\/2023\/02\/Mifepristone-Jan-2023-label-taking-the-drug.jpg\" alt=\"Image: Mifepristone Jan 2023 label taking the abortion pill\" width=\"708\" height=\"540\" srcset=\"https:\/\/archive.liveaction.org\/news\/wp-content\/uploads\/2023\/02\/Mifepristone-Jan-2023-label-taking-the-drug.jpg 836w, https:\/\/archive.liveaction.org\/news\/wp-content\/uploads\/2023\/02\/Mifepristone-Jan-2023-label-taking-the-drug-300x229.jpg 300w, https:\/\/archive.liveaction.org\/news\/wp-content\/uploads\/2023\/02\/Mifepristone-Jan-2023-label-taking-the-drug-768x585.jpg 768w, https:\/\/archive.liveaction.org\/news\/wp-content\/uploads\/2023\/02\/Mifepristone-Jan-2023-label-taking-the-drug-700x533.jpg 700w, https:\/\/archive.liveaction.org\/news\/wp-content\/uploads\/2023\/02\/Mifepristone-Jan-2023-label-taking-the-drug-500x381.jpg 500w\" sizes=\"(max-width: 708px) 100vw, 708px\" \/><p id=\"caption-attachment-285826\" class=\"wp-caption-text\">Mifepristone Jan 2023 label taking the abortion pill<\/p><\/div>\n<p>Yet, those in the abortion industry, including <a href=\"https:\/\/www.plannedparenthood.org\/learn\/abortion\/the-abortion-pill\/how-do-i-use-abortion-pill\" target=\"_blank\" rel=\"noopener\">Planned Parenthood<\/a>, regularly allow for vaginal insertion of the second drug in the regimen (misoprostol).\u00a0See examples of this\u00a0<a href=\"https:\/\/cwhccolorado.com\/services\/medication-abortion\/aftercare-medication-abortion\/index.html\" target=\"_blank\" rel=\"noopener\">here<\/a>, <a href=\"https:\/\/carafem.org\/abortion-pill\/\" target=\"_blank\" rel=\"noopener\">here<\/a>, and <a href=\"https:\/\/prochoice.org\/wp-content\/uploads\/vaginal_miso.pdf\" target=\"_blank\" rel=\"noopener\">here<\/a>.<\/p>\n<p>In addition, some in the industry are touting a\u00a0&#8216;<u><a href=\"https:\/\/archive.liveaction.org\/news\/abortion-push-same-day-abortion-pill-fda\/\">same-day<\/a>&#8216;<\/u> abortion pill protocol (including <a href=\"https:\/\/archive.liveaction.org\/news\/abortion-push-same-day-abortion-pill-fda\/\" target=\"_blank\" rel=\"noopener\">Planned Parenthood<\/a> facilities) for women traveling from out of state. This protocol also differs from the FDA-approved REMS safety requirements and may be less effective and more risky for women who use it.<\/p>\n<div id=\"attachment_285946\" style=\"width: 489px\" class=\"wp-caption aligncenter\"><img aria-describedby=\"caption-attachment-285946\" decoding=\"async\" loading=\"lazy\" class=\" wp-image-285946\" src=\"https:\/\/archive.liveaction.org\/news\/wp-content\/uploads\/2023\/02\/Flouting-same-day-abortion-pill-late-in-pregnancy-Image-Twitter.jpg\" alt=\"Image: Flouting same day abortion pill late in pregnancy (Image: Twitter)\" width=\"479\" height=\"402\" srcset=\"https:\/\/archive.liveaction.org\/news\/wp-content\/uploads\/2023\/02\/Flouting-same-day-abortion-pill-late-in-pregnancy-Image-Twitter.jpg 587w, https:\/\/archive.liveaction.org\/news\/wp-content\/uploads\/2023\/02\/Flouting-same-day-abortion-pill-late-in-pregnancy-Image-Twitter-300x252.jpg 300w, https:\/\/archive.liveaction.org\/news\/wp-content\/uploads\/2023\/02\/Flouting-same-day-abortion-pill-late-in-pregnancy-Image-Twitter-500x420.jpg 500w\" sizes=\"(max-width: 479px) 100vw, 479px\" \/><p id=\"caption-attachment-285946\" class=\"wp-caption-text\">Offering same day abortion pill late in pregnancy (Image: Twitter)<\/p><\/div>\n<p>The abortion pill was approved in 2000, and almost immediately thereafter the abortion industry began using it\u00a0<a href=\"https:\/\/archive.liveaction.org\/news\/abortion-pill-dangerous-safety-requirement\/\" target=\"_blank\" rel=\"noopener\">off-label.<\/a>\u00a0As a result, multiple women died after contracting a rare infection called\u00a0<em>C. sordellii. <\/em><\/p>\n<p>Notably, vaginal use of the misoprostol has been suggested as a <strong>potential &#8216;causal factor&#8217; in those events<\/strong>, since, according to <a href=\"https:\/\/academic.oup.com\/cid\/article\/43\/11\/1447\/451418\" target=\"_blank\" rel=\"noopener\">one report<\/a>, &#8220;4 women in the United States who developed this condition after medical abortion had used misoprostol vaginally.&#8221; Shortly after these deaths, several abortion providers, including Planned Parenthood, <em>discontinued<\/em> recommending vaginal insertion of misoprostol.<\/p>\n<p><em><strong>Until recently.<\/strong><\/em><\/p>\n<p>Planned Parenthood&#8217;s website now <a href=\"https:\/\/www.plannedparenthood.org\/learn\/abortion\/the-abortion-pill\/how-do-i-use-abortion-pill\" target=\"_blank\" rel=\"noopener\">states<\/a>, &#8220;First, you\u2019ll take a pill called mifepristone. Pregnancy needs a\u00a0hormone\u00a0called\u00a0progesterone\u00a0to grow normally. Mifepristone blocks your body\u2019s own progesterone, stopping the pregnancy from growing&#8230; Then you\u2019ll take the second medicine, misoprostol, <em><strong>either right away<\/strong><\/em>\u00a0[emphasis added] or up to 48 hours later.&#8221;<\/p>\n<p>Clients who want to administer misoprostol immediately are told by Planned Parenthood to insert the drug <em><strong>vaginally<\/strong><\/em>, &#8220;0-48 hours after taking mifepristone.&#8221;<\/p>\n<p>A July of 2022\u00a0<a href=\"https:\/\/www.kwit.org\/spm-news-english\/2022-07-20\/newscast-07-20-22-planned-parenthood-in-sioux-city-makes-changes-to-help-patients-covid-on-the-rise-in-iowa\" target=\"_blank\" rel=\"noopener\">report<\/a>\u00a0from KWIT in Iowa confirmed the existence of this protocol, noting that a Sioux City Planned Parenthood was administering the drug vaginally because it &#8220;doesn\u2019t require patients to wait 24 hours for a second dose of the medication.\u201d<\/p>\n<p>But a separate\u00a0<a href=\"https:\/\/www.washingtonpost.com\/politics\/2022\/08\/25\/national-abortion-federation-restrictions\/\" target=\"_blank\" rel=\"noopener\">report<\/a>\u00a0from the Washington Post regarding a <a href=\"https:\/\/archive.liveaction.org\/news\/national-abortion-federation-abortion-pill-policy-change\/\" target=\"_blank\" rel=\"noopener\">policy change<\/a> by the National Abortion Federation (NAF) pointed out that \u201c[w]hile both abortion pills \u2014 mifepristone and misoprostol \u2014 can be taken at the same time if the misoprostol is taken vaginally, this method is far less popular and would make immediate travel risky, providers say, because the patient could begin passing the pregnancy on their way home.\u201d<\/p>\n<p>According to a chart\u00a0<a href=\"https:\/\/www.acog.org\/clinical\/clinical-guidance\/practice-bulletin\/articles\/2020\/10\/medication-abortion-up-to-70-days-of-gestation\" target=\"_blank\" rel=\"noopener\">published<\/a>\u00a0by the pro-abortion American College of Obstetricians and Gynecologists (ACOG) on \u201cmedication abortion,\u201d the <em>efficacy rate appears to be diminished<\/em> when women take misoprostol vaginally at the same time as mifepristone.<\/p>\n<p>In simpler terms, taking the second drug vaginally appears to increase the risk of an incomplete or failed abortion.<\/p>\n<p><a href=\"https:\/\/www.liveaction.org\/walgreens-cvs-petition\/\"><img decoding=\"async\" loading=\"lazy\" class=\"aligncenter size-large wp-image-283198\" src=\"https:\/\/archive.liveaction.org\/news\/wp-content\/uploads\/2023\/01\/Keep-Abortion-Pill-Out-Of-Walgreens-CVSLAN-Horizontal--700x180.jpg\" alt=\"Walgreens CVS banner\" width=\"700\" height=\"180\" srcset=\"https:\/\/archive.liveaction.org\/news\/wp-content\/uploads\/2023\/01\/Keep-Abortion-Pill-Out-Of-Walgreens-CVSLAN-Horizontal--700x180.jpg 700w, https:\/\/archive.liveaction.org\/news\/wp-content\/uploads\/2023\/01\/Keep-Abortion-Pill-Out-Of-Walgreens-CVSLAN-Horizontal--300x77.jpg 300w, https:\/\/archive.liveaction.org\/news\/wp-content\/uploads\/2023\/01\/Keep-Abortion-Pill-Out-Of-Walgreens-CVSLAN-Horizontal--768x197.jpg 768w, https:\/\/archive.liveaction.org\/news\/wp-content\/uploads\/2023\/01\/Keep-Abortion-Pill-Out-Of-Walgreens-CVSLAN-Horizontal--500x128.jpg 500w\" sizes=\"(max-width: 700px) 100vw, 700px\" \/><\/a><\/p>\n<p>ACOG\u2019s chart (below) shows that when taking misoprostol\u00a0<em>buccally<\/em>\u00a0(in the cheek of the mouth) <em>24-48 hours<\/em>\u00a0after mifepristone, the completion rate is 98.1% (at or less than seven weeks) and drops to 92.7% at 64 to 70 days (or nine to 10 weeks) of pregnancy. Misoprostol taken\u00a0<em>vaginally<\/em>\u00a0at\u00a0<em>24-72 hours<\/em>\u00a0after mifepristone shows an efficacy rate of 98.3% (at or less than seven weeks) and drops to 94.9% at 64 to 70 days (or nine to 10 weeks) of pregnancy.<\/p>\n<p>But when misoprostol is taken vaginally\u00a0<em>at the same time<\/em>\u00a0as mifepristone (0-.25 hours), the failure rate rises and efficacy drops to around 95 or 96%\u00a0(at or less than seven weeks) \u2014 increasing the failure risk \u2014 and decreases even further when using this protocol between eight to nine weeks, ranging from to 91.6 to 95.3% at 63 days (or nine weeks) of pregnancy. The chart did not indicate what the failure rate would even be at 10 or more weeks, writing \u201cN\/A.\u201d<\/p>\n<p>This is problematic, as most Planned Parenthood and other\u00a0<a href=\"http:\/\/aidtowomencenter.org\/abortion-firsttrimester\" target=\"_blank\" rel=\"noopener\">abortion facilities<\/a>\u00a0are selling abortion pills well past the FDA-approved 10-week cutoff.\u00a0The abortion pill\u00a0has been a\u00a0<a href=\"https:\/\/archive.liveaction.org\/news\/industry-sales-300m-abortion-pill\/\" target=\"_blank\" rel=\"noopener\">boon<\/a>\u00a0for the\u00a0<a href=\"https:\/\/archive.liveaction.org\/news\/abortion-industry-6-ways-cashing-in-pill-bilking\/\" target=\"_blank\" rel=\"noopener\">industry<\/a>. As of 2020, the abortion pill made up\u00a0<a href=\"https:\/\/archive.liveaction.org\/news\/500k-preborn-human-abortion-pill-2020\/\" target=\"_blank\" rel=\"noopener\">more than half (53%)<\/a>\u00a0of all abortions committed in the United States.<\/p>\n<div id=\"attachment_275306\" style=\"width: 748px\" class=\"wp-caption aligncenter\"><img aria-describedby=\"caption-attachment-275306\" decoding=\"async\" loading=\"lazy\" class=\"wp-image-275306\" src=\"https:\/\/archive.liveaction.org\/news\/wp-content\/uploads\/2022\/09\/ACOG-medication-abortion-interval-between-Mifepristone-and-Misoprostol-accessed-09012022.jpg\" alt=\"Image: ACOG medication abortion interval between Mifepristone and Misoprostol accessed 09012022\" width=\"738\" height=\"611\" srcset=\"https:\/\/archive.liveaction.org\/news\/wp-content\/uploads\/2022\/09\/ACOG-medication-abortion-interval-between-Mifepristone-and-Misoprostol-accessed-09012022.jpg 816w, https:\/\/archive.liveaction.org\/news\/wp-content\/uploads\/2022\/09\/ACOG-medication-abortion-interval-between-Mifepristone-and-Misoprostol-accessed-09012022-300x249.jpg 300w, https:\/\/archive.liveaction.org\/news\/wp-content\/uploads\/2022\/09\/ACOG-medication-abortion-interval-between-Mifepristone-and-Misoprostol-accessed-09012022-768x636.jpg 768w, https:\/\/archive.liveaction.org\/news\/wp-content\/uploads\/2022\/09\/ACOG-medication-abortion-interval-between-Mifepristone-and-Misoprostol-accessed-09012022-700x580.jpg 700w, https:\/\/archive.liveaction.org\/news\/wp-content\/uploads\/2022\/09\/ACOG-medication-abortion-interval-between-Mifepristone-and-Misoprostol-accessed-09012022-500x414.jpg 500w\" sizes=\"(max-width: 738px) 100vw, 738px\" \/><p id=\"caption-attachment-275306\" class=\"wp-caption-text\">ACOG medication abortion interval between Mifepristone and Misoprostol accessed 09012022<\/p><\/div>\n<p>In addition, Planned Parenthood of Illinois\u2019\u00a0<a href=\"https:\/\/www.plannedparenthood.org\/uploads\/filer_public\/2d\/3f\/2d3f0669-b2bd-4a15-8b78-b648281bf2a4\/mab020_how_to_take_your_pills_info_aftercare_and_follow_up.pdf?fbclid=IwAR2HFBnNMjP069q-iF5CANjOc4PRJOS0QQNSoXR24XyoKNaiC-oVEZlAXRo\" target=\"_blank\" rel=\"noopener\">instruction and aftercare document<\/a>\u00a0on medication abortion clearly warns, \u201cIf you take mifepristone Day 71-77, you cannot use misoprostol vaginally.\u201d<\/p>\n<div id=\"attachment_275308\" style=\"width: 695px\" class=\"wp-caption aligncenter\"><img aria-describedby=\"caption-attachment-275308\" decoding=\"async\" loading=\"lazy\" class=\"wp-image-275308\" src=\"https:\/\/archive.liveaction.org\/news\/wp-content\/uploads\/2022\/09\/Planned-Parenthood-April-2022-doc-on-abortion-pill.jpg\" alt=\"Image: Planned Parenthood April 2022 doc on abortion pill\" width=\"685\" height=\"608\" srcset=\"https:\/\/archive.liveaction.org\/news\/wp-content\/uploads\/2022\/09\/Planned-Parenthood-April-2022-doc-on-abortion-pill.jpg 993w, https:\/\/archive.liveaction.org\/news\/wp-content\/uploads\/2022\/09\/Planned-Parenthood-April-2022-doc-on-abortion-pill-300x266.jpg 300w, https:\/\/archive.liveaction.org\/news\/wp-content\/uploads\/2022\/09\/Planned-Parenthood-April-2022-doc-on-abortion-pill-768x681.jpg 768w, https:\/\/archive.liveaction.org\/news\/wp-content\/uploads\/2022\/09\/Planned-Parenthood-April-2022-doc-on-abortion-pill-700x621.jpg 700w, https:\/\/archive.liveaction.org\/news\/wp-content\/uploads\/2022\/09\/Planned-Parenthood-April-2022-doc-on-abortion-pill-500x444.jpg 500w\" sizes=\"(max-width: 685px) 100vw, 685px\" \/><p id=\"caption-attachment-275308\" class=\"wp-caption-text\">Planned Parenthood April 2022 doc on abortion pill<\/p><\/div>\n<p>Whether or not vaginal use of misoprostol led to the deaths previously mentioned, the FDA protocol calls for misoprostol to be used buccally, in the checks of the mouth, <em>not vaginally<\/em>. This is yet one more way the abortion industry does not strictly comply with the FDA safety requirements and\u00a0continues to flout the REMS without any sanctions whatsoever.<\/p>\n<p style=\"text-align: center;\"><a href=\"https:\/\/give.liveaction.org\/general-donation\/?utm_source=lan&amp;utm_medium=display&amp;utm_campaign=monthly&amp;utm_content=article\"><i><strong>Did you know that as little as $10 a month is enough to reach more than 3,000 people with the truth about abortion that no one else is telling them? Click here to start saving lives 365 days a year.<\/strong><\/i><\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Editor&#8217;s Note: This article is the fifth installment in a series. Other articles can be read here: Bad Actors #1, Bad Actors #2, Bad Actors #3, Bad Actors #4,\u00a0Bad Actors #6, Bad Actors #7. The abortion industry has, for a very long time, stuck to a certain script about how the abortion pill is administered: [&hellip;]<\/p>\n","protected":false},"author":303,"featured_media":257603,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"om_disable_all_campaigns":false},"categories":[9953],"tags":[19887],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v20.7 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>BAD ACTORS: As abortion industry veers from FDA abortion pill rules, are they risking client safety?<\/title>\n<meta name=\"description\" content=\"The abortion industry is skirting FDA rules by encouraging\u00a0vaginal insertion of misoprostol... which had been halted years ago when some women died.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" 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