{"id":239019,"date":"2021-02-05T15:37:17","date_gmt":"2021-02-05T21:37:17","guid":{"rendered":"https:\/\/www.liveaction.org\/news\/?p=239019"},"modified":"2021-07-01T16:57:41","modified_gmt":"2021-07-01T21:57:41","slug":"study-abortion-pill-complications-underreported-er-managing","status":"publish","type":"post","link":"https:\/\/archive.liveaction.org\/news\/study-abortion-pill-complications-underreported-er-managing\/","title":{"rendered":"Study suggests abortion pill complications are underreported, and ERs are managing the majority"},"content":{"rendered":"<div style=\"margin-top: 0px; margin-bottom: 0px;\" class=\"sharethis-inline-share-buttons\" ><\/div><p>Abortion pill clients experiencing a complication are more likely to receive care from an emergency center than the abortion facility where they obtained the pills, according to an analysis of adverse events\u00a0<a href=\"https:\/\/www.fda.gov\/drugs\/questions-and-answers-fdas-adverse-event-reporting-system-faers\/fda-adverse-event-reporting-system-faers-public-dashboard\" target=\"_blank\" rel=\"noopener\">reports<\/a>\u00a0(AERs) submitted to the Food and Drug Administration (FDA) by <a href=\"https:\/\/archive.liveaction.org\/news\/abortion-pill-dangerous-safety-requirement\/\" target=\"_blank\" rel=\"noopener\">abortion pill<\/a>\u00a0manufacturer\u00a0Danco.<\/p>\n<p>A team of over 30 board certified physicians spent three years reviewing thousands of pages of AERs and discovered glaring deficiencies in reporting on abortion pill complications and deaths. They also found that more than 60% of the surgeries due to abortion pill complications were <em>not<\/em> handled by the abortion facility, increasing the potential for large amounts of underreported complications.<\/p>\n<p><a href=\"https:\/\/issuesinlawandmedicine.com\/wp-content\/uploads\/2021\/01\/Deaths-and-Severe-Adverse-Events-after-the-use-of-Mifepristone-as-an-Abortifacient-from-September-2000-to-February-2019-copy5.pdf\" target=\"_blank\" rel=\"noopener\">Published<\/a>\u00a0by\u00a0Issues in Law &amp; Medicine, \u201c<a href=\"https:\/\/issuesinlawandmedicine.com\/wp-content\/uploads\/2021\/01\/Deaths-and-Severe-Adverse-Events-after-the-use-of-Mifepristone-as-an-Abortifacient-from-September-2000-to-February-2019-copy5.pdf\" target=\"_blank\" rel=\"noopener\">Deaths and Severe Adverse Events after the use of Mifepristone as an Abortifacient from September 2000 to February 2019<\/a>,\u201d sheds doubt on whether deaths and adverse events are being properly tracked. The authors of the study included researchers from the American Association of Pro-Life Obstetricians and Gynecologists (AAPLOG).\u00a0\u201c[T]he analysis of the AERs revealed glaring deficiencies\u2026 Throughout the reports, there was also a lack of detail and many patients who were simply \u2018lost to follow-up,&#8217;\u201d the authors wrote.<\/p>\n<p>Due to the\u00a0<a href=\"https:\/\/archive.liveaction.org\/news\/abortion-pill-dangerous-safety-requirement\/\" target=\"_blank\" rel=\"noopener\">dangers<\/a>\u00a0posed by the abortion pill, the FDA put in place a safety system called REMS.\u00a0While anyone can submit an AER, the FDA currently\u00a0<a href=\"https:\/\/www.fda.gov\/drugs\/postmarket-drug-safety-information-patients-and-providers\/questions-and-answers-mifeprex\" target=\"_blank\" rel=\"noopener\">requires<\/a>\u00a0AERs on the abortion pill (Mifeprex or mifepristone) to be submitted by Danco Laboratories, Inc. or by the abortion pill&#8217;s generic manufacturer, GenBioPro.<\/p>\n<p><strong>More ERs are treating complications than abortionists, which means\u00a0complications may go unreported<\/strong><\/p>\n<p>The study found a greater percentage of emergency rooms were treating abortion pill complications than abortion facilities. And, since abortion pill complications are only reported to FDA once the prescriber (abortion facility) or Danco becomes aware, it is likely many complications are falling through the cracks unreported.\u00a0Interestingly, Live Action News has documented how the abortion industry has <a href=\"https:\/\/archive.liveaction.org\/news\/abortion-groups-tell-women-lie-miscarriage\/\">advised women<\/a> to present to ERs claiming <em>miscarriage<\/em> if they experience abortion pill complications.<\/p>\n<p>Equally as troubling is that there is <em><a href=\"https:\/\/archive.liveaction.org\/news\/28-states-require-abortion-complications-reported\/\">no federal mandate<\/a> to report abortion-related complications<\/em> across all 50 states.<\/p>\n<p>AAPLOG\u2019s executive director Dr. Donna Harrison and her team found that\u00a0less than half of the women who experienced a complication received follow-up care from their abortion providers. Dr. Harrison said the AER reports indicated that \u201c[m]ost of the time the women had to resort to the ER to get their care. And often it was after multiple visits to the abortion clinic.&#8221;<\/p>\n<p>Reports suggested abortionists were often <em>unaware<\/em> of complications unless women returned to the abortion facility. As such, they would be unlikely to file reports in those instances.<\/p>\n<p style=\"text-align: center;\"><iframe loading=\"lazy\" src=\"https:\/\/www.youtube.com\/embed\/lRDnVSMr5j0\" width=\"640\" height=\"355\" frameborder=\"0\" allowfullscreen=\"allowfullscreen\"><span data-mce-type=\"bookmark\" style=\"display: inline-block; width: 0px; overflow: hidden; line-height: 0;\" class=\"mce_SELRES_start\">\ufeff<\/span><\/iframe><\/p>\n<p>\u201cThe information in the AERs is almost exclusively obtained from abortion providers, rather than the physician treating the complication, yet in this analysis, abortion providers managed only 39.75% of surgical complications (a number which is likely much lower since these are only the cases which are known to the abortion provider). Throughout the reports, there was also a lack of detail and many patients who were simply &#8216;lost to follow-up,&#8221; the authors wrote.<\/p>\n<p>According to Dr. Harrison, &#8220;surgical complications&#8221; included a failed abortion requiring a complete D&amp;C, an incomplete abortion (tissue left inside), a missed ectopic pregnancy and in a small number of cases, overwhelming infection leading to hysterectomies.<\/p>\n<p>&#8220;Many of the AEs [adverse events] experienced by women were unknown to the abortion provider until the follow-up examination, which is troubling considering the poor follow-up rate and elimination of the requirement for an in-office follow up visit. <em><strong>Some of the patient deaths were not known to the abortion provider until they saw the death in an obituary or were contacted by an outside source<\/strong><\/em>,&#8221; the authors stated (emphasis added).<\/p>\n<p>&#8220;Because of this, in addition to abortion providers, hospitals, emergency departments, and private practitioners should be required to report AEs,&#8221; the authors suggested.<\/p>\n<p><strong>How many women present to ERs for abortion complications?<\/strong><\/p>\n<p>\u201cWe know from other studies that about five percent of women end up in the emergency room,\u201d Dr. Harrison stated.<\/p>\n<p>Pro-abortion ER doctor\u00a0<a href=\"https:\/\/www.youtube.com\/watch?v=8JZBzhk8Mzs\">Dara Kass<\/a>\u00a0confirmed this fact when she stated that eight percent of abortion pill patients end up in the ER. In 2019, Kass told <a href=\"https:\/\/www.vice.com\/en\/article\/ne8m48\/emergency-room-doctors-need-to-know-more-about-self-managed-abortion-with-pills\" target=\"_blank\" rel=\"noopener\">Vice News<\/a>, &#8220;[&#8230;] when patients are scared, or have pain or bleeding, they come to me.&#8221;\u00a0She then pointed out, \u201cRecently\u00a0<a href=\"https:\/\/www.sciencedirect.com\/science\/article\/abs\/pii\/S0010782419301763\" target=\"_blank\" rel=\"noopener\">published<\/a>\u00a0results of the Gynuity pilot project showed that 8 percent of their patients who received abortion medication sought follow-up care at a local urgent care clinic or emergency department.\u201d<\/p>\n<p>Five to eight percent is no small number and may represent anywhere from 17,000 to 27,000 possible emergency or urgent care visits in <em>one year,<\/em> based off the most recent data\u00a0(<a href=\"https:\/\/www.guttmacher.org\/sites\/default\/files\/report_pdf\/abortion-incidence-service-availability-us-2017.pdf\" target=\"_blank\" rel=\"noopener\">2017)<\/a>\u00a0showing\u00a0339,640\u00a0medication abortions were committed nationally out of 862,320 total abortions\u00a0<a href=\"https:\/\/archive.liveaction.org\/news\/us-abortion-rate-lowest-roe-v-wade\/\" target=\"_blank\" rel=\"noopener\">reported<\/a>.<\/p>\n<p>The question is, <em>where are all those complication reports? <\/em>Women are being misled. It is <a href=\"https:\/\/archive.liveaction.org\/news\/cecile-richards-abortion-pill-safer\/\">not as safe<\/a> as <a href=\"https:\/\/archive.liveaction.org\/news\/abortion-pill-not-tylenol-parents-know-minors\/\">the abortion industry claims<\/a>.<\/p>\n<p style=\"text-align: center;\"><iframe loading=\"lazy\" src=\"https:\/\/www.youtube.com\/embed\/FSK9ptRccYM\" width=\"640\" height=\"355\" frameborder=\"0\" allowfullscreen=\"allowfullscreen\"><span data-mce-type=\"bookmark\" style=\"display: inline-block; width: 0px; overflow: hidden; line-height: 0;\" class=\"mce_SELRES_start\">\ufeff<\/span><\/iframe><\/p>\n<p><strong>Uncodable reports\u00a0<\/strong><\/p>\n<p>Dr. Harrison said her team of researchers\u00a0found the information they reviewed to have scant details, and she described many of the AER reports as &#8220;uncodable.&#8221;\u00a0Some indicated emergencies that did not specify whether the woman\u00a0lived or died.<\/p>\n<p>\u201cNo tests, no examination, no vital signs, no follow-up,\u201d she described them.\u00a0\u201cMost of these reports we called \u2018uncodable,\u2019 and they were likely life threatening.\u00a0We called these uncodable because there was no way to find out how sick she was or how much she hemorrhaged or how much blood was needed to save her life,\u201d Harrison added. \u201cAnd there\u2019s no way that the FDA could tell that, either.\u201d<\/p>\n<p><strong>Deaths and Complications<\/strong><\/p>\n<p>Live Action News has previously documented that, as of December 31, 2018, there were 24 women reported to have died from the abortion pill since its approval in 2000, \u201cincluding two cases of ectopic pregnancy resulting in death; and several cases of severe systemic infection (also called sepsis), including some that were fatal,\u201d the FDA\u2019s\u00a0<a href=\"https:\/\/www.fda.gov\/drugs\/postmarket-drug-safety-information-patients-and-providers\/questions-and-answers-mifeprex\" target=\"_blank\" rel=\"noopener\">website<\/a>\u00a0states.<\/p>\n<p>The FDA also\u00a0<a href=\"https:\/\/www.fda.gov\/media\/112118\/download\" target=\"_blank\" rel=\"noopener\">found<\/a> nearly 4,200 adverse events including 1,042 hospitalizations and nearly 600 serious cases of blood loss along with over 400 cases of infection.<\/p>\n<p>Despite thousands of adverse events and deaths,\u00a0<a href=\"https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/nda\/2016\/020687Orig1s020RemsR.pdf\">changes<\/a>\u00a0made by the FDA in 2016 no longer required\u00a0<a href=\"https:\/\/archive.liveaction.org\/news\/secrecy-abortion-pill-maker-investors\/\">Danco<\/a>\u00a0to\u00a0<a href=\"https:\/\/archive.liveaction.org\/news\/pro-abortion-men-legalize-expand-abortion\/\">report<\/a><i>\u00a0non-fatal adverse effects,\u00a0<\/i>so the true complication numbers are not known. In addition, despite numerous requests to the FDA and a requirement that Danco and GenBioPro report all known deaths, Live Action News has been unable to obtain more recent data.<\/p>\n<p><strong>Compromised and inadequate complication reports<\/strong><\/p>\n<p>The most important findings the researchers discovered, according to Dr. Harrison, was that the current FDA system to determine the safety of drugs like the abortion pill is inadequate.<\/p>\n<p>The information given to the FDA was \u201ccompromised\u201d and significantly underestimated the adverse events from mifepristone, Dr. Harrison said. In many cases, the researchers who reviewed reports found there was minimal to nonexistent clinical information for which to judge the severity of the events.\u00a0Dr. Harrison suggested the reports may be filtered by the abortion pill manufacturer\u00a0from an industry which has no motivation for accuracy.<\/p>\n<p>\u201cWe found that almost one of six of the&#8230; reports didn\u2019t even have enough information to tell the FDA or anyone else what actually happened to the woman. The FDA could not have used these reports to reassure anyone that Mifeprex is safe,\u201d Dr. Harrison emphasized.\u00a0\u201cWe are left with the sobering conclusion that the FDA now has no real-world idea of the number of women who are dead or injured from Mifeprex abortions.&#8221;<\/p>\n<p>Dr. Harrison predicted the push to demedicalize abortion and lift REMS so women can obtain the abortion pill online, at a pharmacy, or over the counter would only serve to worsen the problem of faulty reporting.\u00a0\u201cMore women will suffer complications invisible to oversight,\u201d she said.<\/p>\n<p>As such, AAPLOG is calling for the FDA to strengthen not weaken or eliminate the REMS on the abortion pill. In addition, they are also calling for mandatory abortion complication reporting to be implemented at the federal level for the safety of women.<\/p>\n<p><em>Editor&#8217;s Note: For information on abortion pill reversal, visit <a href=\"http:\/\/abortionpillreversal.com\">AbortionPillRescue<\/a>.<\/em><\/p>\n<p><em><strong>Editor&#8217;s Note, 4\/18\/21<\/strong>:\u00a0The FDA has received reports of serious adverse events in women who took Mifeprex. As of December 31, 2018, there were reports of 24 deaths of women associated with Mifeprex since the product was approved in September 2000, including two cases of ectopic pregnancy resulting in death; and several cases of severe systemic infection (also called sepsis), including some that were fatal.\u00a0<\/em><\/p>\n<p><em>The adverse events cannot with certainty be causally attributed to mifepristone because of concurrent use of other drugs, other medical or surgical treatments, co-existing medical conditions, and information gaps about patient health status and clinical management of the patient. A summary report of adverse events that reflects data through December 31, 2018 is <a href=\"https:\/\/www.fda.gov\/drugs\/postmarket-drug-safety-information-patients-and-providers\/questions-and-answers-mifeprex\">here<\/a>.<\/em><\/p>\n<p style=\"text-align: center;\"><em><strong><a href=\"https:\/\/www.facebook.com\/liveactionnewsonline\/\">\u201cLike\u201d Live Action News on Facebook<\/a> for more pro-life news and commentary!<\/strong><\/em><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Abortion pill clients experiencing a complication are more likely to receive care from an emergency center than the abortion facility where they obtained the pills, according to an analysis of adverse events\u00a0reports\u00a0(AERs) submitted to the Food and Drug Administration (FDA) by abortion pill\u00a0manufacturer\u00a0Danco. A team of over 30 board certified physicians spent three years reviewing [&hellip;]<\/p>\n","protected":false},"author":303,"featured_media":239343,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"om_disable_all_campaigns":false},"categories":[9953,15,9459],"tags":[2386,1908,8915,6748],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v20.7 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Study suggests abortion pill complications are underreported, and ERs are managing the majority<\/title>\n<meta name=\"description\" content=\"More ERs are treating abortion pill complications than abortion facilities, but complications are only reported to the FDA by prescribers or manufacturers.\" \/>\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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