{"id":224817,"date":"2020-06-06T14:30:13","date_gmt":"2020-06-06T19:30:13","guid":{"rendered":"https:\/\/www.liveaction.org\/news\/?p=224817"},"modified":"2024-07-25T19:04:09","modified_gmt":"2024-07-26T00:04:09","slug":"abortion-pill-dangerous-safety-requirement","status":"publish","type":"post","link":"https:\/\/archive.liveaction.org\/news\/abortion-pill-dangerous-safety-requirement\/","title":{"rendered":"The abortion pill: So dangerous it needs a rare safety requirement"},"content":{"rendered":"
<\/div>

UPDATE, 1\/6\/23<\/strong>: On\u00a0January 3, 2023<\/a>, the Biden FDA moderated the REMS safety requirements for the\u00a0abortion pill to allow the deadly drug to be\u00a0sold through retail pharmacies<\/a>\u00a0with a prescription.<\/p>\n

As of\u00a0June 30, 2022<\/a>, U.S. sales of the abortion pill have\u00a0now ended the lives of 5.6 million babies in the U.S. since its approval in 2000, according to\u00a0updated<\/a>\u00a0data\u00a0published<\/a>\u00a0by the FDA. In addition, the updated data reveals that\u00a0there have now been\u00a028 reports of deaths<\/a>\u00a0in patients associated with mifepristone since the product was approved in September 2000. The updated\u00a0data<\/a> also\u00a0showed<\/a>\u00a0there have\u00a0been 4,203 adverse events, including 1,048 hospitalizations, nearly 604 instances of blood loss requiring transfusions, and other serious complications\u00a0reported, including 414 infections, with 71 being categorized as \u201csevere based on medical review of the available case details.\u201d*<\/p>\n

UPDATE, 12\/17\/21<\/strong>:\u00a0In 2021, the abortion pill saw its 21st anniversary<\/a>\u00a0since its approval in 2000, with an increased number of abortion industry schemes flouting<\/a> FDA’s safety regulations.\u00a0The push to lift the REMS continued despite reasons to question<\/a> the abortion pill’s safety.<\/p>\n

In\u00a0April of 2021<\/a>, the Biden Administration\u2019s FDA temporarily enabled abortion pill distribution by mail during the\u00a0COVID-19 pandemic<\/a>.\u00a0Then on December 16, 2021 the FDA ruled<\/a> to remove the in-person requirements and permanately\u00a0allow the abortion pill to be shipped by mail.<\/p>\n

As of June 30, 2021<\/a> the FDA reported mifepristone had\u00a0caused<\/a>\u00a026 deaths and\u00a0tragically revealed that\u00a0an \u201cestimated number of women who have used mifepristone in the U.S. for medical termination of pregnancy\u00a0through the end of June 2021 is approximately 4.9 million women.<\/p>\n

Despite the removal of a reporting requirement for adverse events (aside from death) since 2016, the FDA report<\/a> also\u00a0showed that\u00a04,207 adverse effects had been reported since the\u00a0pill was approved. These include 1,045 hospitalizations. 603 instances of blood loss requiring transfusions, and 413 infections with 70 being categorized as \u201csevere\u00a0based on medical review of the available case details.\u201d<\/p>\n

6\/6\/20<\/strong>: In the 20 years since its approval, the abortion pill has been responsible for the deaths of dozens of women and has caused thousands of serious\u00a0adverse effects<\/a>. Yet these complications appear to go unnoticed, and now the abortion industry is unleashing every arsenal they have to pressure the Food and Drug Administration (FDA) to remove an important safety requirement for the abortion pill.<\/p>\n

The\u00a0Risk Evaluation and Mitigation System<\/a> (REMS)\u00a0requires that mifepristone — one of the two drugs in the abortion pill protocol — \u201cmust be dispensed to patients only in certain healthcare settings, specifically clinics, medical offices, and hospitals, by or under the supervision of a certified prescriber.\u201d According to the FDA<\/a>, REMS is a “drug safety program that the… FDA can require for certain medications with serious safety concerns.” Only a few medications actually require REMS, but amid the COVID-19 pandemic, the abortion industry has focused more of its efforts on pushing for DIY, at-home abortions. That can’t happen if REMS continues to apply to mifepristone. Although this safety requirement exists to protect women<\/em>, abortion advocates have now sued to end REMS for the abortion pill so women can access chemical abortions at home without medical personnel present.<\/p>\n

The Abortion Pill Backstory<\/h4>\n

In what appears to be a very politicized process<\/a>, the abortion pill — RU-486 — was approved in 2000<\/a>\u00a0by the FDA.\u00a0Tragically, shortly after the pill was approved in the U.S., women began dying.<\/p>\n

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<\/div>\n<\/div>\n
\"Image:

Deaths prompt abortion pill warning (Image: Portsmouth Herald 2005 )<\/p><\/div>\n

2001<\/strong>:<\/h4>\n

On September 1, 2001, a woman in Canada<\/a>\u00a0died after taking the abortion pill. Her story barely made headlines, but her cause of death was toxic shock syndrome from a serious\u00a0Clostridium sordellii<\/em>\u00a0infectio<\/a>n<\/a>\u00a0that developed after taking the abortion pill.<\/p>\n

2002<\/strong>:<\/h4>\n

By 2002, the\u00a0FDA<\/a>\u00a0had been informed of postmarketing adverse events which included cases of ruptured ectopic pregnancy \u2013 one case resulting in death, severe systemic infection (sepsis) and a single case of a heart attack. The FDA identified off-label use of misoprostol given vaginally, not orally. Danco then\u00a0published<\/a>\u00a0a \u201cDear Healthcare Provider\u201d letter (see below), to warn of the risk.<\/p>\n

\n
\"Image:

Danco Dear HC Provider letter warns that abortion pill not treatment for ectopic pregnancy 2002<\/p><\/div>\n

2003<\/strong>:<\/h4>\n<\/div>\n

Planned Parenthood\u2019s implementation of the\u00a0unapproved\u00a0regimen<\/a>\u00a0and\u00a0off-label<\/a>\u00a0use of the abortion pill led to the\u00a0death<\/a>\u00a0of 18-year-old Holly Patterson<\/a>\u00a0from\u00a0septic shock<\/a>.<\/p>\n

Patterson\u2019s father Monty\u00a0told<\/a>\u00a0reporters:<\/p>\n

\n

I learned of 10 reported deaths from sepsis (serious infection involving the blood) following medical abortions, and nine of these were from Clostridium sordelli and all involved these alternative, off-label treatments\u2026 That day in the hospital, there were officials from Planned Parenthood who showed up and said that nothing like this had happened before. I just didn\u2019t believe it.<\/em><\/p>\n<\/blockquote>\n

\n
\"Image:

Monty Patterson holds up picture of his daughter Holly who died after taking abortion pill at Planned Parenthood<\/p><\/div>\n<\/div>\n

2004<\/strong>:<\/h4>\n

By 2004, the FDA\u00a0announced<\/a>\u00a0new safety changes to Danco\u2019s\u00a0labeling<\/a>\u00a0of mifepristone. The\u00a0warnings\u00a0added new information on the risk of serious bacterial infections, sepsis, and bleeding and death. The label warned abortionists to be on alert\u00a0for patients with undiagnosed ectopic pregnancies and told women\u00a0to contact providers if they experienced fever, severe abdominal pain, and heavy bleeding.<\/p>\n

Danco issued a second\u00a0letter of warning<\/a>, one to healthcare professionals<\/a> and another to emergency room providers<\/a>, and\u00a0the\u00a0warnings<\/a>\u00a0also advised ER physicians that women who have obtained chemical abortions may present to the ER with these symptoms.<\/p>\n

2005:<\/strong><\/h4>\n

In January 2005, Danco had provided additional information about the complications of abortion to all emergency room physicians and providers of the abortion pill. In July of 2005, the FDA issued a Public Health Advisory<\/a>\u00a0noting several deaths that\u00a0“involve the off-label dosing regimen…” By\u00a0November 2005<\/a>, the FDA\u00a0identified<\/a>\u00a0\u201cfour cases of deaths from infection from September 2003 to June 2005 following medical abortion with these drugs.\u201d The FDA then\u00a0updated the label<\/a>\u00a0and issued another\u00a0Public Health Advisory<\/a>\u00a0\u201chighlighting the risk of sepsis or blood infection when undergoing medical abortion\u2026in a manner that is not consistent with the approved labeling.\u201d<\/p>\n

\n
\"Image:

2005 FDA Public Health Advisory on several abortion pill deaths<\/p><\/div>\n

\n<\/div>\n

That same year,\u00a0the pro-abortion journal Contraception published a\u00a0letter<\/a>\u00a0from abortionist Dr.\u00a0Philip Darney<\/a>, \u201cDeaths associated with medication abortion<\/a>,\u201d\u00a0warning that the\u00a0death rate from the abortion pill among Planned Parenthood patients had reached \u201c1.5 per 100,000 compared to a U.S. rate of .5 for early surgical abortion.\u201d Darney served<\/a>\u00a0on the\u00a0boards<\/a>\u00a0of Planned Parenthood Federation of America and the Guttmacher Institute, Planned Parenthood\u2019s former\u00a0research arm<\/a>.\u00a0In his letter, Darney pointed out that the U.S. death rate using the abortion pill was higher than in Europe, possibly because in the states, \u201cUS Physicians do not follow the FDA approved instructions for using both drugs.”<\/p>\n

\n
\n
\"Image:

Philip D Darney on abortion pill deaths Planned Parenthood and evidence based protocols (Image credit: Journal Contraception)<\/p><\/div>\n

\n<\/div>\n<\/div>\n

Years later, a 2014 Contraception article, entitled \u201cReduction in infection-related mortality since modifications in the regimen of medical abortion,<\/a>\u00a0identified \u201coff-label\u201d use of the abortion pill as a cause of the deaths. The\u00a0authors,<\/a>\u00a0including Planned Parenthood\u2019s own Medical Director Deborah Nucatola, identified how from 2001 to March 2006 Planned Parenthood provided chemical abortions by a regimen of oral mifepristone followed by vaginal misoprostol. They added, \u201cIn response to concerns about serious infections, in early 2006 Planned Parenthood changed the route of misoprostol administration to buccal [the FDA approved method at that time] and required either routine antibiotic coverage or universal screening and treatment for chlamydia; in July 2007, Planned Parenthood began requiring routine antibiotic coverage for all medical abortions.\u201d This change reduced the mortality rate significantly, they claimed.<\/p>\n

\"Image:

2005 abortion pill deaths (Image: The Times-Reporter)<\/p><\/div>\n

2006<\/strong>:<\/h4>\n

In 2006, the\u00a0FDA<\/a>\u00a0became aware of two additional deaths following the abortion pill regimen and in March it issued a\u00a0Public Health Advisory<\/a>\u00a0to warn the public of the risk of sepsis<\/a>\u00a0associated with the abortion pill and announcing two additional deaths from the abortion pill.<\/p>\n

\"Image:

2006 Abortion pill deaths (Image: Nashua Telegraph)<\/p><\/div>\n

On May 11, 2006<\/a>, the FDA, in conjunction with the Centers for Disease Control and Prevention (CDC) and the National Institute of Allergy and Infectious Diseases (NIAID), conducted a public workshop entitled, \u201cEmerging Clostridial Disease,\u201d during which they\u00a0discussed<\/a> the scientific and medical circumstances associated with reports of morbidity and mortality with\u00a0Clostridium sordellii<\/em>\u00a0and\u00a0Clostridium difficile<\/em>\u00a0infections connected to chemical abortions.<\/p>\n

2007:<\/strong><\/h4>\n

By 2007, the FDA\u00a0published<\/a>\u00a0that it had identified six deaths from serious infection since the abortion pill was approved.<\/p>\n

2010<\/strong>:<\/h4>\n

By\u00a02010, the FDA identified<\/a> \u201coff label\u201d use of the abortion pill as the cause of\u00a0several serious adverse effects, including death. The FDA noted, \u201cSince the approval of Mifeprex\u2026FDA has been informed of eight deaths<\/strong><\/em> in the United States due to serious infections following medical abortion with mifepristone and misoprostol that FDA has concluded may possibly be related to the use of these drugs.\u00a0 These women died from sepsis\u2026Seven cases were found to involve infection with bacteria known as\u00a0Clostridium sordellii<\/em>\u00a0and one case involved infection with\u00a0Clostridium perfringens<\/em>.\u201d<\/p>\n

2011:<\/strong><\/h4>\n

By\u00a0April 2011, the FDA\u00a0reported<\/a>\u00a0over 2,200 adverse effects. Post-marketing reports\u00a0show<\/a>\u00a014 women had died, 612 were hospitalized, 339 women had experienced blood loss which required transfusions, as well as several hundred reported cases of infection, some severe.<\/p>\n

It was in this year<\/em> that the FDA determined<\/a> that a REMS<\/a>\u00a0was necessary<\/em> for mifepristone.<\/p>\n

\"Image:

FDA REMS defined as of 6\/3\/2020<\/p><\/div>\n

2016:<\/strong><\/h4>\n

Despite thousands of adverse effects and additional deaths,\u00a0changes<\/a>\u00a0made in 2016 no longer required\u00a0Danco<\/a>\u00a0to\u00a0report<\/a>\u00a0non-fatal adverse effects.\u00a0<\/i>While the abortion industry successfully lobbied to absolve their industry and the manufacturer of any responsibility to report adverse effects, it is still advisable for women or emergency room physicians to\u00a0report<\/a>\u00a0incidents to the FDA\u00a0directly. That same year, the FDA also noted<\/a>, “after reviewing the supplemental application, the agency determined that a\u00a0REMS<\/a>\u00a0continues to be necessary to ensure the safe use of Mifeprex.”<\/p>\n

2017<\/strong>:<\/h4>\n

By December 31, 2017, the\u00a0FDA<\/a>\u00a0had reported 22 deaths as well as serious complications, associated with the abortion pill.<\/p>\n

\"Image:

RU486 abortion pill serious adverse effects updated 2017<\/p><\/div>\n

2018<\/strong>:<\/p>\n

In\u00a0December of 2018<\/a>, the FDA\u00a0reported<\/a>\u00a024 deaths<\/b>\u00a0associated with the abortion pill since its approval. Abortion pills have\u00a0caused<\/a>\u00a0nearly 4,200 adverse effects, including 1,042 hospitalizations, nearly 600 instances of blood loss requiring transfusions, and other serious complications.<\/p>\n

Despite all of this, Danco is no longer mandated<\/a> to notify the FDA of complications, so no one may ever know just how many women have been injured by the abortion pill.<\/strong>\u00a0In addition, the abortion pill is responsible for the deaths of about four million<\/em> preborn babies.<\/p>\n

Despite multiple requests to the FDA from Live Action News, no updates on total abortion pill numbers and deaths have been published since 2018. What is obvious, however, is that a REMS is still necessary for the abortion pill. Women should not have their health or lives put on the line because the abortion industry wants to ensure they continue to turn a profit while the COVID-19 threat lingers — and into the foreseeable future.<\/p>\n

*THE FDA HAS RECEIVED REPORTS OF SERIOUS ADVERSE EVENTS IN PATIENTS WHO TOOK MIFEPRISTONE. AS OF JUNE 30, 2022, THERE WERE 28 REPORTS OF DEATHS IN PATIENTS ASSOCIATED WITH MIFEPRISTONE SINCE THE PRODUCT WAS APPROVED IN SEPTEMBER 2000, INCLUDING TWO CASES OF ECTOPIC PREGNANCY (A PREGNANCY LOCATED OUTSIDE THE WOMB, SUCH AS IN THE FALLOPIAN TUBES) RESULTING IN DEATH; AND SEVERAL FATAL CASES OF SEVERE SYSTEMIC INFECTION (ALSO CALLED SEPSIS). 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 JUNE 30, 2022, IS\u202fHERE<\/a>. THE FDA HAS REVIEWED THIS INFORMATION AND DID NOT IDENTIFY ANY NEW SAFETY SIGNALS. THE FDA INTENDS TO UPDATE THIS SUMMARY REPORT AS APPROPRIATE.<\/span><\/em><\/h6>\n

\u201cLike\u201d Live Action News on Facebook<\/a>\u00a0for more pro-life news and commentary!<\/strong><\/em><\/p>\n","protected":false},"excerpt":{"rendered":"

UPDATE, 1\/6\/23: On\u00a0January 3, 2023, the Biden FDA moderated the REMS safety requirements for the\u00a0abortion pill to allow the deadly drug to be\u00a0sold through retail pharmacies\u00a0with a prescription. As of\u00a0June 30, 2022, U.S. sales of the abortion pill have\u00a0now ended the lives of 5.6 million babies in the U.S. since its approval in 2000, according […]<\/p>\n","protected":false},"author":303,"featured_media":186664,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"om_disable_all_campaigns":false},"categories":[9953],"tags":[],"yoast_head":"\nThe abortion pill: So dangerous it needs a rare safety requirement<\/title>\n<meta name=\"description\" content=\"The abortion pill is so dangerous it requires a rare safety requirement to protect women. 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Now the abortion industry is trying to remove that protection.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/archive.liveaction.org\/news\/abortion-pill-dangerous-safety-requirement\/\" \/>\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=\"2020-06-06T19:30:13+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2024-07-26T00:04:09+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/archive.liveaction.org\/news\/wp-content\/uploads\/2018\/08\/abortion-pill-woman-stomach.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=\"Carole Novielli\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:creator\" content=\"@https:\/\/twitter.com\/CaroleNovielli\" \/>\n<meta name=\"twitter:site\" content=\"@liveaction\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Carole Novielli\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"11 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\/\/archive.liveaction.org\/news\/abortion-pill-dangerous-safety-requirement\/#article\",\"isPartOf\":{\"@id\":\"https:\/\/archive.liveaction.org\/news\/abortion-pill-dangerous-safety-requirement\/\"},\"author\":{\"name\":\"Carole Novielli\",\"@id\":\"https:\/\/archive.liveaction.org\/news\/#\/schema\/person\/81ff4ca810d98b0b5b376a640452d9e6\"},\"headline\":\"The abortion pill: So dangerous it needs a rare safety requirement\",\"datePublished\":\"2020-06-06T19:30:13+00:00\",\"dateModified\":\"2024-07-26T00:04:09+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\/\/archive.liveaction.org\/news\/abortion-pill-dangerous-safety-requirement\/\"},\"wordCount\":2011,\"publisher\":{\"@id\":\"https:\/\/archive.liveaction.org\/news\/#organization\"},\"articleSection\":[\"Abortion Pill\"],\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\/\/archive.liveaction.org\/news\/abortion-pill-dangerous-safety-requirement\/\",\"url\":\"https:\/\/archive.liveaction.org\/news\/abortion-pill-dangerous-safety-requirement\/\",\"name\":\"The abortion pill: So dangerous it needs a rare safety requirement\",\"isPartOf\":{\"@id\":\"https:\/\/archive.liveaction.org\/news\/#website\"},\"datePublished\":\"2020-06-06T19:30:13+00:00\",\"dateModified\":\"2024-07-26T00:04:09+00:00\",\"description\":\"The abortion pill is so dangerous it requires a rare safety requirement to protect women. 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