Archive for adverse effects

FDA: 24 women die from abortion pill, thousands of serious complications

Posted in AAPLOG, Abortion death, Abortion pill, Abortion Pill Connections, Abortion Pill Horrors, DANCO, Daniel Grossman, Generic Abortion Pill, Inc., Packard Foundation with tags , , , , , , , , , , , , , , , , , , , , , , , , on April 23, 2019 by saynsumthn

As more women die from abortion pill, the FDA approves a generic version

abortion pill, emergency contraception

 

The FDA has approved a generic version of the abortion pill Mifeprex, at a time when more deaths are being reported and the abortion industry is pushing for the dangerous abortion inducing chemicals to be dispensed online or by mail. According to a notice from the FDA, the generic version is approved for use as an abortifacient. This news comes just a day before the FDA updated its adverse effects reports through 2018, stating, “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…” The FDA’s 2017 report put the number of deaths at 22.

This means that in 2018 alone, two more women died from taking the abortion pill. And yet, now a generic version is going to be made available.

Abortion Pill Deaths December 2018

Dec 2018 abortion pill deaths FDA

To date, the report documents nearly 4,200 reported adverse effects, including hospitalization and other serious complications.

On April 11, 2019, the FDA approved GenBioPro, Inc.’s abbreviated new drug application for a generic Mifeprex, which, when used with Misoprostol is approved as an abortion pill regimen. The FDA states (emphasis added), “This approval reflects FDA’s determination that GenBioPro’s product, Mifepristone Tablets, 200 mg, is therapeutically equivalent to Mifeprex and can be safely substituted for Mifeprex. Like Mifeprex, the approved generic product is indicated for the medical termination of intrauterine pregnancy through 70 days gestation….”

READ: The secrecy surrounding the abortion pill’s maker and influential financial investors must end

Generic abortion pill by GenBioPro approved by FDA

The FDA also states clearly that although they modified the Mifeprex application to include “mifepristone products,” this change in no way removes the FDA’s REMS (Risk Evaluation and Mitigation Strategy), “a safety strategy to manage a known or potential serious risk associated with a medicine and to enable patients to have continued access to such medicines by managing their safe use.”

Of note, on April 11, 2019, FDA approved a supplemental application for Mifeprex, approving modifications to the existing approved REMS for Mifeprex to establish a single, shared system REMS for mifepristone products (including Mifeprex as well as the approved generic version of Mifeprex) for the medical termination of intrauterine pregnancy through 70 days gestation. In establishing the single, shared system REMS, no changes were made to the substantive elements of the REMS. This single, shared system REMS is known as the Mifepristone REMS Program.

Find approval information for this 2019 supplement here.

The approved generic version of Mifeprex generally has the same labeling as Mifeprex…Under the law, the approved generic version of Mifeprex is required to use a single, shared system REMS with the brand product, Mifeprex. This single, shared system REMS, known as the Mifepristone REMS Program, sets forth the distribution requirements that must be followed for both Mifeprex and the approved generic version of Mifeprex.

Requiring that the generic be subject to FDA’s REMS is good news for now, because, as Live Action News has previously reported, the abortion lobby is attempting to expand access to the abortion pills via mail order or pharmacy by pushing “self-managed abortion,” described by Guttmacher as ending a pregnancy “without direct supervision by a health care provider.” To accomplish this, REMS, must be eliminated.

READ: What you should know about the dangerous ‘self-managed’ abortion pill push

Dr. Donna Harrison, Executive Director American Association of Pro-Life Obstetricians and Gynecologists(AAPLOG), agreed, telling Live Action News (emphasis added):

Allowing a generic equivalent of Mifeprex basically means that the patent restrictions have run out. So, new drugs have a patent which is time limited… and in the case of Mifeprex, the patent was held by the Population Council. So, now that the patent has run out, generics are allowed. But this does not change the restrictions. REMS are still in place until FDA changes the restrictions. So, just to clarify, this does not mean that Mifeprex is OTC [over-the-counter]. It just changes how much quality control goes in to the pill manufacturing process and how much Danco can charge for the drug.

The move towards a generic drug is being hailed a victory by abortion advocates, specifically Dr. Daniel Grossman, who has deep tiesto the “self-managed” abortion pill push.

Image: FDA Approves generic abortion drug (Image Twitter Dr. Daniel Grossman)

FDA Approves generic abortion drug (Image Twitter Dr. Daniel Grossman)

Image: FDA Approves generic abortion drug NWHC (Image: Twitter)

FDA Approves generic abortion drug NWHC (Image: Twitter)

Under the Mifepristone REMS Program, the FDA states, “Mifeprex and the approved generic version of Mifeprex” may:

  • [O]nly be supplied directly to healthcare providers who are certified to prescribe the drug product and who meet certain qualifications.
  • [T]he products are only available to be dispensed in certain healthcare settings, specifically, clinics, medical offices and hospitals, by or under the supervision of a certified prescriber.
  • They are not available in retail pharmacies and are not legally available over the Internet.

The original drug (Mifeprex) was approved in 2000 after being brought to the U.S. by the eugenics-founded Population Council, and was seeded by the Packard Foundation among other pro-abortion philanthropy groups. They then set up a highly secretive company named Danco to manufacturer the drug.

The generic version is produced by GenBioPro, Inc., which also appears to have the financial support of abortion collaborators. In fact, Packard gave GenBioPro, Inc. $185,000 in 2016 and 100,000 in 2017. According to the Nevada Secretary of State, a 2007 filing for the company was permanently revoked. A new filing in 2011 is active and shows a registered agent of CSC Services of Nevada, Inc. and the only officer listed is E. Masingill.

The FDA warns consumers they should not buy Mifeprex or GenBioPro, Inc.’s approved generic version of Mifeprex, Mifepristone Tablets, 200 mg., over the Internet because they will bypass important safeguards designed to protect patient health.

    • This article is reprinted with permission. The original appeared here at Live Action News.

Dying for the abortion pill !

Posted in Abortion, Abortion complication, Abortion death, Abortion injury, Abortion pill, Morning After Pill, RU-486 with tags , , , , , , , , , , on July 18, 2011 by saynsumthn

This video is from 2005 – since then several more women have died….is abortion worth YOUR life?

Vodpod videos no longer available.

Abortion pill warning- too many deaths, posted with vodpod

The Truth About Chemical Abortion and Women’s Health: Updated FDA on RU486

by Jeanne Monahan
July 12, 2011

A summary of adverse event reports (AERS) recently released by the Food and Drug Administration (FDA) and obtained through Sen. Orrin Hatch’s office reveal that in the span of almost eleven years since the approval of the abortion drug, popularly known as RU-486, in the United States, at least 11 women have died as a result of complications related to taking the drug.[1] Internationally, the number of women who have died as a result of RU-486 is at least 17.[2]

That’s not all. The dangerous complications associated with this drug continue include hemorrhaging and infection. In the U.S., at least 612 women have been hospitalized after taking RU-486; and at least 339 women required blood transfusions as a result of serious blood loss after taking the abortion drug.

Clearly highlighting the need for more stringent medical oversight, the report also indicates that 58 women were prescribed RU-486 despite having ectopic pregnancies. Yet, “[a]dministration of mifepristone and misoprostol is contraindicated in patients with confirmed or suspected ectopic pregnancy.”[3] To state it more clearly, a woman who has an ectopic pregnancy and takes the RU486 regimen places her life in danger.

It is not only women in the U.S. who are suffering as a result of chemical abortion, it is a worldwide trend. A recent Australian health department audit of nearly 10,000 abortions performed in 2009 and 2010 compared the safety of RU-486 with surgical abortion, with the outcome being in the words of one major media outlet “The Abortion Pill ‘Less Safe than Surgery’”. The Australian report showed that 1 in 18 patients who used RU-486 had to be re-admitted to hospitals (a total of 5.7% of women vs. only .4% of surgical abortions.) The same study revealed that as many as 33% of women who had second trimester RU-486 abortions required some form of surgical intervention.[4]

Marketing the abortion drug as simple and painless, such as taking an aspirin, is dangerously misleading to women. RU-486 is in a class of drugs categorized as selective progesterone receptor modulators, which, in addition to blocking progesterone necessary for the developing baby, also suppresses a woman’s immune system. Additionally, it is sometimes the case that the remains of the pregnancy are not entirely expelled from a woman’s uterus, causing infection and other problems.

Despite the seriousness and intensity of adverse effects related to RU-486, use of this form of abortion is on the rise, and frequently the regimen is dispensed with less medical oversight than surgical abortion. Even more troubling, nationally and internationally, “telemed” dissemination of RU-486 is increasing.[5] Telemed abortions involved doctors proscribing RU-486 through skype or over the internet rather than during a patient visit.

The bottom line is that abortion drugs are not about improving women’s health but are more accurately about advancing a radical pro-abortion agenda regardless of the impact on women’s health, even when it proves deadly.

[1] Food and Drug Administration, “Mifepristone U.S. Postmarketing Adverse Events Summary through 04/30/2011” (http://downloads.frc.org/EF/EF11G29.pdf).

[2] Ibid.

[3] Jamie Walker, “Abortion pill ‘less safe than surgery’,” The Australian (May 7, 2011) (http://www.theaustralian.com.au/national-affairs/abortion-pill-less-safe-than-surgery/story-fn59niix-1226051434394).

[4] EA Mulligan, “Mifepristone in South Australia” Australian Family Physician Vol. 40, No. 5, May 2011 (http://www.frcblog.com/wp-content/uploads/2011/05/Australian-AERs_RU486_201105mulligan.pdf).

[5] Michel Martin (host), “Growing Controversy Surrounds ‘Telemed’ Abortions,” National Public Radio (January 24, 2011) (http://www.npr.org/2011/01/24/133182875/Growing-Controversy-Surrounds-Telemed-Abortions).