Four national medical associations and four doctors filed a lawsuit in November against the Food and Drug Administration (FDA), claiming that the FDA illegally approved the abortion pill in 2000, putting the well-being of women and girls at risk. One board-certified OB/GYN is now sharing that she and her colleagues are frequently seeing complications from the abortion pill.
Behind the lawsuit are the groups the Alliance for Hippocratic Medicine, the American Association of Pro-Life Obstetricians and Gynecologists (AAPLOG), the Christian Medical & Dental Associations, and the American College of Pediatricians. AAPLOG board member and CEO-elect Dr. Christina Francis told Newsmax that she has seen firsthand the harm that is being done to women and girls by the abortion pill.
“Women and girls are being endangered and injured every day in our country through these dangerous chemical abortion drugs,” she said. “I am a board-certified OB/GYN and I practice in an in-patient setting and I, personally, along with many of my colleagues, have seen women and girls come in through our emergency rooms with severe complications from these drugs. Complications that should be being addressed by the FDA. Complications like heavy bleeding and hemorrhage and the need for emergency surgery, the need for admission to the hospital for blood transfusions and infections, and even one of our members took care of a woman who likely will not be able to have children in the future because of major complications that required two major surgeries to correct these complications due to these chemical abortion drugs.”
[The FDA’s] initial approval [of the abortion pill] in 2000, they did do some testing on adults but they did not test in the pediatric population. And yet, ever since its approval, it has been allowed to be used in the pediatric population, and this is a population of girls who would be very susceptible to manipulation of hormones which is exactly what the first drug, mifepristone, does. It binds to receptors on cells and blocks the action of progesterone, which is a key hormone not only in normal development for girls but also a key hormone in early pregnancy, which is how it works to end the life of preborn children.
According to the Alliance Defending Freedom (ADF), which filed the lawsuit on behalf of the pro-life groups, “The U.S. Food and Drug Administration chose politics over science when it pushed for the legalization of the chemical abortion drugs mifepristone and misoprostol in 2000. The only way the FDA was able to approve the drugs was by characterizing pregnancy as an ‘illness’ and arguing that these drugs provide a ‘meaningful therapeutic benefit.'”
The FDA does not require mifepristone’s adverse events to be reported — unless the woman dies. The deaths of 28 women have been connected to the use of the abortion pill in the U.S.*
ADF states that the FDA never actually studied the safety of the drugs under the labeled conditions of use and it ignored the potential dangers of the abortion drugs on the developing bodies of teenage girls. The FDA is also alleged to have ignored evidence that showed the abortion pill could cause more complications than surgical abortions. In fact, research has shown that the abortion pill is actually four times more dangerous for women and girls than a first-trimester surgical abortion.
The results of the pro-abortion Gynuity-sponsored study published in 2021 in the journal Contraception revealed that six percent (6%) of 1,157 women who took the abortion pill visited the emergency room or an urgent care center for abortion pill-related complications. Ten of those were serious effects, with five women requiring blood transfusions.
This data mirrors that of abortion complications in the United Kingdom, where it was found that nearly six percent (6%) of women who took the abortion pill in the UK between June 1, 2019, and May 31, 2021, were treated for complications. A 2020 report from the abortion group Marie Stopes Australia also revealed an overall complication rate of 6.37% for women who took the abortion pill that year.
The lawsuit also contends that the FDA failed women again when it rolled back safety restrictions, removing the regulation that the first drug (mifepristone) of the abortion pill regimen is taken in the presence of a doctor who has been certified to dispense it. Then the FDA allowed the abortion pill to be distributed through the mail despite federal restrictions stating otherwise, and now the FDA is allowing retail pharmacies to dispense the abortion pill.
ADF Senior Counsel Erik Baptist told Newsmax that the lawsuit aims to right the wrong done by the FDA in approving the abortion pill and then removing safety protocols surrounding it.
“We have two goals for this lawsuit,” he said. “The first is for the court to compel the FDA to do what it was supposed to do 22 years ago and take these dangerous drugs off the marketplace. But if not, and at minimum, restore and strengthen the previous safeguards that were afforded women when it was initially approved. The FDA has systematically, over time, taken away basic precautionary protections for women and girls who take these drugs and it has created now a very dangerous situation for them.”
*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 HERE. THE FDA HAS REVIEWED THIS INFORMATION AND DID NOT IDENTIFY ANY NEW SAFETY SIGNALS. THE FDA INTENDS TO UPDATE THIS SUMMARY REPORT AS APPROPRIATE.
Editor’s Note, 2/27/23: This post has been updated since original publication.
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