How does this FDA decision affect your center, your clients and your community?
Considerable changes were made to the Risk Evaluation and Mitigation Strategy (REMS) safety program. These changes affect how it can be prescribed and dispensed. This decision by the FDA will affect thousands of women in the coming year.
There are over 20,000 prescription drugs approved by the FDA, there are just 74 medications deemed so dangerous to warrant a REMS restriction and one of these was mifepristone.
A Risk Evaluation and Mitigation Strategy (REMS) is a drug safety program that the U.S. Food and Drug Administration (FDA) can require for certain medications with serious safety concerns to help ensure the benefits of the medication outweigh its risks.
This was one last safety barrier in place for chemical abortion of a process that’s been shown to be four times more dangerous than surgical abortion.
The REMS for mifepristone was intended to minimize the significant risk of hemorrhage, retained fetal tissue, and infection – symptoms that can quickly become life-threatening for women. This was not restrictive – it was protective of the thousands of women who take this drug every year in the US.
We really do not have a true picture of the dangers of mifepristone because the FDA made the decision in 2016 to stop collecting data on nonfatal adverse events related of mifepristone - instead they have only been collecting data on maternal fatalities related to the drug. Unless women actually died, they did not make note of the complications or injuries to women caused by mifepristone for more than five years. With only voluntary reporting, no one in America is systematically collecting data on the women hurt or killed by mifepristone complications.
However, recent analysis of the Adverse Events submitted to the FDA with the REMS in place shows over 3000 women suffering with complications, of which 24 of those women died, and another 500 would have died if they had not reached emergency medical care in time. And we know that up to 7% of women will need surgical intervention after a chemical abortion.
Mifepristone causes pain and bleeding that can become perilous, but the FDA also warns women to expect nausea, weakness, fever/chills, vomiting, headache, diarrhea, and dizziness in the first day or two. Chemical abortion is quite a miserable experience for nearly all women who take these drugs, dangerous for the thousands suffering complications and can even be deadly for the most unfortunate.
The FDA said it made changes "to minimize the burden on the healthcare delivery system" and "to ensure that the benefits of the drug outweigh the risks." Sadly, the FDA has chosen to ignore the thousands of women in need of emergency care who were injured by chemical abortion and has caved to the pressures of ACOG, World Health Organization, the American Medical Association and Big Abortion.
Although the FDA continues to allow in-person dispensing at a clinic or other medical setting, the FDA removed the requirement that it must be dispensed in person. This means that abortion pills can now be sent in the mail across state lines without seeing a doctor. Regrettably, telemedicine has emerged as a viable option to expand the availability of abortion. By lifting the REMS, the FDA has allowed providers in states without telehealth restrictions to dispense mifepristone without a clinic visit. There is much risk in not providing assessment for ectopic pregnancy, accurate determination of gestational age, testing and treatment for Rh- incompatibility, fully informed consent, and assessment for coercion prior to prescribing mifepristone.
Mifepristone must be prescribed by or under the supervision of a certified healthcare provider who meets certain qualifications. The prescriber must sign a Prescriber Agreement Form with the manufacturer and patients must still sign a "Patient Agreement Form.” When signing this form, women agree they were counseled regarding the dangers of bleeding, infection and ectopic pregnancy; the failure rate of chemical abortion (estimated by the manufacturer to be 3-7%); and what to do in the event of emergency symptoms. They also must agree to take the second drug, misoprostol, 24-48 hours later, which inappropriately seems to remove their rights to withdrawal their informed consent if they wish to continue their pregnancies. They are also provided with a letter to take to the emergency department if symptoms require urgent medical care.
Previously, mifepristone was not available by prescription at commercial pharmacies. Women couldn’t just pick it up at Walgreens or CVS; it was most frequently prescribed and dispensed at an abortion facility. The FDA is now allowing prescriptions at certified pharmacies, helping to facilitate e-prescriptions for mifepristone. This certification is between the pharmacy and the manufacturer of the abortion drug and is not regulated by the FDA.
Informed consent is the idea that patients have the right to know as much information as possible about the risks and benefits of a medical procedure and use that knowledge to decide whether they want to receive the procedure. There are many ways your center can assist women to be fully informed about their pregnancy decisions:
If your client has started a chemical abortion and has regret, she can learn more about reversing the effects of chemical abortion and possibly continuing her pregnancy by contacting the Abortion Pill Rescue® Network hotline 877.558.0333 or at the APR website to begin a live chat. We have a team of nurses waiting to answer questions, explain reversal, and connect her with an APRN Provider in her area.
Women deserve to know the truth; they don’t give up that right when they seek an abortion. Help is available for women who have taken the first abortion pill and experience regret. APRN offers the chance to reverse the effects of the chemical abortion pill and potentially continue their pregnancies. Statistics show that more than 2,500 babies have been saved through the APRN.
By now, you have probably seen that Google has banned any and all advertising efforts promoting Abortion Pill Reversal. This life-saving protocol has been pulled down under a new Google policy that bans "unreliable claims."
Unfortunately, Google is wrong. Time and again, we have seen the power of Abortion Pill Reversal in the mothers' gratitude and the babies' smiles. Statistics show more than 2,500 lives have been saved so far thanks to Abortion Pill Reversal and you, those on the frontlines meeting with women and offering true choice.
Thankfully, in spite of the ads being pulled, women are still finding the APRN for help. Through sidewalk advocates, pregnancy centers, word of mouth, and organic search results, we are still seeing reversal starts!
Women who find our Network do so out of an inherent motherly instinct to save her baby's life in a way that, sadly, Google would rather they never know about. These women find our Abortion Pill Rescue Network primarily through Google searches. More than 90% of our contacts come from online referrals - both paid and organic.
Big Tech's censorship of Abortion Pill Reversal denies women the right to try to save their pregnancies. It makes completing the chemical abortion the only option for them.
We know the truth. Reversal works for 2 out of 3 women. While Google claims Abortion Pill Reversal is an "unreliable claim," we get to see in the flutter of the heartbeat on our ultrasound machines; the tears of happiness on the mom's face; and the relief in her voice when we get to tell her that she was able to save her baby's life.
In fact, just this past Friday, the Charlotte Lozier Institute published a report showing the efficacy of Abortion Pill Reversal.
Heartbeat International and our pro-life friends are working hard to fight this attack by Big Tech and will continue to do so. Every woman deserves to know the whole truth about abortion; that includes the facts about her unborn child, and the choices she can make every step of the way.
If your organization is experiencing issues having your digital ads approved, read What You Can Do Right Now About "Unreliable Claims"
Keep fighting the good fight! We're here for you.
Brent Boles, M.D.APRN Medical Director
This month we are highlighting Teresa Tholany, one of our Healthcare Team Managers. Teresa assists our affiliates with their medical questions and oversees the Abortion Pill Reversal Hotline. Before Teresa joined our Medical Impact team she was working in a Pregnancy Help Clinic for nearly five years and also in an administrative position in a hospital. She has been such a blessing to our team and for those of you who have already talked with her, we know you love her too!
Where did you grow up and go to school? I grew up near Buffalo, NY a few miles away from Lake Erie - a prime location for lake effect snow! I was homeschooled K-12th grade so even when we did get lake effect snow and the school district had a snow day, we didn't get a snow day because our books and teacher were at home with us!
Tell us about your recent wedding. My husband and I got married this past July and the wedding day truly was a dream and went so smoothly! We got married in Hamburg, NY and Joe's family traveled across the state from Congers, NY to be present for the wedding festivities! Joe's parents are from Kerala, India so we included some traditions that are important to them in our wedding.
Tell us about your husband. Joe and I met at work at the hospital. I was a floor nurse and he was a resident. I was adamant that I would never date a doctor and he always said he would never date a nurse - I guess we're proof it just takes the right person to change your mind and take a chance on! We actually worked together for two years before we started talking and dating. Joe is now in his second and final year of fellowship as an Infectious Disease Doctor and looks forward to working as an attending next year.
Tell us about your experience assisting with the Love Approach ultrasound clinical. Training nurses has been one of the best work experiences I have ever had. Everyone loves to share with others something that they are passionate about - and limited ultrasounds happen to be something I am passionate about! Being able to encourage, empower, and equip other nurses to perform limited OB ultrasounds using the LOVE Approach method was not only a great opportunity to share something I am passionate about with others, but it also gave me the opportunity to be inspired by the eagerness the nurses had to go back to their centers and introduce moms and dads to their babies via limited ultrasound!
What was your favorite part of helping clients in a center? My favorite part of helping clients in the center I worked at was showing the moms, dads, and families their little baby on the ultrasound screen.
Tell us about helping clients on APR hotline and now overseeing the hotline. Working with clients on the hotline gave me an even deeper respect and admiration for women who seek reversal of a chemical abortion. Seeing their momma instincts kick in and their bravery and determination to do everything in their power to help their baby is truly inspiring. Now as a Healthcare Team Manager overseeing the hotline, it is amazing to see the bigger picture of how many women our hotline nurses are impacting each and every day. It is humbling to have the privilege of working with and praying for the nurses who are assisting women who are in such difficult positions.
Tell us about working with the Medical Impact team. The Medical Impact Team is the best group of coworkers anyone could ask for! The leadership, support, and camaraderie on the team is a blessing! It is a gift to work in an environment that aligns with your beliefs and where everyone is striving to advance the same cause.
Tell us about how you help affiliates now with their medical services in a center. I enjoy serving our affiliates by answering their questions about ultrasound training, STI testing, offering abortion pill reversal in their center, and anything and everything related to the medical services centers offer. It is always wonderful to connect with our affiliates one-on-one and support them in their endeavors.
What do you enjoy most about your work? Mother Teresa said, "we can do no great things, only small things with great love." I enjoy all of the small opportunities that my job offers me - assisting an affiliate with a question, helping a nurse on the hotline find a provider for a woman seeking reversal - because these small situations offer opportunities to not just serve others but to serve others with great love which is what we are all called to do in life but especially in pregnancy help organizations.
What are your favorite things to do outside of work? You can always find me in the kitchen cooking or baking or in the living room working out when I'm not working!
What else would you like to share? The "So Delicious" dairy-free Dipped Coconut Almond Coconut Milk Ice Cream Bars are the most delicious frozen treat there is!
by Brooke Myrick BSN, RN, LAS
“With zero hesitation I called the number and was answered by a very kind, helpful and empathetic representative who listened to my concern. She was so caring and really helped me feel a great sense of hope. She handled my call with genuine care, but urgency, as she explained that the agency would locate an APR provider in my area who would be able to administer the progesterone and provide me with special and closely monitored maternity care.
"I felt a calm come over me that I was in the right vein where God wanted me to be and to just trust that He is now in control of the situation! God gave me the name Serenity Grace and I believe she brings just that to my life in a very deep and meaningful way! With His help, guidance, inner healing, love, and goodness I made it to FULL TERM. At 39 weeks on January 27, 2021, my miracle baby arrived!” - Kayla, APR Client
These are the stories that bring APR to life! Statistics now show that more than 2,500 lives have been saved (and counting) as women successfully stop their chemical abortions and save their children through the Abortion Pill Rescue Network.
A woman who would like to learn more about reversing the effects of chemical abortion and possibly continuing her pregnancy should call the Abortion Pill Rescue hotline 877.558.0333 or go to the APR website to begin a live chat. Heartbeat International has medical professionals waiting to answer her questions, explain reversal, and connect her with an APR Network Provider in her area 24 hours a day, seven days a week.
While Google may have taken down the ability to advertise for APR, AbortionPillReversal.com website, phone, and chat are still available and can be found organically through a search. We continue to be available for women. We need your help now more than ever to promote this life-saving protocol.
Pro-Life Network that Manages Abortion Pill Rescue Network Calls Out Report Google Used to Ban Life-Saving Ads
Columbus, OH – Today, Heartbeat International, the world’s largest pregnancy help network, which manages the Abortion Pill Rescue Network, sent a letter to the Center for Countering Digital Hate (CCDH) demanding that they remove factually false information from the “Endangering Women for Profit” report.
On Tuesday, Google removed Heartbeat International’s ads promoting the Abortion Pill Reversal hotline following the inaccurate claims within the CCDH report. Other news outlets then amplified this false data in their own reporting.
The letter from Heartbeat calls for the full and immediate removal of incorrect data from the report and requests a correction be published, noting the inaccuracies.
“The CCDH’s choice to base this report on inaccurate information and a single failed study demonstrates their interest is promoting Big Abortion and not empowering women with real choices,” said Jor-El Godsey, President of Heartbeat International. “By removing Abortion Pill Reversal ads from Google, they silence the only viable option for women who are looking to reverse the effects of the abortion pill, effectively forcing women to complete an abortion they no longer want.”
Statistics show that Abortion Pill Reversal has saved over 2,500 babies and empowered women by putting choice back into their hands. These are the stories that the ads targeted by Google and CCDH tell. The Center for Countering Digital Hate would rather pretend these women and children do not exist than allow a true choice for women.
View the letter here.
For more information on Heartbeat International go to www.HeartbeatInternational.org.
About Abortion Pill Rescue Network: Abortion pill reversal is a cutting-edge application of a time-tested, FDA-approved treatment used for decades to prevent miscarriage and preterm birth. It involves emergency, ongoing doses of progesterone to counteract the effects of the first abortion pill. From the moment a woman takes the abortion pill, she has about 72 hours to change her mind and save her baby. The Abortion Pill Rescue Network answers more than 300 mission-critical calls a month from women who regret their abortion decision. Statistics show that more than 2,500 lives have been saved (and counting) through the abortion pill reversal protocol.
If you or someone you know took the abortion pill and regret it, there may still be time. The Abortion Pill Reversal hotline provides free and confidential care 24/7. Call 877.558.0333 or go to www.AbortionPillReversal.com now. There may still be time to save your pregnancy.
About Heartbeat International: Heartbeat International is the largest network of pro-life pregnancy help in the world, with nearly 3,000 affiliated locations in more than 70 countries. Heartbeat's mission is to Reach and Rescue as many lives as possible, around the world, through an effective network of life-affirming pregnancy help, to Renew communities for LIFE in order to achieve their vision of making abortion unwanted today and unthinkable for future generations.
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