More than 40 advocacy and medical organizations submitted a petitionThe Food and Drug Administration (FDA), asking that miscarriage management be added as an use case for mifepristone. This drug is commonly used in medical abortions and the restrictions surrounding who can prescribe it.
Groups that include the American College of Obstetricians and Gynecologists (ACOG), SisterReach, Physicians for Reproductive HealthThe Expanding Medication Abortion Access (EMAA) ProjectThey were behind the petition. The Tuesday changes they requested would make the drug more accessible to miscarriage sufferers. After the end of the war, some doctors and pharmacies were less willing to distribute it. Roe v. Wade.
Combining misoprostol and mefepristone is the best way to take Mifepristone. most effective regimen for the medical management of miscarriageand medication abortions. Patient access to this drug is currently limited because of both the absence of FDA approval of mifepristone explicitly for miscarriage management and because the drug’s Risk Evaluation and Mitigation Strategy (REMS), the set of restrictions around the drug set by the FDA, limits clinicians’ ability to prescribe mifepristone.
One in 6 known pregnancies globally end in miscarriageIt is a common problem in unrecognized pregnancies, which accounts for about 25% of all cases. The FDA petition states that miscarriage is also more common among pregnant people who are Black, low incomeExposure to environmental pollutants.
Mifepristone was approved by the FDA in 2000. It can now be administered to patients in person under the supervision of a certified physician. Such regulations are in place because of mifepristone’s FDA labeling as a drug indicated for use in medication abortion. Because of this, many medical and advocacy groups say, there is a stigma attached to mifepristone — one that makes the drug harder to access for patients seeking abortion care and miscarriage management care alike.
The American Civil Liberties Union filed a lawsuit against the FDA during the pandemic. They were representing a group medical providers and asked that the REMS be removed. This was because the FDA’s in-person dispensing requirement made it impossible to access mifepristone during lockdown. They were successful and patients were temporarily permitted to receive mifepristone via mail or from specially accredited pharmacies. An FDA policy change in December 2021made the temporary pandemic modifications permanent to the REMS
The FDA should add miscarriage management to the mifepristone list, according to groups petitioning it. This is because it is the most effective method for medical management of miscarriage. It has been proven safe and effective in this case until the first trimester (when 80 percent of all miscarriages occur).
“The evidence is clear that mifepristone improves the outcomes of our patients who are experiencing pregnancy loss, minimizing the need for additional interventions during an already traumatic experience at a time when compassionate care is critical for their physical and emotional recovery,” said Dr. Maureen G. Phipps, chief executive officer of ACOG.
Following the reversal of Roe, many states have passed new laws severely restricting, and sometimes fully banning, medication abortion, which uses the same medications — mifepristone and misoprostol — used in medical miscarriage management. Some states have made it illegal to mail Mifepristone. Others have limited the time that medication abortion can be used. Some states have even moved to ban abortion pills entirely.
Advocates claim that miscarriage sufferers who use mifepristone are also at greater risk of criminalization. Because low-income and people of color are also at risk, most likely to be punished or face jail timeAdvocates for the label modification say that this change could allow those who need abortions to access mifepristone in miscarriage management and not be criminalized for seeking them.
Kirsten Moore, the director for the EMAA Project, said The 19th that the current climate surrounding mifepristone access is one where “confusion plus criminalization equals chaos — which leads to cruelty.”
“The fact that some states are trying to criminalize an FDA-approved drug is something we cannot pretend isn’t happening and these attempts are shutting down the willingness of health care providers to offer this care, whether in the context of abortion or miscarriage, which is amping up the pressure that patients might face as they do their own risk calculus in seeking this care,” Moore said. “As an advocacy community, we needed to make mifepristone’s potential clear.”
Mifepristone has been used by health care professionals off-label to manage miscarriage for years. However, because of the REMS not all providers can write prescriptions for it. Moore stated that providers may prescribe misoprostol-only miscarriage management if they are not able to prescribe it easily. Patients must take a large amount of the medication for it to work, and suffer severe cramping.
“The mifepristone-misoprostol regimen is simply more effective. … We know it’s more effective, we know it’s safe, and anyone going through this experience should be offered this care,” Moore said.
In the event of missed or incomplete miscarriage (when the body has not completely expelled the pregnancy tissue), medical intervention is required. Miscarriage without medical intervention can lead to hemorhage, sepsis, or even death. StudiesThey have proven that medically managed miscarriages conclude faster than miscarriages that happen without any kind of medical or surgical threatmet — often within a few hours if not more than a few days, compared with up to eight weeks. People who begin medication management for their miscarriage are less likely need to have a later surgery to empty the uterus.
Patients may have difficulties accessing the care they need because of the current labeling.
Hannah, who requested that her name not be used for privacy reasons, was thrilled to find out that she was pregnant for the very first time in January. The North Carolina resident and her partner began planning the nursery immediately and exchanged ideas about parenting philosophies in a Google spreadsheet. Hannah was concerned that Hannah might miscarry just weeks after her first positive at-home pregnancy test. She went to the emergency department.
Many medical tests later, the viability of Hannah’s pregnancy was determined inconclusive. She was told to go home and to “wait it out” and given the number for a clinic affiliated with the hospital to continue to evaluate the status of her pregnancy.
Hannah began to experience bleeding at home just shy of 11 weeks. She was then referred to the emergency department. Her miscarriage had not resolved by itself. Hannah asked for medication management in order to end her miscarriage. The ER doctor shocked her when she told her that even though she wished she could, they couldn’t. She was not legally able to do so because she wasn’t an authorized provider of mifepristone as defined by the REMS.
The doctor, Hannah recalls, said “her hands were tied,” and referred Hannah to another clinic — a specialty family planning provider — who was legally able to prescribe the medication Hannah would need to complete her miscarriage. Hannah called the clinic to schedule an appointment. Hannah had to wait for four days before she could be seen. Finally, Hannah was able to be seen by a provider there who confirmed that Hannah’s miscarriage was not complete, prescribing her mifepristone.
“It was really deeply disappointing to have to continue to have to deal with the miscarriage when there could have a way to treat it given the harsh physical and emotional symptoms I was having,” Hannah said. “It could have been resolved four days earlier. That might not sound like a lot to someone not having a miscarriage, but to someone having one, that’s awful.”
“I was really mourning this child we thought we were going to have and was no longer going to be entering our lives,” she continued. “I had to prolong the physical process of dealing with it all because, to my view, of a political agenda.”