Mifepristone access is coming before the US Supreme Court. How safe is this abortion pill?

OF ITS BIGGEST CASES OF THE TIRM ON TUESDAY. IT CENTERS AROUND MIFEPRISTONE, ONE OF THE MOST COMMONLY USED ABORTION PILLS THE FOOD AND DRUG ADMINISTRATION APPROVED MIFEPRISTONE IN 2000 AND OVER THE YEARS, THE FDA HAS TAKEN STEPS TO EXPAND ACCESS, ALLOWING DOCTORS TO PRESCRIBE IT VIA TELEHEALTH APPOINTMENTS. FOR EXAMPLE, LAST YEAR, THOUGH, A US DISTRICT JUDGE IN TEXAS TOOK ISSUE WITH THE FDA’S ORIGINAL APPROVAL. HE ALSO CHALLENGED THE LATER MOVES THAT EXPANDED ACCESS TO THE DRUG. A COURT DEEMED IT WAS TOO LATE TO OVER TURN THE FDA’S OVERALL APPROVAL OF MIFEPRISTONE. BUT THE CASE AGAINST THE EXPANDED ACCESS IS MOVING FORWARD TO THE NATION’S HIGH COURT. AMY HOWE COVERS THE SUPREME COURT, JOINS ME IN STUDIO. USUALLY WE DO THIS REMOTELY, BUT IT’S SO NICE TO HAVE YOU IN OUR HOME. THANKS FOR JOINING ME. THANKS FOR HAVING ME. I FEEL LIKE EVERY TIME I TALK TO YOU, IT’S LIKE, WHAT IS THIS REALLY ABOUT? WHAT ARE THEY ACTUALLY ARGUING OVER? SO THIS IS A VERY TECHNICAL CASE ABOUT THE FDA. WHEN IT DECIDED TO EXPAND ACCESS TO MIFEPRISTONE, WHAT IT DID OR DIDN’T LOOK AT IN TERMS OF EVIDENCE ABOUT THE SAFETY OF THESE CHANGES IS CHANGES LIKE MAKING MIFEPRISTONE AVAILABLE THROUGH THE 10TH WEEK OF PREGNANCY INSTEAD OF THE SEVENTH, ALLOWING IT TO BE PRESCRIBED BY TELEHEALTH APPOINTMENTS AND THEN ALLOWING HEALTH CARE PROVIDERS WHO AREN’T PHYSICIANS TO PRESCRIBE THE DRUG. AND SO THE THE FIFTH CIRCUIT SAID THAT WHEN IT MADE THESE CHANGES IN 2016, THE FDA DIDN’T CITE A STUDY T THAT LOOKED AT THE CUMULATIVE EFFECT OF ALL OF THESE CHANGES AND WHETHER OR NOT IT WOULD STILL BE SAFE TO TO TAKE MIFEPRISTONE. IN LIGHT OF ALL OF THESE CHANGES, THE BIDEN ADMINISTRATION AND DANCO, WHICH IS THE MANUFACTURER OF MIFEPRISTONE, SAID, YOU KNOW, FIRST OF ALL, THAT WE DID CITE SUCH A STUDY, BUT MORE BROADLY THAT THE FDA REASONABLY CONCLUDED THAT THERE WERE NO SAFETY PROBLEMS BASED ON ALL OF THE EVIDENCE THAT IT HAD BEFORE THIS IS NOT A CONSTITUTIONAL QUESTION. THIS IS A VERY TECHNICAL QUESTION ABOUT THE FDA’S DECISION THAT IT WAS SAFE TO MAKE THESE CHANGES TO MIF TO MIFEPRISTONE USE, AND IS THERE AN ULTIMATE GOAL THIS WAS A CASE THAT CAME AFTER DOBBS AND SO IF YOU REMEMBER IN DOBBS, THE SUPREME COURT SAID THERE’S NOT A CONSTITUTIONAL RIGHT TO AN ABORTION. AND SO YOU KNOW, I THINK 21 STATES AND NOW HAVE LAWS IN PLACE THAT EITHER BAN OR, YOU KNOW, SIGNIFICANTLY RESTRICT ACCESS TO ABORTION. SO THAT MEANS THERE’S A LOT OF STATES WHERE ABORTION IS STILL LEGAL, BUT MEDICATION ABORTION IS USING MIFEPRISTONE ACCOUNT FOR MORE THAN HALF OF ALL ABORTIONS IN THE UNITED STATES. AND SO THIS WOULD MAKE IT MORE DIFFICULT TO USE MIFEPRISTONE IN THE STATES WHERE ABORTION IS STILL LEGAL. SO ULTIMATELY, IT’S AN OBSTACLE TO WOMEN WHO ARE TRYING TO GET AN ABORTION, EVEN IN STATES WHERE THEY’VE SAID, HEY, WE’RE SAFEGUARDING YOUR RIGHT TO AN ABORTION. THAT’S RIGHT. I KNOW ANOTHER ONE OF THE FRIEND OF THE COURT BRIEF SAID, EVEN IN THE STATES THAT THAT PROTECT THE RIGHT TO AN ABORTION, THERE ARE AREAS WHERE IT’S DIFFICULT. YOU MIGHT HAVE TO TRAVEL, FOR EXAMPLE, TO OBTAIN A SURGICAL ABORTION. AND SO WOMEN RELY ON THE AVAILABILITY OF MEDICATION ABORTIONS TO OBTAIN ABORTION CARE. AND THIS WOULD MAKE THAT HARDER. AND THEN DO YOU THINK THERE’S AN IMPACT FOR THE FDA AS A WHOLE, EVEN OUTSIDE OF THE ABORTION ISSUE? SO THERE POTENTIALLY IS AN IMPACT FOR THE FDA AS A WHOLE. AND DANCO, WHICH IS THE MANUFACTURER OF MIFEPRISTONE, SAYS, LOOK, DRUG MANUFACTURERS, OTHERS HAVE RELIED ON THE FACT THAT WHEN THE FDA APPROVES A DRUG, THEN COURTS AREN’T GOING TO COME ALONG AND SORT OF WILLY NILLY OVER TURN THAT APPROVAL. AND THIS WOULD OVERTURN ON THAT EXPECTATION. THEY SAY IT WOULD BE VERY DESTABILIZING FOR THE DRUG INDUSTRY. THERE’S ALSO A FRIEND OF THE COURT BRIEF FROM PATIENT ADVOCACY GROUPS LIKE THE AMERICAN CANCER SOCIETY THAT SAY THAT THIS CASE, IF THE SUPREME COURT WERE TO UPHOLD THE LOWER COURT’S DECISION, WOULD BE A ROAD MAP TO SORT OF LITIGATE THESE FUTURE CHALLENGES. AND IT COULD BE THINGS LIKE THE FDA DECIDES TO TAKE A DRUG THAT HAD BEEN AVAILABLE ONLY BY PRESCRIPTION AND MAKE IT AN OVER-THE-COUNTER DRUG. THEN SOMEONE COULD GO TO COURT AND TRY TO CHALLENGE THAT. AND AND THEY COULD FOLLOW ESSENTIALLY THIS ROAD MAP. AMY HOWE, ALWAYS NICE TO HAVE YOU. AN

The U.S. Supreme Court will take up a case Tuesday that could impact how women get access to mifepristone, one of the two pills used in the most common type of abortion in the nation.The central dispute in the case is whether the Food and Drug Administration overlooked serious safety problems when it made mifepristone easier to obtain, including through mail-order pharmacies.Legal briefs filed with the court describe the pill's safety in vastly different terms: Medical professionals call it “among the safest medications�� ever approved by the FDA, while the Christian conservative group suing the agency attributes “tens of thousands�� of “emergency complications�� to the drug.Earlier this year, a medical journal retracted two studies that claimed to show the harms of mifepristone. The studies were cited in the pivotal Texas court ruling that brought the matter before the Supreme Court. The publisher cited conflicts of interest by the authors and flaws in their research, although the studies' lead author called the retractions a baseless attack.Here’s what to know about the safety of mifepristone, which is typically used with misoprostol in a medication abortion.What safety limits has the FDA imposed since 2000?The FDA approved mifepristone in 2000 as a safe and effective way to end early pregnancies.There are rare occasions when mifepristone can cause dangerous, excessive bleeding that requires emergency care. Because of that, the FDA imposed strict safety limits on who could prescribe and distribute it �� only specially certified physicians and only as part of three mandatory in-person appointments with the patient getting the drug.The doctors also had to be capable of performing emergency surgery to stop excess bleeding and an abortion procedure if the drug didn't end the pregnancy.Video below: Get the Facts: 1873 Comstock Act Used in Abortion Pill DecisionOver the years, the FDA reaffirmed mifepristone's safety and repeatedly eased restrictions, culminating in a 2021 decision doing away with any in-person requirements and allowing the pill to be sent through the mail.How often are there serious problems?Abortion opponents say the more lax restrictions resulted in many more “emergency complications.�� But that argument lumps together women experiencing a range of issues with mifepristone �� from the drug not working to people who may simply have questions or concerns but don’t require medical care.OB-GYNs say a tiny fraction of patients suffer “major�� or “serious�� adverse events after taking mifepristone.A legal brief by a group of medical organizations including the American College of Obstetricians and Gynecologists says: “When used in medication abortion, major adverse events �� significant infection, excessive blood loss, or hospitalization �� occur in less than 0.32% of patients, according to a highly regarded study with more than 50,000 patients."The definition that scientists generally use for serious adverse events includes blood transfusions, major surgery, hospital admissions and death, said Ushma Upadhyay, one of the authors of that 2015 study. She added: “The hospital admission is a catch-all for the very serious but more rare events such as major infection.”The prescribing information included in the packaging for mifepristone tablets lists slightly different statistics for what it calls “serious adverse reactions.�� It cites ranges for how frequently various complications occur: 0.03% to 0.5% for transfusion; 0.2% for sepsis and 0.04% to 0.6% for hospitalization related to medication abortions. The ranges reflect findings across various relevant studies, experts said.Why do patients go to the emergency room?Mifepristone's labeling also lists a complication that most medical groups don’t consider a serious or major adverse event: ER visits, which ranged from 2.9% to 4.6%. The current FDA label lists going to the ER as an option if patients experience prolonged heavy bleeding, severe abdominal pain or a sustained fever.But ER visits don’t always reflect big problems, doctors told The Associated Press.Some people may go there after a medication abortion because they want to be checked out or have questions but don’t have a doctor, said Upadhyay, a professor at the University of California, San Francisco. Others, she said, “don’t want to go to their primary care provider about their abortion�� because of stigma.A study she co-authored in 2018 found that slightly more than half of patients who visited the ER because of abortions received only observational care. Some, Upadhyay said, "don’t receive any treatment.�� How effective is the pill?Mifepristone results in a completed abortion 97.4% of the time, according to U.S. studies cited in the FDA label.But in 2.6% of cases, a surgical intervention is needed. And 0.7% of the time, the pregnancy continues.That's compared to a procedural abortion in a clinic, where the chance of the procedure failing to end a pregnancy “is extremely, extremely low,�� probably less than 0.1%, said Dr. Pratima Gupta, a board member for the American College of Obstetricians and Gynecologists.“Any time a procedural abortion is done, the clinicians ensure that it was a complete abortion�� by examining the tissue that is removed or performing an ultrasound during or after the procedure, she said.Gupta, who has done abortion procedures for more than 20 years, said there are "very few complications from abortion �� any kind of abortion, medication or procedural abortion.�� A recent study suggests that's just as true for medication abortions that happen in a clinic, a doctor's office or at home with the help of telehealth.How does mifepristone's safety and effectiveness compare to other drugs?The FDA makes drug approval decisions on a case-by-case basis, weighing effectiveness, safety and other factors.No drug is 100% effective, and many common medications don't work for a significant portion of patients.Antidepressants typically help between 40% and 60% of people with depression. New antibiotics approved by the FDA often resolve about 70% of infections.Since 2000, roughly 6 million patients have taken mifepristone, according to the FDA. A 2021 review of agency records looking for deaths that were likely related to the drug identified 13, or .00027% of patients.Medical organizations supporting mifepristone's availability say the drug's safety �� given the rate of deaths �� compares to “ibuprofen, which more than 30 million Americans take in any given day.��

The U.S. Supreme Court will take up a case Tuesday that could impact how women get access to mifepristone, one of the two pills used in the most common type of abortion in the nation.

The central dispute in the case is whether the Food and Drug Administration overlooked serious safety problems when it made mifepristone easier to obtain, including through mail-order pharmacies.

Legal briefs filed with the court describe the pill's safety in vastly different terms: Medical professionals call it “among the safest medications�� ever approved by the FDA, while the Christian conservative group suing the agency attributes “tens of thousands�� of “emergency complications�� to the drug.

Earlier this year, a medical journal retracted two studies that claimed to show the harms of mifepristone. The studies were cited in the pivotal Texas court ruling that brought the matter before the Supreme Court. The publisher cited conflicts of interest by the authors and flaws in their research, although the studies' lead author called the retractions a baseless attack.

Here’s what to know about the safety of mifepristone, which is typically used with misoprostol in a medication abortion.

What safety limits has the FDA imposed since 2000?

The FDA approved mifepristone in 2000 as a safe and effective way to end early pregnancies.

There are rare occasions when mifepristone can cause dangerous, excessive bleeding that requires emergency care. Because of that, the FDA imposed strict safety limits on who could prescribe and distribute it �� only specially certified physicians and only as part of three mandatory in-person appointments with the patient getting the drug.

The doctors also had to be capable of performing emergency surgery to stop excess bleeding and an abortion procedure if the drug didn't end the pregnancy.

Video below: Get the Facts: 1873 Comstock Act Used in Abortion Pill Decision

Over the years, the FDA reaffirmed mifepristone's safety and repeatedly eased restrictions, culminating in a 2021 decision doing away with any in-person requirements and allowing the pill to be sent through the mail.

How often are there serious problems?

Abortion opponents say the more lax restrictions resulted in many more “emergency complications.�� But that argument lumps together women experiencing a range of issues with mifepristone �� from the drug not working to people who may simply have questions or concerns but don’t require medical care.

OB-GYNs say a tiny fraction of patients suffer “major�� or “serious�� adverse events after taking mifepristone.

A legal brief by a group of medical organizations including the American College of Obstetricians and Gynecologists says: “When used in medication abortion, major adverse events �� significant infection, excessive blood loss, or hospitalization �� occur in less than 0.32% of patients, according to a highly regarded study with more than 50,000 patients."

The definition that scientists generally use for serious adverse events includes blood transfusions, major surgery, hospital admissions and death, said Ushma Upadhyay, one of the authors of that 2015 study. She added: “The hospital admission is a catch-all for the very serious but more rare events such as major infection.��

The prescribing information included in the packaging for mifepristone tablets lists slightly different statistics for what it calls “serious adverse reactions.�� It cites ranges for how frequently various complications occur: 0.03% to 0.5% for transfusion; 0.2% for sepsis and 0.04% to 0.6% for hospitalization related to medication abortions. The ranges reflect findings across various relevant studies, experts said.

Why do patients go to the emergency room?

Mifepristone's labeling also lists a complication that most medical groups don’t consider a serious or major adverse event: ER visits, which ranged from 2.9% to 4.6%. The current FDA label lists going to the ER as an option if patients experience prolonged heavy bleeding, severe abdominal pain or a sustained fever.

But ER visits don’t always reflect big problems, doctors told The Associated Press.

Some people may go there after a medication abortion because they want to be checked out or have questions but don’t have a doctor, said Upadhyay, a professor at the University of California, San Francisco. Others, she said, “don’t want to go to their primary care provider about their abortion�� because of stigma.

A in 2018 found that slightly more than half of patients who visited the ER because of abortions received only observational care. Some, Upadhyay said, "don’t receive any treatment.��

How effective is the pill?

Mifepristone results in a completed abortion 97.4% of the time, according to U.S. studies cited in the FDA label.

But in 2.6% of cases, a surgical intervention is needed. And 0.7% of the time, the pregnancy continues.

That's compared to a procedural abortion in a clinic, where the chance of the procedure failing to end a pregnancy “is extremely, extremely low,�� probably less than 0.1%, said Dr. Pratima Gupta, a board member for the American College of Obstetricians and Gynecologists.

“Any time a procedural abortion is done, the clinicians ensure that it was a complete abortion�� by examining the tissue that is removed or performing an ultrasound during or after the procedure, she said.

Gupta, who has done abortion procedures for more than 20 years, said there are "very few complications from abortion �� any kind of abortion, medication or procedural abortion.�� A suggests that's just as true for medication abortions that happen in a clinic, a doctor's office or at home with the help of telehealth.

How does mifepristone's safety and effectiveness compare to other drugs?

The FDA makes drug approval decisions on a case-by-case basis, weighing effectiveness, safety and other factors.

No drug is 100% effective, and many common medications don't work for a significant portion of patients.

Antidepressants typically help between 40% and 60% of people with depression. New antibiotics approved by the FDA often resolve about 70% of infections.

Since 2000, roughly 6 million patients have taken mifepristone, according to the FDA. A 2021 review of agency records looking for deaths that were likely related to the drug identified 13, or .00027% of patients.

Medical organizations supporting mifepristone's availability say the drug's safety �� given the rate of deaths �� compares to “ibuprofen, which more than 30 million Americans take in any given day.��

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