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Debate over the abortion pill mifepristone resurfaces after Makary confirmed to head the FDA

Debate over the abortion pill mifepristone resurfaces after Makary confirmed to head the FDA
THE SUPREME COURT, IN A UNANIMOUS DECISION, PRESERVED ACCESS TO THE ABORTION DRUG MIFEPRISTONE, REPRODUCE RIGHTS REMAIN A KEY FOCUS IN THE PRESIDENTā€™S RACE WITH THIS DECISION. WITH THIS DECISION, DID THE COURT BLUNT A DEMOCRATIC RALLYING POINT AND GIVE SOME COVER TO REPUBLICANS? ROB, I THINK IT DID. IT TAKES SOME AIR OUT OF THE TIRES OF DEMOCRATS WHO ARE POINTING TO TO DRIVE THE CHOICE ISSUE AT THE POLLS AND BE TRUMP. MARIANNE. NO, NO AND NO, NO, NO. I MEAN, FIRST OF ALL, PUBLIC SERVICE REMINDER, MIFEPRISTONE SAFER THAN VIAGRA. ONE, TWO WHEN THEY KICKED THIS CAN DOWN THE ROAD, THEY DIDNā€™T SAY YOU COULD HAVE IT ANY TIME. YOUā€™RE GOING TO BE ABLE TO GET IT WHEN YOU WANT. THEY DID IT ON A TECHNICALITY. THE WRONG PEOPLE FILED THE SUIT. THAT WAS THE PROBLEM. DEMOCRATS ARE GOING TO OWN THIS ALL DAY LONG. ALL RIGHT. DONALD TRUMPā€™S VETTING PROCESS FOR A VP CONTINUES. JD VANCE, MARCO RUBIO, DOUG BURGUM, ALL AMONG THE NAMES THAT KEEP COMING UP. DOES IT EVEN MATTER, THOUGH? BECAUSE ISNā€™T IT ALL ABOUT TRUMP, MARION? HE ONLY USES HIS VP TO TRY TO OVERTURN AN ELECTION. SO NO, IT DOESNā€™T MATTER. WHAT DO YOU THINK? I MEAN, FIRST OF ALL, ITā€™S A SAD DISPLAY OF KISSING UP FROM THESE GUYS. MANY OF THEM WERE ANTI-TRUMP, VEHEMENTLY ED. NOW THEYā€™RE LIKE, OH, DONALD TRUMP IS THE BEST, BUT IT MATTERS LESS THAN IT USED TO MATTER IN HISTORY, WHERE THE VP IS FROM DRIVING THE TICKET DOESNā€™T HAPPEN. MATTERS MATTERS LESS. NOW MATTERS A LOT. USED TO BE AT A DIFFERENT REGION. YOU COULDNā€™T. YOU COULDNā€™T BLEND. NOW YOU CAN. ALL RIGHT. WEā€™LL WRAP THINGS UP WITH BEST OR WORST WEEK. MARY ANN. GO FIRST. WORST WEEK DONALD TRUMP RETURNED TO THE SCENE OF THE CRIME. THE CAPITOL, WHERE HE LED A COUP ON JANUARY 6TH. THE SAME REPUBLICAN SENATORS AND REPRESENTATIVES WHO LIVES WERE THREATENED, AND THEY CONDEMNED HIM THAT DAY ON THURSDAY, PRAISED HIM AND KISSED HIM LITERALLY. IF THEY WONā€™T STAND UP TO TRUMP OR FOR THEMSELVES, THEYā€™RE CERTAINLY NOT GOING TO STAND UP FOR YOU. BEST AT WORST. ROB, I DONā€™T KNOW MUCH ABOUT MILWAUKEE BEYOND LAVERNE AND SHIRLEY. WE MISSED THEM. LENNY AND SQUIGGY, BUT I KNOW THAT THE CITY OF MILWAUKEE HAD A GOOD WEEK BECAUSE TRUMP INSULTED THE CITY, CALLED IT A HORRIBLE CITY DESPITE PLANNING TO HOLD HIS CONVENTION THERE. EVERYBODYā€™S COME TO MILWAUKEEā€™S DEFENSE. ITā€™S A GREAT PLACE. GREAT ARTS. GOOD WEEK FOR MILWAUKEE GUYS. THANK YOU, JOHN ATWATER, AND
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Debate over the abortion pill mifepristone resurfaces after Makary confirmed to head the FDA
Many Americans wonder whether the pill used in most U.S. abortions will be restricted under the new Republican administration in Washington.President Donald Trumpā€™s pick to lead the Food and Drug Administration, Dr. Marty Makary, was confirmed by the Senate late Tuesday. In recent testimony before the Senate health committee, Makary wouldnā€™t commit to specific action on the pill, called mifepristone, despite prodding from both Republicans and Democrats.Medical professionals call it ā€œamong the safest medicationsā€ ever approved by the FDA. But a Christian conservative group that sued the FDA over the drug says it has caused ā€œtens of thousandsā€ of ā€œemergency complications."Hereā€™s what to know about the safety of mifepristone, which is typically used with misoprostol in medication abortions that make up close to two-thirds of abortions in the U.S.What are the safety limits on use of the abortion pill?The FDA approved mifepristone in 2000 as a safe and effective way to end early pregnancies. Currently, there are no in-person requirements and the pill can be sent through the mail.That's not how the FDA first treated mifepristone, which on rare occasions can cause dangerous, excessive bleeding that requires emergency care. Strict safety limits were placed on who could prescribe and distribute it ā€” 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 didnā€™t end the pregnancy.Over time, the FDA reaffirmed mifepristoneā€™s safety and repeatedly eased restrictions.How often are there serious problems?Abortion opponents say the FDAā€™s 2021 decision allowing online prescribing and mail-order use of mifepristone resulted in many more ā€œemergency complications.ā€But that argument lumps together women experiencing a range of issues ā€” from mifepristone not working to people who may simply have questions or concerns but donā€™t require medical care.OB-GYNs say a tiny fraction of patients suffer ā€œmajorā€ or ā€œseriousā€ adverse events after taking mifepristone.A legal brief filed with the Supreme Court last year by a group of medical organizations including the American College of Obstetricians and Gynecologists says: ā€œWhen used in medication abortion, major adverse events ā€” significant infection, excessive blood loss, or hospitalization ā€” occur in less than 0.32% of patients, according to a highly regarded study with more than 50,000 patients.ā€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.The prescribing information included in the packaging for mifepristone tablets lists slightly different statistics for what it calls ā€œserious adverse reactions.ā€ 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?Mifepristoneā€™s labeling lists a complication that most medical groups donā€™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 donā€™t always reflect big problems.Some people may go there after a medication abortion because they want to be checked out or have questions but donā€™t have a doctor, said Upadhyay, a public health scientist at the University of California, San Francisco. Others, she said, ā€œdonā€™t want to go to their primary care provider about their abortionā€ 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.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.Thatā€™s compared to a procedural abortion in a clinic, where the chance of the procedure failing to end a pregnancy ā€œis extremely, extremely low,ā€ probably less than 0.1%, said Dr. Pratima Gupta, a board member for the American College of Obstetricians and Gynecologists.ā€œAny time a procedural abortion is done, the clinicians ensure that it was a complete abortionā€ 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 ā€œvery few complications from abortion ā€” any kind of abortion, medication or procedural abortion.ā€One study suggested thatā€™s just as true for medication abortions that happen in a clinic, a doctorā€™s office or at home with the help of telehealth.How does mifepristoneā€™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 donā€™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 0.00027% of patients.Medical organizations supporting mifepristoneā€™s availability say the drugā€™s safety ā€” given the rate of deaths ā€” compares to ā€œibuprofen, which more than 30 million Americans take in any given day.ā€

Many Americans wonder whether the pill used in most U.S. abortions will be restricted under the new Republican administration in Washington.

President Donald Trumpā€™s pick to lead the Food and Drug Administration, Dr. Marty Makary, was confirmed by the Senate late Tuesday. In recent testimony before the Senate health committee, Makary wouldnā€™t commit to specific action on the pill, called mifepristone, despite prodding from both Republicans and Democrats.

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Medical professionals call it ā€œamong the safest medicationsā€ ever approved by the FDA. But a Christian conservative group that sued the FDA over the drug says it has caused ā€œtens of thousandsā€ of ā€œemergency complications."

Hereā€™s what to know about the safety of mifepristone, which is typically used with misoprostol in medication abortions that make up close to two-thirds of abortions in the U.S.

What are the safety limits on use of the abortion pill?

The FDA approved mifepristone in 2000 as a safe and effective way to end early pregnancies. Currently, there are no in-person requirements and the pill can be sent through the mail.

That's not how the FDA first treated mifepristone, which on rare occasions can cause dangerous, excessive bleeding that requires emergency care. Strict safety limits were placed on who could prescribe and distribute it ā€” 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 didnā€™t end the pregnancy.

Over time, the FDA reaffirmed mifepristoneā€™s safety and repeatedly eased restrictions.

How often are there serious problems?

Abortion opponents say the FDAā€™s 2021 decision allowing online prescribing and mail-order use of mifepristone resulted in many more ā€œemergency complications.ā€

But that argument lumps together women experiencing a range of issues ā€” from mifepristone not working to people who may simply have questions or concerns but donā€™t require medical care.

OB-GYNs say a tiny fraction of patients suffer ā€œmajorā€ or ā€œseriousā€ adverse events after taking mifepristone.

A filed with the Supreme Court last year by a group of medical organizations including the American College of Obstetricians and Gynecologists says: ā€œWhen used in medication abortion, major adverse events ā€” significant infection, excessive blood loss, or hospitalization ā€” occur in less than 0.32% of patients, according to a highly regarded study with more than 50,000 patients.ā€

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 .

The prescribing information included in the packaging for mifepristone tablets lists slightly different statistics for what it calls ā€œserious adverse reactions.ā€ 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?

Mifepristoneā€™s labeling lists a complication that most medical groups donā€™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 donā€™t always reflect big problems.

Some people may go there after a medication abortion because they want to be checked out or have questions but donā€™t have a doctor, said Upadhyay, a public health scientist at the University of California, San Francisco. Others, she said, ā€œdonā€™t want to go to their primary care provider about their abortionā€ 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.

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.

Thatā€™s compared to a procedural abortion in a clinic, where the chance of the procedure failing to end a pregnancy ā€œis extremely, extremely low,ā€ probably less than 0.1%, said Dr. Pratima Gupta, a board member for the American College of Obstetricians and Gynecologists.

ā€œAny time a procedural abortion is done, the clinicians ensure that it was a complete abortionā€ 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 ā€œvery few complications from abortion ā€” any kind of abortion, medication or procedural abortion.ā€

One suggested thatā€™s just as true for medication abortions that happen in a clinic, a doctorā€™s office or at home with the help of telehealth.

How does mifepristoneā€™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 donā€™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 0.00027% of patients.

Medical organizations supporting mifepristoneā€™s availability say the drugā€™s safety ā€” given the rate of deaths ā€” compares to ā€œibuprofen, which more than 30 million Americans take in any given day.ā€