The widely used abortion medication runs a legal risk, despite decades of data supporting its use.
The drug, called mifepristone, is part of a two-drug regimen that can terminate pregnancy, and was used in more than half of all abortions in the United States in 2020. Late last year, a group of anti-abortion doctors and others sued the US food company. drug management, Challenge of initial approval for mifepristone in 2000 and subsequent changes made by the agency to expand access to the drug.
In the lawsuitThey claim that the drug is not safe, that the Food and Drug Administration improperly approved it and failed to follow the science, and that mifepristone is illegal to send through the mail. The US District Court judge who first heard the case sided with the group. Now, the case is being reviewed by the US Fifth Circuit Court of Appeals in New Orleans. On May 17, the Fifth Circuit heard oral arguments regarding the judge’s ruling. The matter may eventually be resolved by the Supreme Court.
But the original scientific evidence used in the FDA approval process provided a clear answer to drug safety, says Thomas Kosasa, MD, an ob-gyn at the University of Hawaii in Honolulu who served on a 1996 committee advising the FDA. “We made sure it was a safe drug,” he says. “It was also effective.”
In the 23 years since the agency approved mifepristone, the drug has amassed a long track record of safety data — in the United States and around the world, says Lauren Owens, MD, an ob-gyn at the University of Washington Medical Center in Seattle. In 2020 in the United States alone, there were approximately 500,000 miscarriages caused by medication, which relied on mifepristone and a second drug, misoprostol, to terminate a pregnancy. Medications are also used to manage miscarriages. And during the coronavirus pandemic, an influx of new safety data supported the findings of previous studies.
“Millions of people have used this drug,” Owens says. She and other doctors and scientists say decades of data show the safety of mifepristone and note that a court decision could affect access to the drug — even in states where abortion is legal. Case comes almost a year After the Supreme Court threw out Roe v. Wade (SN: 6/24/22).
Owens says she worries the court’s decision may override medical experts. “If the FDA can’t say which drugs are safe, where does that stop?” she says.
The US Food and Drug Administration approved Mifepristone 2000. What data did you use to make the decision?
On a hot day in July 1996, a group of doctors and scientists who were part of the FDA’s Reproductive Health Drugs Advisory Committee gathered in Gaithersburg, Maryland, to evaluate the drug Mifepristone, also known as RU-486 as well as Mifeprex. The drug has already been approved in France, England, Sweden and China. The committee’s task was to review data on the drug’s safety and efficacy for ending early pregnancy and to vote on recommending its use in the United States.
These committee meetings usually took place in the FDA offices in Rockville, but this time it was different. This time, the committee members traveled with armed guards. Concern for their safety may have stemmed, in part, from recent violence at abortion clinics in Florida and Massachusetts, Kusasa recalls. The agency held the meeting in a small building north of Rockville. The eight committee members rode in bulletproof vehicles, and police escorts led and trailed the group.
The meeting was open to the public, but security was tight. Visitors went through metal detectors and had their bags checked. People crowded to hear the measures, says panelist Diana Petetti, a physician and epidemiologist who retired from the University of Arizona College of Medicine in Phoenix in 2017. “It was absolutely full,” she recalls. The FDA has set up an overflow room nearby for the public to watch the meeting on video.
Then-FDA Commissioner David Kessler opened the meeting with clear instructions to the committee: “What you need to do today is focus on the science,” he said. text. “Examine the clinical data carefully. Ask the tough questions and then give the FDA the best scientific advice based on the data.”
The data came from two clinical trials in France and an ongoing trial in the United States. The French trials included 2,480 women, most of whom were seven weeks pregnant or younger. Doctors used a dose of mifepristone followed by misoprostol two days later, if needed, to terminate the pregnancy. Mifepristone blocks the hormone progesterone, which causes the lining of the uterus to break down. The misoprostol causes contractions that help dislodge the broken tissue.
In French trials, this treatment regimen worked in about 95 percent of women, with few serious side effects, such as severe bleeding. Many women report painful contractions, and some have experienced nausea, vomiting, or diarrhea. These are expected side effects of the medication, Petetti says. “But nothing has emerged as something we should really worry about.” All in all, she says, “the security question was pretty straightforward.”
The committee took a day to discuss mifepristone and voted 6 to 0 that the benefits outweighed the risks. Two members abstained from voting.
After multiple rounds of reviews, the FDA finally followed the committees’ advice and approved mifepristone in 2000, with some restrictions in place. Notably, people can take the drug up to seven weeks of pregnancy, but only under a doctor’s supervision. Patients had to report to the office three times – once for mifepristone, once for misoprostol and then again for a follow-up visit.
Petiti says she is amazed that the safety of mifepristone has been questioned. “I’m just waiting for someone to show me evidence that shows something different than the evidence I saw in 1996.”
Doctors collected data on mifepristone during the coronavirus pandemic. This is what they found.
Since the approval of mifepristone, the FDA has relaxed some of its original restrictions. A 2016 update allowed the drug to be used up to 10 weeks into pregnancy and required only one clinic visit instead of three. Then, the coronavirus pandemic spurred another change that allowed people to access mifepristone by mail, without ever coming to a clinic in person.
The Food and Drug Administration (FDA) updates have given scientists a new way to investigate a drug’s safety, specifically whether or not previous restrictions made people safer. Visiting the clinic was one of those restrictions being lifted, says Ochma Upadhyay, a public health scientist at the University of California, San Francisco.
Even without a typical pre-abortion ultrasound or pelvic exam, The drug was 95% effective in terminating pregnancies and serious complications were rareShows data Upadhyay and colleagues collected from February 2020 through January 2021 on nearly 4,000 people across the United States. The study “confirms that mifepristone is very safe and very effective,” she says.
The findings echo data from other countries, including a huge study from the United Kingdom that analyzed the records of more than 18,000 telemedicine patients who had aborted medication. Medications were 99 percent of active and serious outcomes, such as a blood transfusion or major surgery, occurred in only 0.02 percent of peoplethe researchers reported in 2021.
Upadhyay says the latest data suggests that doctors can safely prescribe mifepristone, without any special testing.
This is how prescriptions work in Canada, where mifepristone became widely available in late 2017. “Canada’s drug regulators have taken the truly unprecedented step of treating mifepristone as any drug,” says Laura Schumers, an epidemiologist at the University of British Columbia in Canada. last”. Vancouver. This means any doctor or nurse practitioner can prescribe mifepristone, any pharmacy can dispense it, and patients can take the medication at home “if, when and where they choose,” she said.
within a few years, The percentage of surgical abortions in Canada has dropped from 98 percent to about 69 percent. By early 2020, more than 30 percent of first-trimester abortions were saved using the medication, Schumers’ team reported in New England Journal of Medicine in 2022. The scientists also analyzed safety trends. “The take home message was that there was absolutely no change in safety outcomes,” Schumers says.
Her team’s paper adds to the body of studies demonstrating the safety of mifepristone. She points out that medical abortion is safer than childbirth, which can be fatal. As scientists reported this year, the us Maternal deaths continue to rise (SN: 3/16/23).
Upadhyay says that in the United States, access to abortion is already difficult, especially for people of color and those on low incomes. She says any decision to restrict or ban mifepristone “would be devastating for people who need the care most.”
In April, the Supreme Court ruled that the property be left available for use while the Fifth Circuit case proceeds. But the appeals court’s decision may not be the final word; The Supreme Court may end up having the final say.
This judicial drug review is of interest not only to Owens of the University of Washington, but also to Koussa. He worries about what the outcome of the case will mean for the FDA, and the agency’s ability to evaluate and approve drugs — even drugs, such as mifepristone, with a well-supported safety record.
If the courts can dispute “a massive amount of scientific evidence, it just doesn’t look right,” Kosasa says.