NC experts, health care providers watch courts as access to abortion drug mifepristone is contested

NC experts, health care providers watch courts as access to abortion drug mifepristone is contested

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By Rachel Crumpler

Medication abortion is the most common method used to end pregnancies nationwide and in North Carolina. For now, the preferred two-medication regimen is still available in the state. But that could change, depending on what happens nationally. 

In 2020, the most recent data available, 14,813 patients living in North Carolina who got abortions opted to take pills to induce them. This accounted for 59.1 percent of all abortions in the state.

The rest of the procedures were done as outpatient surgeries. 

However, continued access to one of two commonly used abortion medications, mifepristone, is uncertain in the wake of two conflicting federal court rulings last week.

A federal judge in Texas issued a ruling on April 7 that overturns the U.S. Food and Drug Administration’s 23-year-old approval of mifepristone. The unprecedented ruling marks the first time in history that a federal judge revoked longtime FDA approval of a medication over the objections of the agency and the drug manufacturer.

The ruling could take effect as soon as April 14, removing a safe and effective health care option, said Beverly Gray, an obstetrician-gynecologist from Duke, during a briefing for reporters Wednesday morning. If it does, Planned Parenthood South Atlantic Communications Director Molly Rivera said its clinics are ready to transition to using another approved medication as soon as Saturday morning so there is no interruption in patient care.

The U.S. Justice Department and the drug’s manufacturer have appealed the decision and are seeking to stay the ruling, meaning the decision would be frozen while the appeal moves forward, potentially to the U.S. Supreme Court. North Carolina Attorney General Josh Stein and 23 other attorneys general are also challenging the ruling.

an orange box containing the abortion medication mifepristone
The most common medication abortion regimen uses two oral drugs: mifepristone and misoprostol. If mifepristone can no longer be used, abortion providers can pivot to using a misoprostol-only medication abortion regimen. Credit: Courtesy of Planned Parenthood Federation of America

“Importantly, this ruling purports to affect the availability of medication abortion nationwide — not just in the states that are trying to criminalize abortion, but altogether,” said Jolynn Dellinger, a visiting lecturer at the Duke Law School, at the briefing. She added that it’s concerning that the judge used his own scientific understanding to displace the reasoning of the experts at the FDA.

In contrast, a federal judge in Washington State issued an order the same day that blocks the FDA from rolling back access to the pills in more than a dozen blue states that brought the lawsuit.

The rulings could prompt further changes in the abortion access landscape, which has already shifted significantly since last summer when the Supreme Court overturned Roe v. Wade. 

Medication abortion remains available, and it will continue to be an option if the ruling takes effect, Gray said.

But Gray fears significant downstream consequences if mifepristone — a medication used for abortions and miscarriage management — is no longer available. The strain on patients and providers who would have fewer options, the creation of uncertainty and confusion and the precedent set for revoking the FDA approval of other medications. 

“I do think that creating chaos, creating confusion is part of the game plan with rulings like this,” Gray said. “We have patients coming to the clinic wondering, ‘Is it still legal?’ Patients are trying to move their appointments up earlier so that they can be seen this week because they want to have a medication abortion.

“We’re just trying to do the best we can,” Gray continued. “We’re physicians. We’re not lawyers. We’re trying to tease through all of these opinions and rulings … to really understand what’s going on — and at the same time practicing medicine and trying to take care of patients. As a physician practicing in the complex family planning world, it’s frustrating, confusing and exhausting all at the same time.”

An alternative exists

To obtain a medication abortion in North Carolina, state law requires patients to get abortion pills from a doctor in person after mandated counseling and a 72-hour waiting period, something most other states don’t require. 

The most common medication abortion regimen uses two oral drugs: mifepristone and misoprostol. The medications can be safely used up until 10 weeks of pregnancy, according to the FDA.

Mifepristone is taken first to block a hormone needed for a pregnancy to develop. Misoprostol is taken a day or so later and is used to empty the uterus by causing cramping and bleeding.

More than 5.6 million people nationwide have used the medication mifepristone to end a pregnancy since its approval by the FDA in 2000. 

When taken, research shows this combination of medication successfully terminates a pregnancy 99.6 percent of the time, with a 0.4 percent risk of major complications and an associated mortality rate of less than 0.001 percent

Research indicates that mifepristone, which went through a four-year FDA review process — is safer than Viagra and Tylenol. Other research shows that abortion is safer than giving birth.

If providers can no longer use mifepristone, an alternative medication abortion regimen using only misoprostol exists, Gray said, though it’s not often the preferred choice.

“If you are going to your doctor for treating anything like high blood pressure, diabetes, you want the medicine that is safe and effective with the least side effects that your doctor recommends to you,” Gray said. “This ruling is basically saying the safest, most effective, most recommended method might be taken away, which is unfortunate.”

A misoprostol-only medication abortion regimen involves taking 12 pills and has been linked to higher rates of side effects, such as diarrhea, fever and chills, and slightly less efficacy than when using mifepristone. 

Research shows misoprostol-only regimens successfully terminate pregnancies approximately 80 percent to 100 percent of the time, with a complication rate of less than 1 percent.

Gray said that the use of a medication that is less effective with potentially more side effects could result in more patients opting for surgical procedures. And if there’s a big shift in demand for surgical procedures, Gray said she doesn’t think there are enough providers to provide that care.

“It’s really a tough climate to be practicing medicine,” said Planned Parenthood’s Rivera. 

She said her organization’s providers “have adjusted day after day, week after week, to be in full compliance with any new decisions or laws that come our way so that we can still be there as much as we can for our patients — and that’s what we’re prepared to do again as early as this weekend so that there’s no disruption in care.”

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