North Carolina experts and healthcare providers watch courts as access to abortion drug mifepristone is challenged [Beuzz]

North Carolina Experts And Healthcare Providers Watch Courts As Access To Abortion Drug Mifepristone Is Challenged

By Rachel Crumpler

Medical abortion is the most common method used to end a pregnancy at national scale and in North Carolina. For now, the preferred two-drug 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 had abortions chose to take pills to induce them. This represented 59.1% of all abortions in the state.

The rest of the procedures were performed on an outpatient basis.

However, continued access to one of two commonly used abortion drugs, mifepristone, is uncertain following two contradictory Federal Court decisions last week.

A federal judge in Texas issued a ruling on April 7 that reverses the US Food and Drug Administration’s 23-year-old approval of mifepristone. The unprecedented decision marks the first time in history that a federal judge has revoked the FDA’s longstanding drug approval over objections from the agency and the drug’s manufacturer.

The decision could take effect as early as April 14, removing a safe and effective healthcare option, said Beverly Gray, an obstetrician-gynecologist at Duke, during a briefing for journalists on Wednesday morning. If so, Planned Parenthood South Atlantic communications director Molly Rivera said her clinics are ready to switch to using another approved drug as early as Saturday morning so there’s no disruption of patient care.

The US Department of Justice and the drug’s manufacturer have appealed decision and are seeking to stay the decision, which means the decision would be frozen while the appeal progresses, potentially to the United States Supreme Court. North Carolina Attorney General Josh Stein and 23 other attorneys general are also contest the judgment.

The most common medical abortion regimen uses two oral medications: mifepristone and misoprostol. If mifepristone can no longer be used, abortion providers can switch to a misoprostol-only medical abortion regimen. Credit: Courtesy of Planned Parenthood Federation of America

“It is important to note that this decision is intended to affect the availability of medical abortion nationwide – not just in states that attempt to criminalize abortion, but overall,” said Jolynn Dellinger, guest speaker at the Duke Law School, during the briefing. She added that it is concerning that the judge used his own scientific understanding to dismiss the reasoning of the FDA experts.

In contrast, a Washington state federal judge issued an order the same day that prevents the FDA from reducing access to the pills in more than a dozen blue states that filed the lawsuit.

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

Medical abortion remains available and will continue to be an option if the decision takes effect, Gray said.

But Gray fears significant downstream consequences if mifepristone – a drug used for abortions and the management of miscarriages – is no longer available. The pressure on patients and providers who would have fewer options, the creation of uncertainty and confusion, and the precedent set to revoke FDA approval for other drugs.

“I think creating chaos, creating confusion is part of the game plan with decisions like this,” Gray said. “We have patients who come to the clinic wondering, ‘Is this still legal?’ Patients try to bring their appointments forward earlier so they can be seen this week because they want to have a medical abortion.

“We just try to do our best,” Gray continued. “We are doctors. We are not lawyers. We’re trying to understand all of these opinions and decisions… to really understand what’s going on – and at the same time practice medicine and try to take care of patients. As a physician practicing in the complex world of family planning, it is frustrating, confusing, and exhausting all at once.

An alternative exists

To obtain a medical abortion in North Carolina, state law requires patients to obtain abortion pills from a physician in person after mandatory counseling and a 72-hour waiting period, which most other states do not require.

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

Mifepristone is taken primarily to block a hormone needed for a pregnancy to develop. Misoprostol is taken about a day later and is used to empty the uterus causing cramping and bleeding.

More … than 5.6 million people across the country have used the drug mifepristone to end a pregnancy since it was approved by the FDA in 2000.

When taken, research shows that this drug combination successfully ends a pregnancy 99.6% of the time, with a 0.4% risk of major complications and mortality rate of less than 0.001 percent.

Research indicates that mifepristone, which has undergone a four-year review process by the FDA, 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 medical abortion regimen using only misoprostol exists, Gray said, although it’s often not the preferred choice.

“If you’re going to your doctor to treat something like high blood pressure, diabetes, you want the safe, effective drug with the fewest side effects that your doctor recommends,” Gray said. “This decision basically says that the safest, most effective and most recommended method could be removed, which is unfortunate.”

A misoprostol-only medical abortion regimen involves taking 12 tablets and has been linked to higher rates of side effectssuch as diarrhea, fever and chills, and slightly less effective than mifepristone.

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

Gray said using a less effective drug with potentially more side effects could lead more patients to opt for surgeries. And if there’s a big shift in demand for surgeries, Gray said she doesn’t think there are enough providers to provide that care.

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

She said her organization’s providers “have been adjusting day by day, week by week, to be in full compliance with any new rulings or laws that come our way so that we can always be there as much as possible for our patients – and that’s what we are ready to start again this weekend so that there is no interruption of care.

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