Mifepristone is not safe

OPINION:

With Robert F. Kennedy Jr.’s confirmation as health and human services secretary, many Americans are hopeful that improved health care transparency is on the horizon. They acutely recognize the need to end medical misinformation from many leaders and institutions.

Anyone who watched Mr. Kennedy’s Senate confirmation hearings can see why.

Sen. Ron Wyden claimed that the abortion drug “mifepristone is safe.”

The next day, Sen. Tammy Baldwin noted several studies showing mifepristone’s safety but ignored the problems with these studies and the clinical evidence that shows otherwise.

Their statements echo the language used by the politicized Food and Drug Administration to understate the risks of mifepristone.

The senators’ statements also echo a common lie of the abortion industry: that mifepristone is safer than Tylenol. That is not true.

Informed by my 20 years of caring for women as an OB/GYN physician, I believe it is critical that American women who look to our national health leaders for guidance be equipped with the truth about mifepristone.

The fact of the matter is that mifepristone holds the risk of deadly complications, including hemorrhage and sepsis. The drug’s label includes a black box warning to highlight the most serious risks because mifepristone can cause “serious and sometimes fatal infections and bleeding.” The FDA’s medication guide for the drug notes that up to 7% of women will need surgery after taking mifepristone “to stop bleeding” or to fully achieve the abortion. The list of dangers goes on and on.

Because of these hazards, the FDA strictly regulated how mifepristone was dispensed when it initially approved it in 2000. These regulations included an in-person doctor visit to confirm how far along the woman’s pregnancy was and rule out ectopic pregnancy, which is life-threatening and can mimic the drug’s side effects. Additionally, it was used only for women seven weeks pregnant or less, and follow-up care was required to ensure any possible complications were addressed immediately.

Despite these risks, the Obama and Biden FDA recklessly relaxed these safeguards under pressure from abortion advocates, now allowing this dangerous drug to be dispensed online, thereby denying women the minimum standards they deserve to protect their health.

Under today’s neglectful standards, mifepristone can be sent to women by mail without any in-person consultation with a doctor to rule out these risks. After taking mifepristone in their homes, women are left alone to manage their abortions without any ongoing care from a physician. This protocol puts women at risk of ingesting counterfeit drugs with unknown effects, denies them the chance to be screened for life-threatening conditions such as ectopic pregnancy, and exposes them to coercion from abusive partners and forced abortions.

Additionally, the FDA stopped requiring reporting of any serious side effects from the drug other than death, so women can’t possibly receive accurate information on the true impact of the drug.

The tragic deaths of two women shortly after the FDA removed its reasonable safeguards point to what can go wrong without adequate medical supervision before and after taking mifepristone. In her ninth week of pregnancy, young mother Amber Thurman took abortion pills and then drove back across state lines to her home state of Georgia with no follow-up care arranged.

During the next several days, she developed severe complications known to be associated with mifepristone, including hemorrhage, retained tissue and sepsis. These complications and the delay in care for them caused her death. That same year, Candi Miller, another mother in Georgia, died from taking mail-order abortion drugs without any medical oversight.

Our government leaders must stop selling women the lie that this drug is safe when it’s evident that the very opposite is true. Otherwise, tragedy will continue to ensue.

Any competent physician knows this is the case. After the FDA’s regulatory relaxation in 2021, I asked a pro-choice colleague of mine what she would say to a patient who called and thought she was having a miscarriage. “Would you call in medication without ever seeing her in person, doing an ultrasound or running labs?” I asked.

My colleague incredulously said, “No, of course not; that would be medical malpractice.”

The FDA caved to the demands of the abortion lobby and now denies women essential and potentially lifesaving care by allowing these drugs to be dispensed without a physician visit or follow-up.

Regardless of one’s views on abortion, American women deserve the truth about abortion drugs and their side effects. That requires a renewed commitment to examining these drugs’ real-life impacts and reinstating essential safeguards. In short, we need better data reporting and an FDA willing to do its job.

Fortunately, in his Senate confirmation hearings, Mr. Kennedy highlighted the vital importance of understanding the adverse effects and the safety of drugs such as mifepristone. I agree that it’s un-American to be against data transparency on this issue.

Public health officials, physicians and, most important, vulnerable patients deserve timely, accurate and accessible information about abortion drugs. The health and well-being of my patients depend on it.

• Christina Francis is a board-certified obstetrician-gynecologist practicing as an obstetric hospitalist. She also serves as CEO of the American Association of Pro-Life Obstetricians and Gynecologists.