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What to make of all the talk about using misoprostol alone for abortion if mifepristone is limited

by | Apr 21, 2023

By Randall K. O’Bannon, NRL Director of Education & Research

Editor’s note. It’s uncanny how well Dr. O’Bannon anticipated what the Abortion Industry and its friends in the media would say about the “abortion pill.” This ran last Friday.

Today, Niha Masih of the Washington Post conceded misoprostol used alone was less effective and “can be more painful and take more time.”

Ushma Upadhyay, “a reproductive health and abortion safety expert,” told Masih “Misoprostol alone also results in greater side effects, specifically nausea, vomiting and diarrhea. Patients can also expect longer days of bleeding, so the abortion process may be prolonged.”

When the U.S. Food and Drug Administration (FDA) approved the abortion pill mifepristone for sale in September of 2000, it did so with a protocol that included another drug, misoprostol.  Mifepristone was taken the first day to block the pregnancy hormone progesterone and essentially starve the baby to death, and then, a day or so later, women were to take the prostaglandin misoprostol to stimulate powerful contractions to expel the dying or dead child.

Misoprostol had been approved by the FDA a dozen years earlier, not for abortion, but as an effective anti-ulcer medication for people taking lots of NSAIDS (non-steroidal anti-inflammatory drugs). Because of its effect on the uterus, misoprostol has always carried the FDA’s “black box warning” on its official label, advising pregnant women that use of the drug could threaten their pregnancies.

It was cheap and widely available, so physicians and others who were aware of these abortifacient properties with access to these drugs began to secretly prescribe or sell these to women who were seeking to chemically end their pregnancies, particularly in countries where abortion was not legal or mifepristone was not available.

With abortion now illegal in some U.S. states and a lawsuit proceeding through the federal court system threatening to pull mifepristone’s approval as an abortifacient or otherwise limit the abortion pill’s availability, many in the abortion industry are threatening to turn to misoprostol as a way of getting around the law.

Some have already done so. Carafem, a high end abortion chain with four brick and mortar locations (Chicago, Washington, DC, Atlanta, Nashville) and a brisk online abortion business, began offering misoprostol only abortions as an option in 2020.  Carafem said 80 percent of its patients opted for misoprostol alone when the Supreme Court briefly reinstated the requirement that patients pick up mifepristone in person at the clinic after the FDA had suspended that requirement during the pandemic. During that time, Carafem mailed the misoprostol when it could not legally do so with mifepristone (Slate, 2/13/23).

Governors in California and New York have both announced plans in the last few days to stockpile misoprostol in case the supply of mifepristone is interrupted. New York Governor Kathy Hochul says her state is planning to buy a five year supply, while California Governor Gavin Newsom says they plan to stock up to 2 million pills of the drug.

Here’s what you should know about abortion with misoprostol alone:

Does misoprostol work as an abortifacient? Is it safe?

Of course, it strains logic and language to call any pill that regularly and intentionally kills human beings “safe.”  But if someone is asking whether misoprostol “successfully” aborts an unborn child without killing his or her mother, the answer is it “works” to give a complete abortion maybe 76-78% of the time and most of the women do not die or suffer permanent physical injury (Ngoc, Contraception, 2011; E. Raymond, ObstetGynecol, 2019).

This makes misoprostol considerably less “effective” than the 93-97% rate claimed by the mifepristone-misoprostol combination, but it is still effective enough for an abortion industry looking for a cheap workaround where mifepristone supply is limited.

This does not mean that these abortions are easy, comfortable, or without risk. Painful cramps and bleeding are still standard parts of the package, but may last longer for women using misoprostol by itself. Patients using misoprostol to abort are also likely to experience more nausea, vomiting, and diarrhea. There is a greater likelihood of failure or incomplete abortion. 

All of these side effects are known to have put some women in the hospital.  Chemical abortions are nevereasy or comfortable, butmay be even less so with misoprostol alone.

Are misoprostol abortions legal?

As mentioned above, the FDA gave misoprostol (under the trade name Cytotec), approval in 1988 as an anti-ulcer drug for patients who take a lot of NSAIDS. That is the only purpose for which this drug, on its own, has ever been officially approved by the FDA.*

Once a drug has FDA approval, however, it is available on the market and any licensed physician can legally prescribe that medication for any purpose or application he or she sees fit. So it can and has been legally prescribed by some abortionists for this deadly purpose.

But this does not necessarily mean that the prescriber can avoid legal or financial consequences.

Prescribing a pill outside its designated boundaries exposes the doctor to charges of malpractice when something goes wrong, when the drug fails or triggers serious complications, as the abortionist does not have the FDA’s backing as to the drug’s safety or efficacy for that particularly use.

State or federal laws protecting unborn children or otherwise prohibiting chemical abortions would also make the prescription or mailing of misoprostol for this purpose illegal. Under such circumstances, a physician could not legally dispense misoprostol for abortion and a pharmacy receiving a prescription specifying its use for this purpose could not legally fill it.

Are misoprostol abortions cheaper, easier to get?

Misoprostol, available at less than a dollar a pill, is considerably cheaper than mifepristone. Good Rx says the generic for mifepristone can be bought at an average retail price of just over $83 a pill. 

Because it is a proven anti-ulcer drug which has been on the market for a number of years and is regularly stocked in pharmacies, misoprostol is more familiar and more widely available, even in states or in countries where the abortifacient mifepristone is not legal or publicly sold.

Abortion advocates know this and have counseled women and doctors on ways to exploit cracks in the system. They suggest pregnant women seeking chemical abortions find doctors to write prescriptions for them to get pills to help with their “ulcers”; they recommend these women try and persuade pharmacists to give her a few pills for “a visiting aunt who forgot her prescription.” They tell women how to order these pills online or just advise them to pick up these misoprostol pills on the black market.

Can anything be done to stop the use of misoprostol for abortion?

Because misoprostol’s official approval is only as a legitimate anti-ulcer drug, and not as a stand-alone abortifacient, there is no reason for the FDA to rescind this approval and pull the drug from the market.

However, that does not mean that nothing can be done.

In states where abortion is legal, doctors could still probably prescribe these drugs off label for abortion, whether mifepristone is still available or not (due to as yet unresolved issues currently winding their ways through the courts). But again, those who do so could face legal liability if something goes wrong and the woman suffers injury, since the prescriber lacks the FDA’s authorization for this use.

The encouragement of these lawsuits could be a real disincentive for those considering prescribing misoprostol for abortion.

States passing blanket protections for unborn children or with laws generally prohibiting the prescription, sale, or use of chemical abortifacients would also give the state the authority to prosecute those prescribing mifepristone, misoprostol or any other drug for the purpose of aborting unborn children. (NRLC does not support any laws that would prosecute women for using these pills.)

While use or prescription of any of these medications for legitimate (non-abortifacient) medical purposes would continue to be allowed, evidence that misoprostol or any other drugs were being prescribed to chemically induce abortion would, at a minimum, prompt an investigation and give pharmacies reason to deny filling these prescriptions.

It might be useful, under these circumstances, for states to pass laws or regulations requiring that prescribers indicate the intended purpose for the drugs on their prescription forms. This would put physicians in the position of having to officially declare their intentions, making them either own up to the true abortifacient intent of their prescription or risk being held criminally liable for falsifying their orders.

None of this would conclusively stop the abuse of these drugs for these deadly purposes, but it could make an abortionists think twice before writing out one of these prescriptions.

*Misoprostol was, of course, included in the protocol the FDA approved for mifepristone in 2000, but the FDA did not make any change reflecting that on misoprostol’s own label.

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