Prescribed Abortions Are Practically Safe and Effective: California Study

The abortion drug Mifepristone, also known as RU486, is pictured at an abortion clinic on February 17, 2006 in Auckland, New Zealand

The abortion drug Mifepristone, also known as RU486, is pictured at an abortion clinic on February 17, 2006 in Auckland, New Zealand
Photo: Phil walter (Getty Images)

New research shows that abortions prescribed over the phone or online can be safe and effective. The study found that a large majority of women who had medical abortions in California last year via a telehealth service required no medical follow-up and no major adverse events were reported. The results may be particularly relevant given a pending decision by the Food and Drug Administration on whether it will permanently lift the requirement for dispensing abortion drugs in a doctor’s office.

Medical abortion is usually performed with a two-drug combination of mifepristone and misoprostol, taken in the first 10 weeks of pregnancy. Mifepristone has been the subject of a Risk Assessment and Mitigation Strategy (REMS), an FDA-imposed restriction on how a drug can be used. This restriction requires that patients receive mifepristone dispensed by a hospital, clinic or doctor’s office, which in effect means that it must be provided in person (often patients are also told to receive in-person counseling and / or an ultrasound examination). Although the stated rationale for this restriction was the fear that these drugs could routinely cause serious health complications such as major bleeding, subsequent research in the United States and elsewhere has failed. door dispel this concern.

For years, women’s health advocates and scientists have called for lifting the REMS on mifepristone, along with other unnecessary burdens on abortion care. And when the covid-19 pandemic hit, resulting in many restrictions on in-person services, the American College of Obstetricians and Gynecologists, and others for follow-up the FDA in federal court to obtain the temporary suspension of the program. Shortly after, in July, the court issued an injunction that lifted the ban for the duration of the pandemic being a public health emergency. The FDA, then under the Trump administration, fought the injunction, appealing to the Supreme Court. In January of this year, the court granted the FDA’s wish and overturned the decision. However, the newly installed Biden administration went on to reverse course, and, in April 2021, the FDA issued guidelines temporarily lifting the REMS restriction.

Between all these round trips, various telehealth services were able to dispense abortion drugs remotely throughout the second half of 2020. This new study, published Tuesday in the JAMA Network Open, focuses on the outcomes of California patients who received abortion care through a virtual clinic called Choice.

In total, the researchers examined the anonymized records of 141 patients between October 2020 and January 2021. Of these, 81% had data on their results. And of those, 95% said they had had a complete abortion without any further medical intervention being necessary. Five patients (5%) requested additional care, two to an emergency department. But no major adverse event has been reported by any patient.

“This research demonstrates that medical abortion provided by telehealth and dispensed to patients through the mail order pharmacy is safe and effective,” said lead study author Ushma Upadhyay, associate professor at the University of California at San Francisco. Advance new standards in reproductive health, Bixby Center for Global Reproductive Health. “FDA Policywould be based on the latest medical evidence. It’s time for the FDA to permanently end regulations for the in-person dispensing of mifepristone. “

Results are based on a small sample size and limited to patients from a single clinic, so they should be validated further. But the researchers note that an initial success rate of 95% is similar to what is seen when the drug is dispensed in person, as well as the rates seen at telehealth programs In other countries. And they should certainly provide important data to guide the FDA’s decision to completely lift the REMS ban on mifepristone.

Even though the FDA is removing the requirement for in-office prescribing, it require a new lawsuit to overturn state bans on telehealth abortions, which may ultimately fail, given the conservative lean of the Supreme Court and its earlier ruling this year. He stays many obstacles reliable and timely abortion care, in some states more than others. But the lifting of the REMS would nevertheless represent a real step forward for women’s health in the United States


Leave A Reply