WASHINGTON — New recommendations for the abortion pill announced Wednesday by the Food and Drug Administration could increase use of the medication to terminate a pregnancy in the United States.
The new label changes the recommended dosage of the two drugs used in the abortion process. It allows the treatment to be used up to 70 days into pregnancy – three weeks longer than the old guidelines. And it relaxes prescriber guidelines to allow, for example, a nurse practitioner to administer the drugs rather than a physician.
The reality on the ground will not change for most abortion patients, as doctors for years have been legally diverging from the old FDA protocol based on new research. But a handful of states, including Texas and Ohio, have laws requiring abortion providers to adhere at least in part to the FDA-approved label, leading some providers there to all but abandon the use of the abortion pill.
“The label change for medication abortion will mean that it will once again be a real option for Preterm’s patients and women across the state,” Chrisse France, executive director of Preterm, an abortion provider in Ohio, said in a statement. “We will no longer be forced to practice medicine mandated by politicians whose ultimate goal is to shut us down.”
Anti-abortion groups noted that the new label carries over the old label’s warnings of some of the dangers associated with the drug – including the very rare possibility of infection or death.
“The new label affirms the deadly realities of chemical abortion and underscores the need for in-person patient examination and follow-up care as well as the fact that the abortion drug regimen presents serious risks to women’s health,” Anna Paprocki, staff attorney for Americans United for Life, said in a statement.
The label change is effective immediately. It applies to Mifeprex, which is the brand name for mifepristone, one of the two drugs used in medication abortions. It blocks the production of progesterone, a hormone that prepares the lining of the uterus for a fertilized egg. A day or two after taking that drug, the woman takes the second drug, misoprostol, which causes the uterus to contract and expel the pregnancy.
The FDA said that the manufacturer of Mifeprex, Danco Laboratories, applied for the updated label as part of a “supplemental new drug application” submitted to the agency in late May. The company proposed that the treatment be used to end a pregnancy through the first 70 days of gestation – that’s 70 days from the first day of the woman’s last menstrual period. Under the original labeling, the treatment was to be used through the first 49 days of gestation.
The agency also approved changes in the doses of the drugs and the dosing regimen. Under the old regimen, a woman would take three Mifeprex tablets on the first day and two misoprostol tablets on the second day. Under the new label, a patient would take one Mifeprex tablet on day one and 4 misoprostol tablets 24 to 48 hours later. Women are advised to return to their health-care providers a week or two after taking Mifeprex, under the revised label. That was two weeks under the old label.
The agency initially approved Mifeprex in September 2000, and women can get it from their health-care providers such as clinics, medical offices and hospitals, and under the supervision of a certified prescriber. It is not available in retail pharmacies, or legally sold over the Internet.
The agency said that cramping and vaginal bleeding are possible side effects of the treatment, and that in some cases surgery will be needed to stop very heavy vaginal bleeding. Other potential side effects, the FDA said, include headache, diarrhea, dizziness and vomiting.
Send questions/comments to the editors.
