MAR 31, 2016 06:53 AM PDT

FDA Says Abortion Pill Can be Used Later in Pregnancy

WRITTEN BY: Xuan Pham
Medical abortion pill can now be taken later in pregnancy at lower doses

The Food and Drug Administration (FDA) yesterday updated its guidelines for the prescription and use of Mifeprex, making it easier and cheaper for women to obtain the abortion medication. Specifically, the revision lowers the dosage of the pill, which allows it to be taken 70 days into pregnancy instead of 49 days as recommended previously.
 
Manufactured by Danco Laboratories, Mifeprex is the brand name for mifepristone. This drug works by blocking the progesterone hormone receptors and, in combination with the drug misoprostol, terminates pregnancy. It was developed in 1980 but did not arrive in US markets until 2000 with FDA approval.
 
"After reviewing the supplemental application (from the drug manufacturer), the agency determined that Mifeprex is safe and effective when used to terminate a pregnancy in accordance with the revised labeling," said the FDA.
 
With the new guidelines, the recommended dosage is reduced from 600 milligrams to 200 milligrams. This recommendation was supported by data from 22 studies that included nearly 31,000 women, showing that a one third dose of the previous old label was similarly effective in terminating pregnancy. With the reduced dosage, women can also reduce the number of doctor visits, from three to now two. Moreover, mifepristone use during pregnancy was extended from seven weeks to 10 weeks, giving women considerably more time to take the pill.
 
 

While easing on the access to the abortion pill, the FDA guidelines still requires medical oversight for use of this drug. "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," said Anna Paprocki, staff attorney of Americans United for Life. Under the revised label, women are now advised to follow-up between seven and fourteen days.
 
The decision will affect many American women, especially those living in Texas, North Dakota, and Ohio, as these states strictly adhere to the old federal label standards. These states also legally require the drug to be administered by a licensed clinician, rather than a nurse or a physician assistant.
 
The new guidelines renewed contentions between abortion rights activists and pro-life groups.
 
“It appears this has been done for the convenience and the profitability of the abortion industry,” said Randall O’Bannon, the director of education and research for the National Right to Life Committee.
 
But according to Raegan McDonald-Mosley, Planned Parenthood’s chief medical officer, the new label “represents a significant step forward for science, for women and for health care providers who want to give our patients the highest quality care."
 
Moreover, Vicki Sapora, president and chief executive of the National Abortion Federation, pointed that the new change “has the potential of opening medical abortion care in more rural areas because it does not have to be given by a surgical abortion provider.”

Additional sources: CNN, NY Times
About the Author
  • I am a human geneticist, passionate about telling stories to make science more engaging and approachable. Find more of my writing at the Hopkins BioMedical Odyssey blog and at TheGeneTwist.com.
You May Also Like
MAY 11, 2018
Cardiology
MAY 11, 2018
Gene Therapy to Reduce Risk of Cardiac Arrhythmia
During recovery from a heart attack, the danger is far from over. In a new study from scientists at the University of Bonn and an international team of col...
MAY 15, 2018
Cardiology
MAY 15, 2018
Depression Diagnosis: Serious Concern for Coronary Artery Disease Patients
A new study spearheaded by a long-time cardiology physician assistant (PA) provides evidence for the importance of proactive depression screening for coron...
MAY 23, 2018
Technology
MAY 23, 2018
Building Block Medical Test Is Reusable
MIT's Little Devices Lab has created a more affordable solution called Ampli blocks that consists of modular diagnostic kits, which can be re-oriented and reused....
MAY 29, 2018
Microbiology
MAY 29, 2018
Environmental Factors Drive Belly Fat Buildup
Abdominal fat is a major risk factor for disease. New work could help find those at risk for increased belly fat, and help reverse that trend....
JUN 07, 2018
Genetics & Genomics
JUN 07, 2018
Easily Identifying Pregnancies at Risk for Premature Birth
Premature birth affects almost ten percent of pregnancies and is the leading cause of infant mortality in the US....
JUL 01, 2018
Videos
JUL 01, 2018
Growing Patient Cells on a Chip for Personalized Drug Screens
This work could help eliminate animal models, and tailor medicine to the patient....
Loading Comments...