Update: FDA strengthens mifepristone labeling

The Food and Drug Administration (FDA) has strengthened the warning information on the labeling for the abortion drug mifepristone. The labeling change is in response to reports of infection, bleeding, and death among women who have taken the drug, according to the FDA.1

Changes to the existing "black box" warning on the product, marketed in the United States as Mifeprex (Danco Laboratories, New York City), reflect heightened information on the risk of serious bacterial infections, sepsis, bleeding, and death that may occur following any termination of pregnancy, including use of Mifeprex. The changes follow reports of such incidents to Danco and to the FDA.

Danco Laboratories has revised the drug’s labeling, medication guide, and patient agreement, and it has alerted providers regarding the new information. (See the resources below for instructions on accessing the revised material.)

According to Danco, about 360,000 women have been treated with Mifeprex in the United States since the drug received FDA approval in 2000. Since its approval, women and doctors nationwide have reported high levels of success and satisfaction with the early abortion option, says Vanessa Cullins, MD, MPH, vice president for medical affairs for the New York City-based Planned Parenthood Federation of America.

"Planned Parenthood supports the updated mifepristone labeling released by the U.S. Food and Drug Administration because it is based on the best scientific information available," she says. "At Planned Parenthood, our No. 1 priority is the health and safety of our patients, and we support responsible safeguards for women’s health."

According to Danco, the rate of reported adverse events (AEs) for Mifeprex is less than 0.2%, and the vast majority are not serious, not emergencies, and are expected, such as ongoing pregnancy and incomplete abortion. Updating the labeling information is a standard procedure for all drugs, states Cynthia Summers, Danco director of marketing and public affairs.

"Our goal is to provide a safe and effective early option for women," she explains. "We are committed to the safety of our patients, and want to ensure that health care providers are aware of the need to watch for any potential side effects, and that patients are informed about when they should call their providers."

Check warning signs

While infection following medical abortion is rare, the new labeling calls for providers to be alert to the possibility of post-procedure infection. Look for any of the following potential indications of infection, and advise patients of such warning signals:

  • sustained fever of 100.4° F or higher;
  • severe abdominal pain;
  • pelvic tenderness in the days after taking Mifeprex and misoprostol (a companion drug used in the medical abortion procedure).

Atypical presentations of serious infection and sepsis, without fever, severe abdominal pain, or pelvic tenderness, but with significant leukocytosis, tachycardia, or hemoconcentration can occur, the new labeling states.

Be watchful for prolonged heavy vaginal bleeding, the new labeling advises. Vaginal bleeding occurs in almost all patients during the mifepristone/misoprostol regimen; women usually experience vaginal bleeding or spotting for an average of nine to 16 days. Up to 8% of women may experience some type of bleeding for 30 days or more.2

Prolonged heavy bleeding, which is characterized as soaking through two thick full-size sanitary pads per hour for two consecutive hours, may be a sign of incomplete abortion or other complications. Prompt medical or surgical intervention may be needed to prevent the development of hypovolemic shock, according to the labeling. Counsel patients to seek immediate medical attention if they experience such prolonged heavy vaginal bleeding following a medical abortion. Providers may treat the excessive bleeding with uterotonics, vasoconstrictor drugs, curettage, administration of saline infusions, and/or blood transfusions.

Providers also should be on the lookout for an undiagnosed ectopic pregnancy in women who are undergoing a medical abortion, since some of the expected symptoms of a medical abortion may be similar to those of a ruptured ectopic pregnancy. The presence of an ectopic pregnancy may be missed even if the patient undergoes ultrasonography prior to being prescribed Mifeprex, the company states.

A small number of ruptured ectopic pregnancies have been reported to Danco during its postmarketing surveillance on Mifeprex; no causal relationship between these events and Mifeprex and misoprostol has been established, the company states.

Use medication guide

Mifeprex providers should give patients copies of the new medication guide to help patients understand the medical abortion process. Women also should be advised to take the medication guides to the emergency department or any other health care provider they may visit for problems. The guide will help those health care providers to understand that the patient is undergoing a termination of pregnancy and help them assess risks associated with that condition.

Help women to understand that mifepristone medical abortion is "extremely safe and extremely effective," says Cullins.

"It, like any other pregnancy-related situation, is not without risks," she adds. "It is much safer than carrying a pregnancy to term, whether or not that pregnancy ends in either vaginal delivery or cesarean section."


1. Food and Drug Administration. FDA to Announce Important Labeling Changes for Mifepristone. Press release. Nov. 15, 2004. Accessed at: www.fda.gov/bbs/topics/news/2004/NEW01134.html.

2. Spitz IM, Bardin CS, Benton L, et al. Early pregnancy termination with mifepristone and misoprostol in the United States. N Eng J Med 1998; 338:1,241-1,247.


  • For more information on Mifeprex, go to its web site, www.earlyoptionpill.com. PDF versions of the label, medication guide, patient agreement, and provider letter are available on the opening page. Medical questions regarding Mifeprex may be directed to its toll-free number, (877) 432-7596.