The following article has been revised to include the updated guidance from the FDA and its disclaimer about the links between deaths and Mifeprex.
According to the Food and Drug Administration (FDA), there have been reports of two-dozen deaths of women associated with the abortion drug Mifeprex since the product was approved in September 2000.
After receiving “reports of serious adverse events in women” taking the pill, the FDA updated its guidance on mifepristone, or Mifeprex, the drug given to women in the first stage of a medical abortion. Women take mifepristone in conjunction with misoprostol to terminate an unborn child up to 70 days since their last menstrual period.
“It is not uncommon for the FDA to receive reports of serious adverse events for prescription drugs after they are approved,” reads the FDA guidance. “The FDA has received reports of serious adverse events in women who took Mifeprex. As of December 31, 2018, there were reports of 24 deaths of women associated with Mifeprex since the product was approved in September 2000, including two cases of ectopic pregnancy resulting in death; and several cases of severe systemic infection (also called sepsis), including some that were fatal.”
“The adverse events cannot with certainty be causally attributed to mifepristone because of concurrent use of other drugs, other medical or surgical treatments, co-existing medical conditions, and information gaps about patient health status and clinical management of the patient,” the FDA notes, linking to a summary report of adverse events (through December 31, 2018).
According to Life News, since 2000, thousands of women have suffered serious complications from Mifeprex. “Between 2000-2012, there were 2740 cases with any adverse event (an average of 228 per year.) In the last five years, there have been 1445 – or an average 289 per year. This includes 273 hospitalisations, 182 cases of blood loss so severe transfusions were needed, and 103 infections,” the pro-life outlet reported in July 2018.
As noted by the site, this number is likely to be higher than the report shows, since not all women who suffer complications notify their abortion provider or disclose the use of the pill to emergency services.
Meanwhile, abortion activists are pushing for easier access to the drug, particularly on college campuses.