From Judicial Watch, Inc. – a 501(c)3 – August 1, 2018 – A controversial abortion drug rushed through the government’s approval process by the Clinton administration has killed nearly two dozen women and produced serious adverse effects in thousands of others, according to records obtained by Judicial Watch.
Nearly 100 women who took the drug (Mifeprex) had ectopic pregnancies, the records show, and hundreds of others required blood transfusions and hospitalization. Judicial Watch has investigated the government’s handling of Mifeprex, also known as RU-486, since the Clinton administration aggressively shoved the abortion pill through the Food and Drug Administration’s (FDA) approval process in an effort to appease radical pro-abortion activists.
Back in 2006 Judicial Watch published a special report based on thousands of pages of FDA and National Archives documents showing the Clinton administration’s aggressive drive to thrust the abortion pill to the market in the United States despite warnings of its hazards.
Judicial Watch uncovered that the abortion pill was fast-tracked under the “Accelerated Approval of New Drugs for Serious or Life-threatening Illnesses,” a measure that was adopted for use in rare cases to encourage the manufacture and importation of drugs designed to treat life-threatening diseases such as cancer or heart disease. Over the years physicians have warned of Mifeprex’s dangers and some have called for banning it. In a piece published by a mainstream newspaper more than a decade ago, an obstetrician warns that Mifeprex is deadly and explains that it obtained government approval because five standard procedural and scientific requirements to prove safety and effectiveness were circumvented to get it onto the market quickly.
In 2016 the FDA caved in to calls from liberals to make Mifeprex easier and cheaper to obtain and last year a powerful leftist group sued the federal government to make the drug more widely available. The change by the government two years ago increased the use of Mifeprex from 49 days of gestation to 70, slashed the recommended dose and cut the number of doctor visits.
To support the expansion of the drug’s availability, the civil rights group suing the FDA cites the agency’s public assessment of Mifeprex, saying that the abortion pill “has been increasingly used as its efficacy and safety have become well-established by both research and experience, and serious complications have proven to be extremely rare.” The records obtained from Judicial Watch tell a different story.
In the coming months Judicial Watch expects to receive thousands of pages of individual Adverse Event Reports from the FDA involving Mifeprex, but the initial summary figures provided by the agency this month under the Freedom of Information Act (FOIA) are disturbing enough. Once the government furnishes all the files, doctors from a coalition of pro-life groups collaborating with Judicial Watch will dissect the individual reports to supply precise medical assessments of the abortion drug’s dangers.
Keeping with its mission of educating the public, Judicial Watch will issue reports and articles on the findings. The data may not tell the whole story because the government only includes cases that have been “reported,” acknowledging that some adverse effects or even deaths may not be disclosed to the government. In fact, a congressional audit published earlier this year on the FDA’s monitoring of Mifeprex acknowledges that “adverse events may be underreported and that the FDA may only be aware of a fraction of them.”
The FDA summary table recently obtained by Judicial Watch shows that between 2000, when the agency approved Mifeprex, and 2017, the drug killed 22 women. Ninety-seven others had ectopic pregnancies, which can cause life-threatening bleeding, and 4,185 reported adverse effects from using the drug. More than 1,000 women were hospitalized after taking the abortion pill, 598 required blood transfusions and 411 suffered infections, some requiring hospitalization for two to three days.
