According to Judicial Watch, a controversial drug that was pushed through a federal government approval process during the Clinton administration has killed nearly two dozen women. Records uncovered by Judicial Watch, a transparency advocacy organization, showed that the drug (Mifeprex) produced serious adverse effects in thousands of others. Records show that nearly 100 women who took Mifeprex (RU-486) suffered ectopic pregnancies, while hundreds more needed blood transfusions and hospitalization. The drug was approved in 2000 and is sometimes call the "morning-after pill."
In 2006, Judicial Watch produced a report based on thousands of pages of FDA and National Archives documents. According to a press release, Judicial Watch found that the Clinton administration aggressively thrust the “abortion pill” into the U.S. market despite warnings of its hazards.
A FDA summary table obtained by Judicial Watch shows that between 2000 and 2017, Mifeprex (mifepristone) killed 22 women. Ninety-seven others had ectopic pregnancies, which can cause life-threatening bleeding, and 4,185 reported adverse effects. 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.
Mifeprex was fast-tracked under the “Accelerated Approval of New Drugs for Serious or Life-threatening Illnesses,” which 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. Physicians have warned for years about the dangers posed by Mifeprex and some have called for a ban. Dr. Donna J. Harrison of Berrien Springs, Michigan, warned more than 10 years ago in an article in the New York Times that the feds approved Mifeprex after circumventing 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,” said the release from Judicial Watch. 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. The ACLU sued the Federal Drug Administration in 2017 to expand the availability of Mifeprex, claiming that the drug “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.”
Judicial Watch has made several requests for under the Freedom of Information Act (FOIA) and expects to receive “thousands of pages of individual Adverse Event Reports from the FDA involving Mifeprex…”
The advocacy group asserted that the data from the federal government may not be complete because it includes only cases that have been “reported,” which means that adverse effects or even deaths may not be disclosed to the government. The release noted that 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.”
Danco Laboratories, which is based in the U.S., received approval in 2016 from the FDA for Mifeprex to be used through 70 days of pregnancy rather than the previous 49 days. The FDA approved changes to product labelling that include revisions to the prescribing information, patient medication guide, patient agreement form and prescriber agreement form. Reflecting what Danco called the”most current clinical practices and safety and efficacy data for Mifeprex,” Mifeprex is used in conjunction with misoprostol to induce abortion. The relaxed guidelines permits nurse practitioners, acting without a licensed physician, to administer the abortion.
The Hua Lin Pharmaceutical Company in China, based in Shanghai, was contracted in 2000 to produce the raw compound in Mifeprex for export to the U.S., according to company officials. The company was assisted by the Rockefeller Foundation in winning the production license for Mifeprex, said Gao Ersheng, a research director at the Shanghai Family Planning Commission, according to Reuters. FDA inspected the Hua Lin facility for compliance with U.S. standards.