RU-486: Individual Safety Reports

When the Food and Drug Administration (FDA) approved the abortion pill RU-486 in 2000, it was anyone's guess how it would impact women.

Four years later, we can see what it has done to women.

Adverse Events Reports filed by doctors, the drug's distributor, and women themselves tell the stories. Though most are in clinical terms and the list is not complete (not every event gets reported), they paint a picture of woman after woman carried into hospital emergency rooms after taking this killer drug.

While the purpose of the RU-486 drug regimen is to kill unborn babies, these reports show they are not the only victims.

These documents were produced for Concerned Women for America (CWA) by the FDA in response to a lawful request for records under the provisions of 5 U.S.C. § 552, the Freedom of Information Act (FOIA). The FDA ensured the medical privacy of the women reporting adverse effects from RU-486 by exercising Exemption 6 of the FOIA and redacting personal identifying medical information. This allows the public to understand the dangers of the drug while protecting the identities and privacy of the women who were adversely effected.

The initial release of documents was obtained through a lawsuit filed by Judicial Watch. This second release covers reports filed up to October 31, 2004.

"Judicial Watch is pleased to partner with CWA in our ongoing effort to obtain publicly available government documents. These new documents are an important contribution to the debate on the FDA's assertions that RU-486 is a 'safe and effective' abortion drug," stated Judicial Watch President Tom Fitton.

Judicial Watch's Open Records Project helps conservatives obtain government records about issues important to our movement, such as the protection of unborn life.

Complications from taking RU-486 can be reported through MedWatch, the FDA Safety Information and Adverse Event Reporting Program, found at: https://www.accessdata.fda.gov/scripts/medwatch/