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Doctors: Safety Regs Needed to Protect Women Using RU 486 Abortion Drug

Posted by ssbg on December 31, 2005

by Steven Ertelt Editor
December 28, 2005

Washington, DC ( — Two doctors have conducted an exhaustive analysis of the FDA’s listing of problems women who have used the abortion drug have reported. They say new safety regulations are needed to protect the health of women who may be adversely affected.The abortion drug has been responsible for the deaths of four California women and caused sometimes severe health problems for more than 600 women.

In addition to the deaths, the FDA reports included 237 cases of hemorrhage that were either life-threatening (42 cases) or extremely serious (168 cases). Some 71 women required blood transfusions. Another 513 of the reports indicated women required surgery to repair damage resulting from the abortion, including nearly half under emergency conditions.

Researchers Margaret Gary, MD, and Donna Harrison, MD, say the 607 adverse effects reported over the last four years also include women who suffered from severe bleeding, infection, unsuccessful abortions, and fetal malformations that appeared after failed abortion attempts.

As a result of their findings, the doctors call for increased research into the allergic and fatal septic reactions associated with mifepristone.

They also urge that ultrasound imaging be performed before use of the drug to rule out ectopic pregnancies and propose that a fetal registry be established to track birth defects in mifepristone survivors.

Finally, incomplete information in many of the adverse event reports prompts Gary and Harrison to speculate on whether the FDA’s Adverse Event Reporting System adequately identifies risks and protects public health.

The doctors’ report also detailed ruptured ectopic pregnancies, a potentially fatal condition requiring emergency surgical intervention. Unusual allergic reactions were also noted, which Gary and Harrison suspect may have resulted directly from the drug’s mechanism of action.

Gary and Harrison’s article is titled “Analysis of Severe Adverse Events Related to the Use of Mifepristone as an Abortifacient,” will appear in the February issue of The Annals of Pharmacotherapy.

The Annals of Pharmacotherapy is a leading peer-reviewed, international pharmacotherapy journal for physicians, pharmacists, and other healthcare professionals.

Related web sites:
The Annals of Pharmacotherapy –

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