FDA requires “safety plan” for RU-486
As of December 2006, there have been eight known deaths associated with RU-486, the medical abortion drug manufactured by Danco. In addition, the FDA records nine life-threatening incidents, 116 blood transfusions, and 232 hospitalizations. In total, more than 1,100 women have had medical problems after using the drug as of that date. Now, LifeNews.com reports, the FDA wants Danco to come up with a “safety plan.”
The Food and Drug Administration has asked the makers of 25 drugs, including the dangerous abortion pill mifepristone (RU 486), to submit safety plans later this year…The drug manufacturers must devise a Risk Evaluation and Mitigation Strategy (REMS) plan and submit it to the agency by September 21…
Jane Axelrad of the FDA’s Center for Drug Evaluation and Research [said] the safety plans help patients and physicians know the dangers of a drug used improperly.
“These safety plans allow patients to have continued access to certain medicines for which there are safety concerns that can be managed through appropriate use,” Axelrad said. “The FDA approved the drugs identified today before the new law was passed, and they will now be brought under the new statutory authority to require and enforce REMS.”
It’s easy to see why patients with certain illnesses might take medications with histories of complications. Risk vs. reward. Lesser of two evils. That kind of thing. But the main reason for choosing RU-486 is money: Medical abortions are cheaper than the surgical kind. Sad that women are willing to risk their lives when the biggest ”evil” most face is the birth of a living child.




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back to top4 Comments to “FDA requires “safety plan” for RU-486”
As always, some of this springs from deliberate ignorance. The drugs used in RU-486 include one which was never intended as an abortifacient–the manufacturer, in fact, recommends the misoprostal NOT be used for abortions.
Misoprostal is designed to treat ulcers.
Chemical abortions may be cheaper than surgical abortions, but I would hazard they’re also used by women who don’t want to go to abortion clinics. The drug has to be taken before seven weeks, however, for it to be effective.
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“Medical abortions are cheaper than the surgical kind.”
That should be “medicinal” rather than “medical”.
One of the big market demographics for this drug is not particularly well suited to following directions reliably.
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Well,
That might be a good idea. I suppose every company should have safety plans for all of their products.
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Isn’t there something at least mildly ironic in having a “safety plan” for a drug that kills by design anyway?
Kind of like using sterile needles to execute condemned criminals…
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