Blog Post

FDA Expands Access to Abortion Pill

ru486 pillCommentary by Susan Brinkmann, OCDS

In spite of its long record of debilitating side effects for women and deadly consequences for the unborn, the FDA has relaxed guidelines for the use of the abortion drug, RU486, allowing it to be used further into pregnancy and with fewer doctor visits.

The New York Times is reporting on the announcement from the FDA which now allows the drug to be dispensed according to what has become a common “off label” practice – that of reducing the dosage from 600 to 200 milligrams, allowing women to take it up to 10 weeks instead of seven, and cutting the number of required doctor visits from three to two.

RU 486 is typically dispensed in the form of two pills. The first, mifepristone, deprives the growing unborn child of food and water. The second, misoprostol, causes contractions allowing women to give birth to the dead baby. The drug, which causes common side effects such as cramping and bleeding, is said to be 95 percent effective if used within the first 50 days of pregnancy.

However, much more serious side effects have occurred, mostly due to “off label” use, which is why many believe this new decision could be motivated more by politics than science – especially because the request to ease the guidelines didn't come from the medical community but from the U.S. distributor of the drug.

“Some abortion opponents charged that the new regimen was politically motivated,” the Times reports. “The FDA said its actions were based strictly on medical science.”

What kind of “medical science” rewards doctors who prescribed this potentially dangerous drug to women “off label” – meaning they did not follow the FDA’s much more stringent guidelines for using it? Obviously, at some point since its introduction in 2000, doctors decided to experiment with women’s health by using the drug in unapproved ways. Instead of holding these physicians accountable, they are now "approving" their "unapproved" practice!

Keep in mind, this "off-label" use was not without consequence. As National Right to Life points out, the drug is linked to at least 14 deaths and thousands of women who suffered serious adverse side effects such as heavy bleeding, bacterial infection, and a malformed baby if the pregnancy does not end.

For example, the latter effect is what ended the life of 18 year-old Holly Patterson in 2003 whose parents didn’t even know she took the drug until four hours before her death from septic shock. The Planned Parenthood where she received the drug dispensed it “off label”.

She wasn’t the only California woman to die from the same “off label” use of the abortion pill. In fact, it was only after four other California women died in one week after taking the drug "off label" that the Planned Parenthood dispensing the drugs decided to return to following FDA guidelines.

And these new guidelines are now safe for women? Not exactly.

“Though applauded by the abortion industry, the documentation demonstrating the impact on women’s safety has not been made publicly available,” reports Dr. Randall K. O’Bannon, NRL Director of Education & Research.

“While it may be claimed that these side effects are supposed to be reduced with the new protocol, chemical abortions simply do not occur without significant bleeding, cramping, etc. That these side effects are similar to signs of ruptured ectopic pregnancy, serious infection, or may be the prelude to significant hemorrhage that could be missed by patients or even doctors expecting these as part of any chemical abortion would still appear to be a problem under any protocol.”

He concludes: “In the end, it is obvious that the FDA’s new protocol serves only the interests of the abortion industry by expanding their base of potential customers, increasing their profit margin, and reducing the level of staff and amount of resources they have to devote to the patient. It is clear whose interests the FDA is serving. It isn’t the women, and it isn’t the babies.”

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