March 31, 2016

Unanswered questions in light of FDA changing its RU-486 protocol

Both Dr. Randall K. O’Bannon, Ph.D., NRL Director of Education & Research, O’Bannon and myself wrote about the decision, which came at the behest of Danco, the U.S. distributor. Reuters paraphrased Abby Long, a spokeswoman for Danco, as saying

The FDA update reflects data from 22 studies including almost 31,000 women that showed the existing information is out of date.

Dr. O’Bannon succinctly summarized the alteration in the two-drug abortion technique known as RU-486.

The FDA, responding to a request by the U.S. distributor of the drug, has modified dosages [more of the cheaper misoprostol , less of the more expensive mifepristone ], changed the administration, reduced the number of visits, expanded the prescriber pool, and extended the time frame where the drugs may be used. Though applauded by the abortion industry, the documentation demonstrating the impact on women’s safety has not been made publicly available.

Let’s think about this for a while.

Obviously the Abortion Industry is ecstatic. It can make more money off the altered dosages and attract women who may be wary about a surgical abortion (not knowing how bloody and excruciating painful these chemical abortions are). More to the point the FDA gave its after-the-fact support for what abortionists had decided to do on their own going back years and years.

But what don’t we know? Here are just a few items.

Danco spokeswoman Long told Reuters it has been “has been used by more than 2.75 million women in the United States since it was approved in 2000,” but (interestingly) “declined to provide sales data for the pill.” We don’t know how many women have died after taking RU-486 or suffered “adverse events.”

Or, more specifically, we don’t know anything more than what we learned five years ago! At that juncture, the FDA reported that the deaths of 14 women were associated with the use of RU-486 and that there had been 2,209 “Adverse Events.” Adverse events is a blanket term that covers everything from the need for blood transfusions to endometritis, pelvic inflammatory disease, and pelvic infections with sepsis (“a serious systemic infection that has spread beyond the reproductive organs,” according to the FDA).

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