FDA Official Dismisses Concerns About Off-Label Use of Abortion Drug
by Steven Ertelt
November 22, 2004
Washington, DC (LifeNews.com) — Planned Parenthood and other abortion businesses that dispense the dangerous abortion drug RU 486 have come under fire for failing to follow protocol from the Food and Drug Administration regarding usage of the abortion pill.
However, despite issuing a revised warning label showing significant risks, one leading FDA official is dismissing concerns that women are being given the abortion drug without following FDA suggested guidelines.
After California teenager Holly Patterson died from an infection brought on by the RU 486 abortion drug, it was suggested that off-label use played a part in the death.
Though the FDA has only approved the abortion drug to be used up to seven weeks into the pregnancy, Planned Parenthood distributes it to women who are as many as nine weeks pregnant.
Women are also given different dosages of the drug than what was approved under the FDA protocol. They also take the second pill at home and often vaginally rather than at the abortion facility and orally as the federal agency suggests.
Yet, those violations don’t appear to concern Steven Galson, acting director of the FDA’s Center for Drug Evaluation and Research.
"We are very interested in this issue and have looked carefully at it," Galson told the Contra Costa Times newspaper. "At this point, we have no information to make us think the off-label use is related to adverse events."
That response concerns Gene Rudd, MD, an obstetrician-gynecologist and the associate director of the Christian Medical Association.
"It’s particularly disturbing to hear reports that some abortion clinics have been ignoring even the FDA’s minimal safeguards, and that women are not receiving adequate monitoring by physicians," Dr. Rudd said.
A county coroner’s office report confirmed that the use of RU 486 resulted in an incomplete abortion that led to uterine infection and caused Holly’s death.
Planned Parenthood says the abortion drug can be given in lower doses and vaginally to prevent side effects and cause less nausea. However, the lower dose may have been responsible for the incomplete abortion.
The abortion business says women should be able to take the second part of the two-part abortion drug at home, rather than at the abortion facility, to be able to have more privacy.
Yet, Alan Guttmacher Institute, Planned Parenthood’s own research facility, says the U.S. is alone in allowing women to take the abortion drug at home. In Europe, where RU 486 has been approved for 10 years, taking the abortion drug at home "remains rare" according to an AGI official.
Dr. Rudd says taking the abortion drug at home subjects women to greater medical risk.
"The symptoms that may indicate serious and life-threatening problems after taking this drug are difficult even for some physicians to recognize, much less for a patient to have to figure out at home," Rudd explained.
But, a Planned Parenthood representative says there is no problem with deviating from the FDA’s regulations on the abortion drug.
"The FDA recognizes that once they approve a drug, the science advances and doctors use it based on scientific evidence," Vanessa Cullen, vice president for medical affairs for the Planned Parenthood Federation of America, told the Washington Post last November. "The opposition here is political and not medical, because the medical community is comfortable with the way the drug is being administered."
Rudd also criticizes the FDA for initially failing to include having an ultrasound in its guidelines yet issuing a warning last week asking abortion practitioners to be on the lookout for ectopic pregnancies.
The drug can cause fatalities if used by women with rare tubal pregnancies.
"The FDA belatedly emphasizes that ‘health care providers should be vigilant for patients with undiagnosed ectopic pregnancies as this condition may be missed by physical examination and ultrasound,’" Dr. Rudd explained.
"The truth is that ultrasound does actually help diagnose ectopic pregnancies in many cases, yet the agency decided to drop its initial requirements for ultrasound after politicians knocked on their door," Rudd added.
Related web sites:
Christian Medical Association – https://www.cmdahome.org