FDA "Aggressively Investigating" Holly Patterson’s Abortion Drug Death
by Steven Ertelt
November 3, 2003
Washington, DC (LifeNews.com) — A spokesman for the FDA on Monday said that the agency is "aggressively investigating the death" of Holly Patterson from the mifepristone (RU 486) abortion drug.
Only days after obtaining the abortion drugs from Planned Parenthood, California teenager Holly Patterson was taken to a local medical facility complaining of severe pain. She died soon after.
On Friday 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.
Pro-life groups suspect off-label use played a part in the death and they are asking Congress and the FDA to tighten rules for its use or remove it from distribution entirely.
Though the FDA has only approved the abortion drug to be used up to seven weeks into the pregnant, Planned Parenthood distributes it to women who are as many as nine weeks pregnant.
Women are 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.
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 pro-abortion group 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. Pro-life groups say Planned Parenthood may be sacrificing women’s health in the process and that there can be complications during the home expulsion of the dead baby.
The 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.
Patterson met the FDA guidelines for how long she was pregnant, but she was advised to take the abortion drug in a different manner from FDA regulations.
According to a report from the Washington Post, though the FDA says it doesn’t condone the misuse of the abortion drug, it says state agencies are responsible for overseeing any derivations from the guidelines.
Pro-life groups don’t like the misuse of the abortion pill.
"The FDA put those restrictions on how it should be used because they concluded that was the safest way for women to use it," said Wendy Wright, senior policy director for Concerned Women for America. "The fact that it’s being used differently is very worrisome."
Wright’s group is one of several that have filed a citizen’s petition calling on the FDA to pull the drug from the market.
Monty Patterson, Holly’s father, agrees that the FDA should re-examine the safety of the abortion pill.
"I am not putting out a pro-choice or pro-life stand," he explained. "We need to know that drugs are safe and, if they are not safe, do something about it."
Patterson said he and his wife feel an obligation to inform other young women of the "grave dangers" of the drug.
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 Post. "The opposition here is political and not medical, because the medical community is comfortable with the way the drug is being administered."
In fact, Planned Parenthood says the FDA protocols are inconsistent with the latest medical research on the abortion drug and it admits Patterson’s instructions on taking RU 486 were different from the FDA guidelines.
Though dangerous, the drug remains popular.
Danco Laboratories, the manufacturer and distributor of mifepristone, said sales of the drug increased by 43 percent in fiscal 2003 over the year before. In Europe, the drug is responsible for 15 to 30 percent of all abortions, though that level hasn’t been reached here.