Pro-life groups say the Food and Drug Administration‘s new warning label on the “morning after” abortion pill is a small step in the right direction but not enough.
“Women’s lives are at stake, while the FDA is fretting over political correctness,” said Kurt Entsminger, president of Care Net, a group that supports a network of 800 crisis pregnancy centers in the U.S. and Canada.
The pill, RU-486, was implicated in the death of 18-year-old Holly Patterson of California last year, who died of septic shock caused by inflammation of the uterus.
Danco Laboratories’ product, Mifeprex, now requires an expanded warning, informing consumers of rare, but potentially life-threatening complications that can follow any abortion.
But that is not enough for Entsminger and other opponents, who have urged Congress to pass the RU-486 Suspension and Review Act, introduced in the House and Senate.
The measure would remove the drug from the market and require review of the FDA’s approval process for the drug.
“If consumers are suffering and even dying, additional small print on a piece of paper is not the answer,” Entsminger said.
Concerned Women for America called RU-486 “a dangerous drug that deserves to be pulled off the market immediately.”
Entsminger contends that in addition to hundreds of adverse effects reported to the FDA about the drug, some abortion providers are violating agency guidelines.
Some will administer RU-486 at up to nine weeks of gestation, instead of the seven-week limit set by the FDA, said Entsminger. Some also are allowing women to take the second drug, misoprostol, at home.
Misoprostol actually terminates the pregnancy when followed by RU-486, which blocks a pregnancy-sustaining hormone called progesterone.
“The FDA must answer as to why these violations are occurring, and an additional review must take place as to whether or not the drug is truly safe for women,” he said.
Entsminger points out that despite assurances by RU-486′s manufacturer that the drug is safe, the FDA has received 676 reports of negative side effects, including three deaths, 17 ectopic pregnancies, 72 cases of severe blood loss requiring transfusion and seven cases of serious infection.
Common side effects include painful contractions, nausea, vomiting, diarrhea, pelvic pain and spasms, dizziness and headaches and the emotional trauma of potentially seeing the fetal remains.
“The FDA’s casual approach to a potentially deadly drug is an affront to women,” Entsminger said. “We urge them to immediately suspend the drug and require a thorough review of its safety and long-term impact on women’s health and future fertility.”
In defense of its product, Danco Laboratories has stated that 200,000 American women and more than 1 million women worldwide have used the pill since it was invented in France in the 1980s.