Panel Recommends Contraceptive Drug

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Panel Recommends Contraceptive Drug

Special Report - June 23, 2010
A Food and Drug Administration (FDA) advisory panel has unanimously voted to recommend that the FDA approve the controversial drug, ulipristal acetate, for sale as an “emergency contraceptive” in the United States. The FDA’s Reproductive Health Drugs Advisory Committee voted 11 to 0 on June 17 in favor of approving the drug, which will potentially be marketed under the name “Ella” and has been dubbed the “5-day morning after pill.”

Proponents describe the drug as an emergency contraceptive that works similar to the “morning-after pill” or Plan B, which can prevent pregnancy up to 72 hours after sexual intercourse and is available without prescription to women age 17 or older. But unlike Plan B, which must be taken within 72 hours of sexual intercourse to work correctly, Ella can be taken within 120 hours (or up to 5 days) of sexual intercourse. Another key difference between the drugs is that Ella is a “selective progesterone receptor modulator” (SPRM), which according to studies, “appears to exert an anti-progesterone contraceptive effect on both the ovary and endometrium, depending on the dose and the time of drug administration during the menstrual cycle.” It mainly works to inhibit or delay ovulation but it can also alter the endometrial lining (or the lining of the uterus), and in some cases prevent implantation. According to the FDA, if it Ella is approved, it would be the first SPRM approved for use as an emergency contraceptive in this country, as well as the “first emergency contraceptive drug indicated for use up to 120 hours after [unprotected intercourse].” The only other SPRM approved for use in the U.S. is the chemical abortion drug mifripristone, or RU-486, which causes the abortion of an unborn child up to 49 days into a pregnancy. For this reason, pro-life groups argue that Ella should not be marketed as an emergency contraceptive but as an abortion drug, because it more closely resembles RU-486.

In a letter to the FDA objecting to the approval of ulipristal acetate (or Ella), the American Association of Pro-Life Obstetricians and Gynecologists (AAPLOG) wrote: “AAPLOG has concluded from publicly available information that ulipristal acetate is an abortifacient of the same type as mifepristone (‘RU-486’) and that its approval as an emergency contraceptive raises serious health and ethical issues. Furthermore, ulipristal’s potential effects on women who used the drug off-label and upon ongoing pregnancies are essentially unexamined and untested. Ulipristal’s ability to destroy established pregnancies, as well as prevent implantation, makes it an embryocidal drug.”

During testimony before the FDA panel on June 17, AAPLOG president Donna Harrison, MD, warned, “In the real world, it is inevitable that women who are already pregnant will unknowingly take ulipristal. In addition, ulipristal’s two percent failure rate means that two out of every 100 women who use this drug will carry a fetus exposed to ulipristal, a drug known to interfere with placental development.” Dr. Harrison told the advisory panel that. “approval of ulipristal will put the FDA in the untenable position of approving a drug which is contraindicated in pregnancy for an indication in which use in pregnancy is inevitable, and for which inadequate safety information is available.”