On Friday, August 13th, 2010, the U.S. Food and Drug Administration (FDA) Advisory Committee for Reproductive Health Drugs approved the sale and use of ulipristal acetate (UPA) or “ella,” the brand name for a new form of emergency contraception that will provide women with more options to prevent unplanned pregnancies.
The mechanism of UPA is to prevent or delay ovulation and therefore prevent pregnancy. Pregnancy, “according to widely accepted medical definitions,” noted the FDA’s statement announcing its decision, “occurs when a fertilized egg implants into the lining of the woman’s uterus.”
According to the panel of medical experts who weighed all of the scientific information, ella has been proven to safely and effectively prevent pregnancy up to five days after unprotected intercourse with no decline in efficacy during that time period.
Data show it to be more effective at delaying ovulation than other methods of emergency contraception during the time when women have the highest chance of getting pregnant, may experience contraceptive failure, and are most likely to be having sex. Similar to other methods of emergency contraception, ella prevents pregnancy; it is not the same thing as mifepristone or the ‘abortion pill.’ And, according to FDA, “It is not intended for routine use as a contraceptive.”
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“This promising new emergency contraception is already being used in Europe,” noted Planned Parenthood Federation of America in a statement applauding the FDA decision.
Bridging the gap in access to methods that can prevent unintended pregnancy is an important goal in the United States. Nearly half of all pregnancies among American women are unintended, according to the Guttmacher Institute, and four in 10 of these unwanted pregnancies are terminated by abortion. Forty percent of pregnancies among white women, 69 percent among blacks and 54 percent among Hispanics are unintended.
The FDA committee responsible for reviewing data on ella voted unanimously for its approval, citing “compelling data on efficacy and sufficient information on safety for the proposed indication of emergency contraception.” According to FDA:
The safety and efficacy of ella were demonstrated in two Phase III clinical trials. One study was a prospective, multi-center, open-label, single-arm trial conducted in the United States; the other was a randomized, multi-center, single-blind comparator-controlled trial conducted in the United States, United Kingdom and Ireland.
Side effects most frequently observed with ella in the clinical trials include: headache, nausea, abdominal pain, pain/discomfort during menstruation (dysmenorrhea), fatigue, and dizziness. The profile of side effects for ella is similar to that of FDA-approved levonorgestrel emergency contraceptives.
According to the product’s labeling, continued the FDA statement, women with known or suspected pregnancy and women who are breastfeeding should not use ella.
A patient package insert also will be provided to ensure that women are fully informed of the benefits and risks involved in the use of ella.
Women’s health advocates applauded the decision.
“Every woman deserves every option available to prevent an unplanned pregnancy, and there are many reasons why a woman may face the risk of unintended pregnancy — from failure or improper use of birth control, to sexual assault,” said Cecile Richards, president of Planned Parenthood Federation of America. “The FDA’s approval of this new form of emergency contraception gives women one more option.”
“Approval of ella is another indication that the FDA is committed to restoring scientific integrity in its decisions,” stated Kirsten Moore, President of the Reproductive Health Technologies Project. “We hope the agency will continue to uphold these values and remove the unwarranted age restriction on Plan B One-Step and Next Choice,” she continued, two methods to which over-the-counter access has been limited to women ages 17 and older, despite lack of evidence suggesting barriers to access are medically necessary.