Called ‘ella,’ drug delays ovulation, but opponents say it’s another abortion pill
Bloomsberg Business Week
Executive Health August 14, 2010, 07:32 EST
FRIDAY, Aug. 13 (HealthDay News) — The U.S. Food and Drug Administration on Friday approved the ella (ulipristal acetate) emergency contraceptive pill, which prevents pregnancy if taken within five days of unprotected intercourse or contraceptive failure.
The prescription-only drug, which has been available in Europe since May 2009, is a progesterone agonist/antagonist that is thought to work by inhibiting or delaying ovulation, according to a statement from the FDA.
Approval comes after an agency advisory committee unanimously supported ella’s approval in a decision announced in June.
“The safety and efficacy of ella were demonstrated in two phase [3] clinical trials,” the FDA noted. “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.”
The agency said that side effects noted with ella are similar to those of other emergency contraceptives already approved and include headache, abdominal pain, nausea, pain/discomfort during menstruation (dysmenorrhea), fatigue and dizziness. The drug, manufactured by Paris-based Laboratoire HRA Pharma, is not recommended for women who are pregnant or think they might be pregnant or for women who are breast-feeding.
Planned Parenthood was quick to commend the FDA’s decision.
Follow Us!