A new emergency contraceptive under review by the Food and Drug Administration, called Ella, is safe and effective, according to a staff report released Thursday. That determination bodes well for approval of the drug, which is described as twice as effective as existing emergency contraception drug, Plan B. Ella is also effective for up to five days after unprotected sex, while Plan B loses effectiveness after 72 hours.
FDA’s Advisory Committee for Reproductive Health Drugs is expected to meet Thursday to decide whether to recommend approval of the drug.
The report included data from tests of the drug involving nearly 5,000 women in the U.S. and Europe. According to the report’s summary of safety, “No deaths occurred and no unexpected adverse outcomes were observed in the clinical development program. The most common adverse reactions were nausea, headache, dysmenorrhea [painful menstrual periods], abdominal pain, fatigue, and dizziness.”
Although it has only been tested as an emergency contraceptive, and is only proposed to be used for emergency contraception, the drug is chemically similar to the abortion drug, RU-486. That similarity has earned it opposition from conservative groups.