FDA Approves Controversial Morning After Pill Ella

The Food and Drug Administration (FDA) has approved a new type of morning-after contraceptive pill called Ella in the United States, the drug already is approved in Europe and sold there as EllaOne. Ella has been widely criticized by antiabortion groups as being an “abortion pill” instead of a method of emergency contraception.

The FDA said it gave approval for the for Ella following two phase III clinical trials that “offered persuasive data on efficacy and adequate data on safety.” One was a prospective, multi-center, open-label, single-arm trial conducted in the USA; the other was a randomized, multi-center, single-blind comparator-controlled trial conducted in the USA, UK and Ireland.

Women who have unprotected sex have approximately a 1 in 20 chance of getting pregnant. Those who take Plan B within three days cut that risk to about 1 in 40, while those who take Ella would cut that chance to approximately 1 in 50, researcher noted. Research also found that Ella is less effective in overweight women.

Ela is the first emergency contraceptive to gain FDA approval since a five-year battle under the George W. Bush presidency.

The FDA says clinical trials found the medication is safe and effective, however cautioned it is not meant for routine use.

The most frequently noted adverse side effects in the Ella clinical trials were headache, nausea, abdominal pain, dysmenorrhea, fatigue, and dizziness. FDA-approved levonorgestrel emergency contraceptives have similar adverse effects, the agency stated.