An emergency contraceptive pill that prevents pregnancy even till five days after unprotected sex got US Food And Drug Administration approval on Saturday.
This paves the way for Ulipristal Acetate, already approved in 22 countries in Europe, to get marketing approval in India. The drug is manufactured by France-based HRA Pharamaceuticals and sold as ellaOne in Europe and ella in the US.
Ella Ulipristal acetate is more effective than levonorgestrel, the pill currently available in India, which stops pregnancy up to 72 hours after sex. While levonorgestrel — sold under the brandnames i-pill and Unwanted 72 — slowly loses efficacy after 24 hours, ella works just as well on the fifth day after sex.
The sooner you take Levonorgestrel, the more effective it is in stopping pregnancy. It is 95 per cent effective within 24 hours of unprotected sex.
The emergency contraceptive market is worth R100 crore, growing almost 25 per cent since the pill went over-the-counter in 2007.
Studies involving 4,500 women in the US show ella causes mild side effects like headache, nausea, cramps, fatigue, dizziness, the FDA said. It didn’t seem to cause any problems for the few women who became pregnant after taking it but was less effective in the obese.
Morning-after pills, however, shouldn’t be used as contraceptives.
“That’s because it can cause frequent fluctuation in hormonal levels. Using it two to three times a year may not cause a problem, but if you need it more than that, contraception is better,” said Dr Sunita Mittal, professor and head of the department of gynaecology and obstetrics, AIIMS.