Emergency contraceptives pills or birth control pills are type of drugs that are designed to prevent unwanted pregnancies. In past FDA has approved two emergency contraception pills for prescription use – Preven (approved in 1998) and Plan B (approved in 1999). Plan B is the most widely used emergency contraceptive pill and is approved to be sold over the counter. Now after a decade another Emergency contraceptive pill was reviewed and endorsed by FDA named ellaOne.
EllaOne was originally developed by the government organization – National Institute of Child Health and Human Development and manufactured by HRA Pharma, a small French drug company. The drug has already been approved in Europe for sale in 2009.
Results of ellaOne clinical study
The study was published in the Journal of the American College of Obstetricians and Gynecologists. Researchers examined nearly 1,700 women aged 16 to 36 who received emergency contraception within three to five days of having unprotected sex. Half of the women received Plan B and the other half received ellaOne. Women who took ellaOne had 1.8% chance of becoming pregnant, while women who took Plan B had a 2.6% chance. This research was paid for by the makers of ellaOne and HRA Pharma, which helped design the study.
Side effects of EllaOne
The most frequently reported side effect from both drugs was a headache.
During the FDA meeting anti abortion and abortion rights advocates raised the questions about the pros and...
cons of the pill. Donna Harrison, president of the American Association of Pro-Life Obstetricians and Gynecologists said ellaOne kills embryos, just like the abortion pill. It prevents the fertilized egg, the embryo, from implanting in the uterus. And if the embryo has already implanted, it will destroy the embryo.”
However, Paul Fine, medical director of Planned Parenthood of Houston, shed light on the need of the drug in US. He said that Emergency contraception is a woman’s last chance to prevent an unintended pregnancy. And half of all pregnancies in the U.S. are unintended.
After extensive discussion, the panel voted that FDA should approve the drug.
Considering the clinical studies of ellaOne that showed better results than Plan B with similar side effects, it looks like a viable option. Also ellaOne could help prevent pregnancy if taken as late as five days after unprotected sex, whereas Plan B works only if taken within 3 days of unprotected pregnancy.