Advisory panel to FDA approves five-day emergency contraceptiveJune 18th, 2010 - 11:57 pm ICT by BNO News
WASHINGTON, D.C. (BNO NEWS) – An advisory panel of the U.S. Food and Drug Administration (FDA) gave approval on Thursday to an emergency contraceptive available for use up to five days after intercourse, CNN reported on Friday.
The pill is meant for use for women who have had unprotected sex or for whom another method of contraception, such as a condom, failed. Currently, there are no FDA-approved emergency contraceptive drugs available in the U.S. for more than 72 hours after unprotected sex or failed contraception.
Two phase 3 clinical trials have demonstrated that the new drug, called Ella, is effective and safe. One of the trials was done with women 18 and older in the United States; the other was done in the United States, the United Kingdom, and Ireland with women 16 and older.
Ella, manufactured by HRA Pharma, is a selective progesterone receptor modulator. Progesterone is a hormone key to the pregnancy process. This specific sort of drug has never been approved as an emergency contraceptive.
Pro-life groups have criticized the drug, accusing it of being a form of early abortion. However, a group of 20 women’s health organizations wrote a letter to the panel backing the drug, citing the roughly 3.1 million unintended pregnancies each year in the United States.
“We do not believe technology holds all the answers, but having two types of safe and effective emergency contraception will increase the likelihood that a woman can access a product that works for her situation,” the letter said.
While the FDA does not have an obligation to take the advisory panel’s recommendation, it often does.
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Tags: advisory panel, bno, clinical trials, cnn, contraception, contraceptive drugs, emergency contraception, emergency contraceptive, food and drug, food and drug administration, food and drug administration fda, health organizations, intercourse, life groups, method of contraception, phase 3, progesterone, progesterone receptor, unintended pregnancies, unprotected sex