Sunday, August 22, 2010

Moral of the story: A new 5 day emergency contraceptive drug is now on the market.  Previously the only option was a 2 day EC.

Source: AMA Morning Rounds 8/16/10


FDA approves new five-day emergency contraceptive.

NBC Nightly News (8/13, story 8, 0:15, Curry) reported, "Today, federal health officials approved a new type of morning after contraceptive that reduces the chance of pregnancy for five days. That's two days longer than the emergency contraception known as Plan B. The new pill is called Ella and it will be available by prescription only."
        The AP (8/14, Perrone) reported that the FDA on Friday approved a new type of morning-after contraceptive, Ella from HRA Pharma, a prescription-only birth control option that reduces the chance of pregnancy up to five days after sex. Ella "uses the hormone progesterone to delay ovulation, a key step in the fertilization process. Despite this, the drug has drawn criticism from anti-abortion groups who say it is closer to an abortion pill than an emergency contraception pill. Groups including the Family Research Council argue the drug is chemically similar to the abortion drug mifeprestone, which can be taken to end a pregnancy up to 50 days into the gestation period."
        The Los Angeles Times (8/14, Maugh II) "Booster Shots" blog said that the drug, "known generically as ulipristal acetate, is thought to inhibit or delay ovulation by interfering with the effects of the female hormone progesterone, which stimulates ovulation. ... Women with a known or suspected pregnancy or who are breastfeeding should not use the drug."
        The Washington Post (8/14, Stein) said that Ella "can cut the chances of becoming pregnant by about two-thirds for at least 120 hours after a contraceptive failure or unprotected sex, studies have shown." Supporters and opponents both said the FDA's decision "marked the clearest evidence of a shift in the influence of political ideology at the FDA. ... If the history of Plan B is any indication, Ella's approval is likely to mark the beginning of many years of political and regulatory battles over the drug."
        The New York Times (8/14, A1, Harris) reported on its front page that "some advocates said Friday that the agency's relatively rapid adoption of its scientists' advice meant that its traditional separation from political considerations had returned. 'It's really important the FDA made a decision that's based on the scientific evidence and not on the political controversy,' said Diana Zuckerman, president of the National Research Center for Women and Families. But Wendy Wright, president of Concerned Women for America, which opposes abortion, said that political considerations were still at work inside the agency."
        The Wall Street Journal (8/14, Mathews, Dooren) noted that the label says ulipristal likely works by inhibiting or delaying ovulation, but its efficacy also may be partly due to an effect of altering the lining of the uterus in a way that affects implantation.
        Bloomberg News (8/14, Waters, Peterson) noted, "Side effects among the 2,600 women who took part in studies included nausea, headache, abdominal pain and dizziness. Ella shouldn't be used when a woman is pregnant or suspects she may be, Watson said in the statement." In addition, "women who become pregnant or complain of lower abdominal pain after taking the drug should be examined for the possibility that an egg has become fertilized and lodged outside the uterus, the company said."MedPage Today (8/13, Gever) and WebMD (8/13, DeNoon) also covered the story.

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