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August 17, 2010

FDA Approves of New Emergency Contraceptive Pill

The U.S Food and Drug Administration have approved of ella, a new one-dose emergency contraceptive that works longer than the current leading drug on the market.  In June this year, the FDA unanimously voted that the use of ella provided convincing data and sufficient information on its safety.  ella was approved last year in Europe under the name ellaOne and is currently used in 22 countries.

The FDA approved ella as a prescription-only birth control option.  This ruling allows for U.S sales of the drug.  Ella from HRA Pharma is to be marketed as an emergency contraceptive that can be taken within 5 days of unprotected sex or contraceptive failure.  The current emergency contraceptive drug ‘Plan B’ is approved for use up to 3 days after unprotected intercourse.

In a trial between Plan B and ella, women randomly received one of the two pills within three to five days of having unprotected sex.   Women who took ella had a 1.8 percent chance of becoming pregnant.  Women who took plan B had a 2.6 percent chance.

Consequently, Plan B is currently available without a prescription for those 17 and older where as ella will require a doctor’s prescription.  HRA Pharma did not request an over-the-counter position for ella.

There is some concern about women becoming confused by the use of ella. Although ella prevents ovulation for as long as 5 days after sex, some women may believe that once taking ella, it can protect them against pregnancy from any additional acts of unprotected sex for 5 days.  This is not true as sperm from additional sex can outlive the initial sperm past the 5 day window.  In addition, the FDA is concerned about the obesity rates in the US and ella’s effect on overweight and obese women.   Ella seems to be less effective in obese women.

Ella works differently than Plan B.  Though both emergency contraceptives contain hormones that prevent ovulation, ella also contains ulipristal, a non-hormonal drug that blocks the effects of hormones necessary for conception.  Ella belongs to the same class as a drug called mifepristone – a drug that is used as a part of a treatment that induces abortion. This calls for criticism from pro-life groups who believe that ella is closer to an abortion pill than an emergency contraceptive pill.   However, ella is used at lower doses that prevent conception and should not cause abortion.  It is still unknown whether or not ella will affect an existing pregnancy, or if ella might increase the rate of spontaneous miscarriage in the few women who become pregnant despite using ella.

The FDA reviewers reported no life-threatening medical side effects with ella. The most common side effects were mild and included headache, nausea, and abdominal pain.

Birth Control Buzz is a service company that provides birth control prices, types of birth control(prescription required), health administrative services, and birth control statistics predominantly to US patients seeking to purchase pharmaceuticals on-line. For more information, call 1-866-868-8850 or visit http://www.birthcontrolbuzz.com/.

July 2, 2010

New Emergency Contraceptive – EllaOne

A new contraceptive pill has been discovered. The EllaOne offers what has never been available before. It can be used up to five days after unprotected sex and still reduce the chances of pregnancy significantly. Up until now Plan B was the most widely used emergency contraceptive in the market. However, EllaOne has made its mark and is in great demand.

The EllaOne is currently only sold in Europe. Talks about it coming to the United States are underway. The FDA has not approved an emergency contraceptive in years now and it is not yet known if they will approve EllaOne or not.

The emergency contraceptive that is commonly used in the United States is Plan B. Plan B can only be used up to three days after unprotected sex and is also not as effective as the EllaOne. In a recent study, it was found that 1.8% of women who took EllaOne became pregnant, and 2.6% of women who took Plan B resulted in pregnancy. To some people this may not look like a large difference. It is, however, important to acknowledge that a large majority of pregnancies are not intended to happen. Women who find themselves in this position, especially if for the first time, are unsure of what to do next or are even in denial. Having a morning after pill that offers up to five days allows for greater prevention of unwanted pregnancies. This in no ways means that you should wait for longer than need be. It is still best to take the necessary precautions when having sex and use birth control methods, if pregnancy is not wanted.

Furthermore, the EllaOne has proven to be a very controversial issue. Many people do not want this drug to be allowed into the United States. Pro-life groups, especially, are strongly against this pill. “It kills embryos, just like the abortion pill,” says the president of the American Association of Pro-Life Obstetricians and Gynecologists. On the other hand, people argue that if Plan B can be sold in the US, and that too over the counter, than why can’t EllaOne? We’ll just have to wait and see what decision the FDA will make.

Birth Control Buzz is a service company that provides birth control prices, types of birth control(prescription required), health administrative services, and birth control statistics predominantly to US patients seeking to purchase pharmaceuticals on-line. For more information, call 1-866-868-8850 or visit http://www.birthcontrolbuzz.com/.