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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/.

April 21, 2007

Emergency Contraception…..

Emergency Contraception Does Not Reduce Unintended Pregnancy Rate

By Taunya English, Associate Editor, April 17, 2007
Health Behavior News Service

The “morning after pill” may be a good option for individual women in crisis, but advance access to emergency contraception is no antidote for the national problem of unintended pregnancy.

Contrary to the fears of critics, the presence of Plan B does not provoke riskier sexual behavior.

According to a new review of studies, women who received an advance supply of birth control pills for emergency contraception had an equal chance of becoming pregnant as women who did not have early access to the pills.

The review draws conclusions from eight studies of more than 6,000 women in the United States, India and China.

Plan B is a well-known brand of emergency contraception pills, but many different types of birth control medication taken at higher doses can prevent pregnancy after sex. Treatment must begin within five days after unprotected sex – and sooner is better when it comes to EC.

“We had expected that easier access to emergency contraception could help women use the pills more quickly when they needed them, and that in turn – since EC is a time-relevant medication – this could help women avoid unintended pregnancy,” said lead reviewer Chelsea Polis.

“Our review is really about the effectiveness of advance provision as a strategy to reduce unintended pregnancy at a population level,” Polis said. “The review is not about the effectiveness of EC; that is a separate matter.”

The review appears in the current issue of The Cochrane Library, a publication of The Cochrane Collaboration, an international organization that evaluates research in all aspects of health care. Systematic reviews draw evidence-based conclusions about medical practice after considering both the content and quality of existing trials on a topic.M

In 2001, about half of pregnancies in the United States were unintended, according to the Centers for Disease Control and Prevention. Now, the United States is working to lower the unintended pregnancy rate to 30 percent by 2010.

Princeton University demographer James Trussell says easier access to emergency contraception will not slow the rate of unintended pregnancy in the United States.

“For individual women, it is definitely a last chance to prevent pregnancy after unprotected sex. But it is not going to have a major population impact because people will never use it enough,” he said.

The review found that emergency contraception use was higher among women given an advance supply of the birth control pills, but that increase in use did not translate to a drop in the pregnancy rate.

“Even though advance provision increased use, we don’t know if women were using EC at the times when they were at risk for pregnancy, when it was really needed,” Polis explains.

“If women aren’t going to use Plan B when they are given it for free in a clinical trial and are counseled beforehand about using it every single time they have unprotected sex, then having to go to CVS and having to pay $45 each time – it isn’t going to happen,” Trussell said.

Nonetheless, Polis said her review is not an argument against easier access to emergency contraception.

“Women deserve the chance to protect themselves from unintended pregnancy and EC is a safe, effective way to do that. Emergencies like rape, contraceptive failure and unprotected sex occur, and easier access to EC eliminates a medically unwarranted barrier to taking emergency contraception within the recommended timeframe,” she said. “So steps like making EC available over the counter are still incredibly important.”

When advanced access to emergency contraception was first proposed, critics worried that a medicine cabinet stocked with pills to prevent pregnancy would lead some women to be more promiscuous, have riskier sex or not use condoms.

The Cochrane review counters those concerns.

“We found there was absolutely no difference in sexually transmitted infection rates between the two groups. There’s absolutely no difference in terms of unprotected sex, condom use or changes in use of other contraceptive methods,” Polis said. “So it appears that advance provision of EC has no harmful effects in terms of risky sexual behaviors.”

Polis CB, et al. Advance provision of emergency contraception for pregnancy
prevention. (Review). Cochrane Database of Systematic Reviews 2007, Issue 2.

BirthControlBuzz is a service company that provides birth control prices, birth control types (prescription required), health administrative services, and birth control statistics predominantly to US patients seeking to purchase birth control on-line.

For more information on types of birth control call 1-866-868-8850 or visit http://www.birthcontrolbuzz.com/.

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/.