5-Days-After-Sex Pill Gets FDA Panel Nod

[jerney]

June 17, 2010 -- A new emergency contraceptive fully effective for five days after sex should be approved by the FDA, the federal agency's expert advisory panel says.

By 11-0 votes, the panel found Ella to be safe and effective.

The drug, to be called Ella in the U.S., already is approved in Europe and sold there as EllaOne.

Currently, the only other approved emergency contraceptive is Plan B One-Step. Although Ella likely will be available only by prescription, Plan B is approved for over-the-counter sale to women aged 17 and older. Women younger than age 17 must have a prescription.

The two emergency contraceptives work differently:

* Plan B One-Step contains levonorgestrel, a progestin hormone used in lower doses in many birth control pills.
* Ella contains ulipristal, a non-hormonal drug that blocks the effects of key hormones necessary for conception.
* Plan B should be taken as soon as possible after sex. It may work for up to 72 hours, but is ineffective once the hormonal surge that leads to ovulation occurs.
* Although emergency contraception should not be delayed, Ella's efficacy does not fade for 120 hours (five days) after sex, regardless of whether the hormonal surge has occurred.

One possibly serious drawback to Ella is that it may be less effective in obese women. In a 6-5 vote, the panel said no specific labeling should be required to address this issue.

The most common side effects of Ella are nausea, headache, painful menstruation, abdominal pain, fatigue, and dizziness.
Can Ella Cause Abortion?

Ella belongs to a class of drugs called selective progesterone receptor modulators. The only other approved drug in this class is mifepristone, better known as RU-486. Mifepristone is approved for use as part of a regimen that induces abortion.

Because it is better absorbed by the body than mifepristone, Ella can be used at low doses that prevent conception but that should not cause abortion.

By a unanimous vote, the panel said there was no need for Ella to carry specific labeling warning against off-label use -- the use of a drug for a purpose other than the one for which it was approved. Nor was there a need for the manufacturer to conduct specific physician education on the issue.

It remains unclear whether Ella might increase the rate of spontaneous abortion in the few women who become pregnant despite using the drug.

Among women trying to become pregnant (and thus not taking emergency contraceptives), about 15% have a spontaneous abortion during the first trimester.

In clinical trials of Ella, 110 women who took the emergency contraceptive -- about 2% of study subjects -- became pregnant. As might be expected, 15% had spontaneous abortions. Another 66% had elective abortions, but for 12% of the women pregnancy results are not known.

"The actual spontaneous abortion rate could have ranged between 14% (assuming that none of these 11 pregnancies resulted in spontaneous abortion) to 27% (assuming all of these 11 pregnancies resulted in a spontaneous abortion)," FDA staff noted in a briefing document presented to the panel.

Nevertheless, the panel strongly recommended against requiring women to undergo a pregnancy test before taking Ella.

In Europe, HRA Pharma has established a post-approval study to gather information on pregnancy outcomes for women who take the drug. The panel recommended that the FDA make extension of this program to U.S. women a condition of approval.

Although the FDA is not required to follow the advice of its advisory panels, the favorable report submitted to the panel by FDA staff suggests that the agency will follow the panel's advice.

http://www.webmd.com/sex/birth-contr...-fda-panel-nod

[Austin]

Wonder how many people wouldn't exist today if it wasn't for morally-based and or religiously-based laws which used to make it harder to attain birth control pills...probably a good amount of people.


Actually not so much a good thing for the tax-payer in the long run since most minorities in the U.S. don't make use of birth control anyways so this law like all the others will mostly affect European-descent people who are the true earners and entrepreneurs hence actually hurting future tax revenue in the long-run. Mexican's and blacks never use birth control so this means essentially birth control for whites/Asians while the uneducated masses spawn at uncontrollable rates and churn out welfare recipients for a shrinking earner population.

Mexican's refuse to use any form of birth control due to an ignorance-based, old-school variety of Catholicism and the fact that they can't afford it anyways. That and neither blacks nor Mexican's value education on average so pumping out welfare recipients is the next best thing.

[Psychonaut]

...most minorities in the U.S. don't make use of birth control...

There is one form that Black women are the most likely group to opt for.

[Austin]

There is one form that Black women are the most likely group to opt for.

Yes that's true but that does prove my point as well, they don't use any form of pills as birth control for the most part, they have to have abortions because they refuse to use the pills....

Blacks don't have their Mexican counterparts moral qualms over abortion. That is the greatest problem with Mexican's they don't abort due to their obsessive Catholicism...and oh does the church love that $_$

[Agrippa]

The main issue in this regard is always which variants being born and which not. The method as such is a progress insofar, as it is more convenient if you want to reach the goal, stopping pregnancy.

It is not necessary now advisable to "save every embryo", the only problem in this regard is if too many higher level womens tend to use it than lower level ones.

And the solution to this problem can only lie in a more community-Gemeinschaft-collective and family oriented society, in which this measure being only taken if needed and usually people get pregnant which want a child and can add someething to the better of the group.