Anonymous
Anonymous asked in Pregnancy & ParentingPregnancy · 9 years ago

Some info for you that don't think there's a "5-day after pill"?

Alright,I see these women from the UK asking about the five day after pill (the morning after pill that's been recently approved for use in the US by prescription only) and here's some info on it because apparently most women/people in the US haven't ever heard of this pill. What's your opinion on it? It can be used for up to 5 days after sex (kind of like plan B) and works better than plan B. It will be available by prescription only in the US. It's already available in the UK,and I"m just putting this out there b/c I've saw some women ask about it and people answer with total ignorance b/c they don't know about it.

FDA NEWS RELEASE

For Immediate Release: August 13, 2010

Media Inquiries: Elaine Gansz Bobo, 301-796-7567; elaine.bobo@fda.hhs.gov

Consumer Inquiries: 888-INFO-FDA

Editors note: Approved trade name is lower case ‘e.’

FDA approves ella™ tablets for prescription emergency contraception

The U.S. Food and Drug Administration today approved ella™ (ulipristal acetate) tablets for emergency contraception. The prescription-only product prevents pregnancy when taken orally within 120 hours (five days) after a contraceptive failure or unprotected intercourse. It is not intended for routine use as a contraceptive.

ella is a progesterone agonist/antagonist whose likely main effect is to inhibit or delay ovulation. Since May 2009, the prescription product has been available in Europe under the brand name ellaOne.

An FDA Advisory Committee for Reproductive Health Drugs discussed ella in June, 2010. The committee unanimously voted that the application for ella provided compelling data on efficacy and sufficient information on safety for the proposed indication of emergency contraception.

The safety and efficacy of ella were demonstrated in two Phase III clinical trials. One study was a prospective, multi-center, open-label, single-arm trial conducted in the United States; the other was a randomized, multi-center, single-blind comparator-controlled trial conducted in the United States, United Kingdom and Ireland.

Side effects most frequently observed with ella in the clinical trials include: headache, nausea, abdominal pain, pain/discomfort during menstruation (dysmenorrhea), fatigue, and dizziness. The profile of side effects for ella is similar to that of FDA-approved levonorgestrel emergency contraceptives.

According to the product’s labeling, women with known or suspected pregnancy and women who are breastfeeding should not use ella. A patient package insert also will be provided to ensure that women are fully informed of the benefits and risks involved in the use of ella.

ella is manufactured by Paris-based Laboratoire HRA Pharma. ella will be distributed by Watson Pharma Inc., of Morristown, N.J.

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  • 9 years ago
    Favorite Answer

    Very informative & Useful. Thank you for posting.

    And Just like with "Plan B" ...Women should be advised that ella™ should NOT be used as a form of birth control and should only be taken in emergency's. It also does not prevent against STD's.

    I've seen alot of young girls (& guys) on YA! recently reference plan B like it was an everyday form of BC. I also seen a post by a man who said that when his daughter reached a certain age that he was going to stock up her purse with "Plan B" to avoid any "mistakes" ... Instead of properly talking to her about sex and advising her of her alternative BC options if she was not going to remain abstinent. *smh*

  • Mary
    Lv 4
    4 years ago

    i ordered something to, says the same thing.......... :(

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