FDA OKs new, five-day emergency contraceptive

[defendandprotect]

FDA OKs new, five-day emergency contraceptive

By MATTHEW PERRONE, AP Business Writer Matthew Perrone, Ap Business Writer – Fri Aug 13, 6:21 pm ET


WASHINGTON – Federal health officials on Friday approved a new type of morning-after contraceptive that works longer than the current leading drug on the market.

The pill ella from HRA Pharma reduces the chance of pregnancy up to five days after sex. Plan B, the most widely used emergency contraceptive pill, begins losing its ability to prevent pregnancy within three days of sex.

The Food and Drug Administration approved the drug Friday as a prescription-only birth control option. The ruling clears the way for U.S. sales of the drug, which is already approved in Europe.


Studies of ella by its manufacturer showed the drug prevented pregnancies longer and more consistently than Plan B.

In a head-to-head trial between the two drugs, women who took ella had a 1.8 percent chance of becoming pregnant, while women who took Plan B had a 2.6 percent chance. Experts tracked nearly 1,700 women who randomly received one of the two pills within three to five days of having unprotected sex.

Plan B is made by Teva Pharmaceuticals and is also marketed in several generic versions. Unlike ella, Plan B and other generic versions are available without a prescription for women 17 years and older.

HRA Pharma did not request over-the-counter status for its drug.

MORE ...
http://news.yahoo.com/s/ap/us_birth_control_pill_fda

[niyad]

1. well, that sounds like some good news on the pharma front for a change.

but, I wonder why they didn't ask for over-the-counter status for it? would make the little fundies' heads explode even more, wouldn't it? after all, they can't (or at least, have not so far) managed to picket every pharmacy counter and watch every drug being sold.

[Travis_0004]

2. There are a few reason why it shoudn't be OTC

Are there some dangerous (but rare) side effects? Are the strict rules you have to follow when taking the pill? Is it dangerous to take if you are on other medications? Some pills a doctor should prescribe for saftey to the patient.

If none of those apply, then OTC makes more sense.

I would wonder if getting FDA approval is easier for prescription pills than OTC. If that is the case, then I can see them going prescription, to get it on the market, then try to switch to OTC later on.

[Warpy]

3. Mostly, they didn't want to rile up the wingnuts

so they applied to make it prescription, first.

The problem is that this is largely unworkable. You can't just drop in and see your Ob-Gyn for a quick scrip, although some of them will call it in if you call them for it.

Eventually, once it's been on the market as a prescription drug for a length of time, they'll apply to make it OTC. If it has a good safety record, that's when it will become an OTC option.

I think they were smart doing it this way.

[kestrel91316]

4. Gosh. Thank you for your paternalistic concern. We little airheads

are so grateful for you working so hard to make our lives safer and better.

[niyad]

5. indeed we are--after all, we can't possibly read instructions, or follow directions, or. . .

[niyad]

6. how many people die each year from prescribed drugs? how many women die from complications from

pregnancy?

[Warren DeMontague]

7. I think as long as there are Jesus-drunk pharmacists willing to hold peoples' prescriptions hostage

oral contraceptives should be available OTC, no questions asked. You can get 'dangerous side effects' from ibupofren. Or tylenol. Or scotch.

[defendandprotect]

8. From the article . . .

The most common side effects with the drug included headache, nausea and abdominal pain, according to an FDA release.


Obviously, nothing that compares with the damaging and killer drugs the pharm companies have on the

market --

[defendandprotect]

9. 5 days is a much better option that trying to react in 3 days... but needs to be OTC....