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   Barr Gets Approval for Extended Oral Contraceptive

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Topic: Barr Gets Approval for Extended Oral Contraceptive (Read 297 times)

Rhune
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Barr Gets Approval for Extended Oral Contraceptive
« on: Sep 7^th, 2003, 6:25pm »

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Barr Gets Approval for Extended Oral Contraceptive
Fri Sep 5, 6:19 PM ET

NEW YORK (Reuters) - Barr Laboratories Inc. on Friday won U.S. regulatory clearance to market the first birth control pill designed to cut the number of a woman's menstrual cycles to four a year from 13.

The company said the extended-cycle pill, called Seasonale, will be available by prescription at the end of October.

Women will take Seasonale tablets for up to 84 consecutive days, followed by a seven-day placebo interval. Most oral contraceptives currently sold in the United States are based on a regimen of 21 treatment days followed by seven days of placebo.

The placebo cycles allow for periods of bleeding, so most women on oral contraceptives have about 13 menstrual cycles each year that cleanse the linings of their wombs.

"It's fantastic that women are going to have a choice about when and if they want to have periods," said Dr. Anita Nelson, professor of obstetrics and gynecology at the University of California, Los Angles School of Medicine. "We've come to realize that the periods that women have when taking the pill are not menstruation, they're artificial."

Many doctors have for years prescribed oral contraceptives for the longer duration off-label to help women manipulate the frequency of their menstrual cycles, which for many can be accompanied by discomfort, pain and mood swings.

Barr Labs, based in Woodcliff Lake, New Jersey, decided to hold clinical trials of the contraceptives in order to get official FDA approval for the extended cycle use.

The company effectively tested an older oral contraceptive called Nordette, originally made by Wyeth, for the longer duration.

Clinical trials of Seasonale found that it prevented pregnancy and was as safe as traditional birth control pills. The most common side effects were colds, headache and intramenstrual bleeding or spotting.

However, some health advocates oppose the idea of tinkering with the cycles, arguing that the bleeding is a necessary cleansing process and that to suppress it is unhealthy.

"Many women suffer significantly while they have their periods. If you can use the pills to take away periods entirely for three months or so at a time, that can make a huge contribution to women's health, to their quality of life and to their productivity," Nelson said.

The annual U.S. oral contraceptive market is about $2.8 billion and growing at 5 percent to 6 percent each year, according to a Barr spokeswoman.

Shares of Barr Labs, which rose 57 cents to close at $69.45 on the New York Stock Exchange, were not trading after hours.

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azure
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Re: Barr Gets Approval for Extended Oral Contracep
« Reply #1 on: Sep 7^th, 2003, 6:42pm »

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ok, not real sure what I think of this. Sounds awesome in the general sense, but I am afraid if you mess with natures' intent of the way the human body works too much, it may not be wise.

anyone else have an opinion? David? bumper? lol Wink

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Rhune
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Re: Barr Gets Approval for Extended Oral Contracep
« Reply #2 on: Sep 7^th, 2003, 7:04pm »

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I've used the depo shots before, and when you use those, you have no periods at all once you pass the 6 month mark or so. You don't start having them again until up to a year after you've gone off. Now I was able to go off these shots twice and get pregnant, so as far as that goes, it didn't seem to harm me at all. For an adult I don't see a problem, but I certainly wouldn't prescribe any kind of medication like this to a developing teen. I can see a potential for problems there.

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azure
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Re: Barr Gets Approval for Extended Oral Contracep
« Reply #3 on: Sep 7^th, 2003, 7:14pm »

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good point rhune
Cheesy

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MzWings
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Re: Barr Gets Approval for Extended Oral Contracep
« Reply #4 on: Sep 7^th, 2003, 8:31pm »

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on Sep 7^th, 2003, 6:42pm, azure wrote:

ok, not real sure what I think of this.

anyone else have an opinion? David? bumper? lol Wink

EEEEEEEEEEEK Azure. Why are you asking David or Bumps for an opinion? Just curious?

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Bumper
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Re: Barr Gets Approval for Extended Oral Contracep
« Reply #5 on: Sep 7^th, 2003, 10:30pm »

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on Sep 7^th, 2003, 6:42pm, azure wrote:

Thanks for asking. I have decided that I will NOT take this medication!! I just don't think it's right for me. Grin

. . . . Besides, according to the announcer on those TV commercials, I ALREADY have to ask my Doctor if I can take Paxil, Flonaise, Prilosec, Oxroot, batwing, terminix, armorall, plasteroparis, eye of nuet, and a zillion other damn weird named perscription drugs advertised on TV!! Wink

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Addams
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Re: Barr Gets Approval for Extended Oral Contracep
« Reply #6 on: Sep 7^th, 2003, 10:34pm »

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which marks an interesting difference between Canada and the United States. Prescription drugs cannot be advertised in Canada except to doctor's in medical magazines.

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Rhune
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Re: Barr Gets Approval for Extended Oral Contracep
« Reply #7 on: Sep 7^th, 2003, 10:41pm »

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Oh they market the hell out of them here. My favorite was the commercials for Allegra. They have this woman dancing through this field of flowers and this sweet woman's voice over the top talking about how wonderful Allegra is and how you can be free at last! Then it ends with her sweetly listing the side effects, ending with "and in some rare cases, death. Ahhhh! Allegra!"

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MzWings
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Re: Barr Gets Approval for Extended Oral Contracep
« Reply #8 on: Sep 8^th, 2003, 9:54am »

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True what addams said about the ads. Did you know you can't purchase OTC Alleeve? You can get it only with a script.

ITA agree with you Rhune - about giving this type of contraception to young females. For this one - in particular - I wouldn't prescribe it to a female under 25 yo. Bumper, OTOH - would qualify at his age... :laff:

However, eye of newt - nope on that one.

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azure
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Re: Barr Gets Approval for Extended Oral Contracep
« Reply #9 on: Sep 8^th, 2003, 10:06am »

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on Sep 7^th, 2003, 8:31pm, MzWings wrote:

EEEEEEEEEEEK Azure. Why are you asking David or Bumps for an opinion? Just curious?

lol wings I was merely kidding when I asked david and bumper for their opinions

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david
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Re: Barr Gets Approval for Extended Oral Contracep
« Reply #10 on: Sep 8^th, 2003, 10:52am »

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OMG someone actually WANTS my opinon lol To be honest whenever I hear of these NEW drugs I get leary of them. I prefer to allow others to experiment on themselves. Personally I would not advise anyone to take any new drug until others have done so for sometime to make sure there arent any problems. (Can you say FEN FEN?) It surely would entice many women to reduce the amount of periods they have but I still remain cautiou. I also know someone who took depo shots and she NEVER got her period back after going off!

P.S. What makes you think I know anything of Contracetives? Remember I have five kids lol

« Last Edit: Sep 8^th, 2003, 10:58am by david »

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Rhune
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Re: Barr Gets Approval for Extended Oral Contracep
« Reply #11 on: Sep 8^th, 2003, 1:20pm »

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on Sep 8^th, 2003, 10:52am, david wrote:

P.S. What makes you think I know anything of Contracetives? Remember I have five kids lol

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david
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Re: Barr Gets Approval for Extended Oral Contracep
« Reply #12 on: Sep 8^th, 2003, 9:43pm »

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Well think about it Grin

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