Extended Oral Contraceptive Formulation Approved by FDA

Wednesday, September 10th 2003

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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 from 13 to 4 a year.

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

The new pill is novel not because of its active ingredients, they are the estrogen and progestin already contained in the birth-control pill Nordette, but because of its dosing schedule.

Women will take Seasonale tablets for up to 84 consecutive days, followed by a 7-day placebo interval. Most oral contraceptives currently sold in the United States are based on a regimen of 21 treatment days followed by 7 days of placebo pills. The hormones stop ovulation, while the placebo cycles allow for periods of menstrual flow, so most women on oral contraceptives have about 13 menstrual cycles each year.

"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 Pomona, New York, decided to hold clinical trials of the contraceptives to get official FDA approval for the extended cycle use.

The company, which already markets 13 types of generic birth control pills, effectively tested Nordette, originally made by Wyeth, for the longer duration.

A spokeswoman for Barr said the cost of Seasonale will be comparable to other branded oral contraceptives, which sell for about $1 a pill.

The presence on the market of an FDA approved extended-cycle product is expected to increase awareness of the option.

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 and headache as well as more bleeding or spotting between periods than is experienced with traditional birth-control pills.

The FDA said risks of Seasonale are similar to those of conventional oral contraceptives, including increased risk of blood clots, heart attack, and stroke, especially for smokers.

Still, some health advocates oppose the idea of tinkering with menstrual 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 3 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," Dr. Nelson said.

Source: Reuters Health

Footnote from Leanne James

When I read this article I was shocked! Isn't menstruation a normal part of being a women? How could any women think that having only four periods a year could be good for their body? How can we think that the listed side effects of "colds and headache as well as more bleeding or spotting between periods than is experienced with traditional birth-control pills, as well as the similar risks of other oral contraceptives, including increased risk of blood clots, heart attack, and stroke, especially for smokers" be acceptable? As a Naturopath I say, "If you have problems relating to your menstrual cycle, does it not make more sense to seek professional advice to find the reason for the problem? Having only a few periods a year is not an answer to the problems. I believe we would be under a grave misconception to think there would not be long-term health effects from only menstruating four times a year". Think about it.

Footnote from Ideal Health

The following supplements are all useful for . Use the links for more information.

AKN Skin Care
DIM
Femaprin
PM-Tea
Womens Iron

Related health information can be found here:

P.M.S
Acne
Anaemia
Blood Clots
Candida
Hormonal Changes
Liver Problems
Menustrual Problems
Stroke
Water Retention
Cardio Vascular Health

If you need help or advice, you are welcome to email our naturopathic team with your health question.

Disclaimer: The health information presented here has been written for the New Zealand health consumer. It is of a general nature and is only intended to provide a summary of the subjects covered. The information is not intended to be comprehensive or to provide medical advice to you. While all care has been taken to ensure the accuracy of the information, no responsibility or liability is accepted, and no person should act in reliance on any statement contained in the information provided. All health ailments should be treated by a qualified health professional.

 

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