Seasonale Period Pill Approved By FDA

Menstrual Cycle Would Be Limited To Four Times Each Year

UPDATED: 10:15 pm CDT September 5, 2003

The Food and Drug Administration approved a new birth-control treatment late Friday that may help women cut their monthly cycles down to four times a year instead of the usual 13 times.

There are many times when it is inconvenient for a woman to have a period. On her wedding day, on a vacation or even when she is going to be out in the wilds for an extended period of time.

Until now, many gynecologists would tell you that if you keep taking birth control pills without a placebo, you can delay your period.

Now, Barr Laboratories of Pomona, N.Y., is taking one giant step forward with their new birth control pill called Seasonale. With Seasonale, a woman will only get her period once a season.

"Being on Seasonale has been great. Having a period but once every (four) months is less inconvenience. I have a lot more freedom," explained Angela Fontaine, a Seasonale clinical trial patient.

With Seasonale, you take a pill for 84 days and then only get your period once every four months.

Jocelyn Black, a student at Temple University in Philadelphia, has been doing something similar. She has been taking regular birth control pills without the placebos and has been getting her period every three months.

"It's freedom. You don't have to plan things around your period. You don't have to deal with the side effects such as moodiness, breast tenderness, crampiness -- anything like that," Black said.

Black's doctor was surprised she has been doing that. Her doctor is also her mother, Hester Sonder, and said she approves.

"Personally, I've been doing this myself for the last 11 years. And it's changed my life dramatically. I know it will change the life of my patients as well," Sonder said.

Now that Seasonale has been approved by the FDA, Sonder believes it will mean less pain for women with endometriosis and fibroids; and fewer PMS symptoms like bloating, abdominal pain, weight gain and migraines. It will also mean less emotional symptoms like irritability, moodiness, having a very short fuse, fatigue and not feeling very well.

However, Barr research president and chief operating officer Dr. Carole Ben-Maimon reminds potential users that Seasonale has the same side effects as any birth control pill.

"So there are women who will not be able to take Seasonale because they're over 35 and smoke or they have some other contraindication to the pill," Ben-Maimon said.

But for women who are able to take oral contraceptives, Seasonale provides an alternative.

"Women really deserve to have the choice," Ben-Maimon said.

Some doctors say if you take a poll of women, most will say if they were given the chance to reduce their number of periods from 13 a year to four just by changing their birth control pill, they would jump at the opportunity.

Here are some of the most common questions about Seasonale:
    Q: What are the side effects of Seasonale?
    A: Manufacturers say the pills are made of ingredients already in other birth control pills, so the side effects are the same.

    Q: How will PMS be affected?
    A: Seasonale hasn't been officially tested for premenstrual syndrome, but doctors and patients Health Watch spoke with, who have taken regular birth control pills for three months straight, said it definitely puts off PMS symptoms for three months.

    Q: Does insurance cover this pill?
    A: Barr Laboratories said if your insurance covers your pill now, it should cover Seasonale.

    Q: Will periods be normal when they only come four times a year?
    A: Women who have tested it, or used birth control pills to achieve the same effect, said they expected the worst, but actually had very light flows.

    Q: Is it true that anyone over 35 cannot take Seasonale?
    A: Any woman over 35 who smokes should not take Seasonale or any birth control pill. If she doesn't smoke, it will probably work, but she should ask her doctor first.

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