Seasonale, the first birth-control pill to lessen the frequency
of a woman’s menstrual periods from 13 to four times per year, was
approved by the Food and Drug Administration Friday.
Developed from the same mix of small-dose estrogen and progestin
– hormones found in most birth control pills – a prescription of
Seasonale provides the user with 12 consecutive weeks, or 84 days,
worth of active pills. Furthermore, during the woman’s period,
Seasonale users are given a week’s supply of placebo tablets to
keep them in the pill-taking habit.
Seasonale’s medication period is significant in length compared
to conventional oral contraceptives that are taken each day for
only three to four weeks.
A clinical study from Eastern Virginia Medical School showed
Seasonale was just as effective in preventing pregnancy and does
not cause heavier periods. Side effects associated with regular
birth control pills such as headaches, nausea and blood clots may
also result from Seasonale.
Produced by New York-based Barr Laboratories, Seasonale would
cost about $1 per pill, comparable to the price of other mainstream
oral contraceptives. The company said the drug would be available
for prescription by the end of October.
Though the drug may seem like a quick fix for agitated women
ready to rid themselves of further inconvenience, the FDA warns
that for some women the drug may do more harm than help as
incidents of unexpected bleeding was one of the drug’s downsides
found in its clinical trial.
“Although Seasonale users have fewer scheduled menstrual cycles,
the data from clinical trials show that many women, especially in
the first few cycles of use, had more unplanned bleeding and
spotting between the expected menstrual periods than women taking a
conventional 28- day oral contraceptive,” according to the FDA.
FDA spokesman Scott Monroe said the effects of the drug will
vary. “Some will find they respond entirely as the product was
designed to function, and others will have increased
inter-menstrual bleeding to the extent that they choose not to
continue with the product.”
Though women have been using birth control for years to delay
menstruation, Seasonale is the first drug marketed specifically to
do that job.
“I’ve already heard of women using the pill to stop getting
their periods, so I think it is just an easier option for women who
are going to do it anyway,” said LSA freshman Sara Roedner.
During menstruation, the lining of the uterus is shed so that
excess tissue and unfertilized eggs can leave the body.
Prior to approval, the leading medical concern was whether four
annual cycles would be sufficient to allow the uterus to get rid of
any tissue that builds up. However, this should not be a concern as
most oral contraceptives including Seasonale work to completely
suppress growth of the uterine lining, said Lori Lamerand, vice
president of Planned Parenthood Mid-Michigan alliance.
Lamerand added that some women taking Seasonale may be
disconcerted without having a monthly period, a definite indicator
that they are not pregnant.
“It’s really about personal preference,” she said.
For Nursing sophomore Nina Pak, the words “unnatural” and
“weird” came to mind when hearing about the potential effects of
Seasonale.
“It’s like taking the easy way out,” she said.
LSA sophomore Tiffany Cho said, “It’s just as unnatural as
taking regular birth control … but I think I would rather have
four periods a year than 13.”
– The Associated Press contributed to this report.