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Lybrel Safety – No

“Safe” is a relative term. The pill is safe in what way? If meaning relative to other birth control pills, it is just as safe physically. However, there are several considerations to keep in mind in regards to not just hormonal birth control, but the lack of a period in general.

On May 22, 2007 the U.S. Food and Drug Administration (FDA) approved Wyeth’s Lybrel for use as a female contraceptive. The 365 day pill was the first continuous birth control pill. This loss of the normal female cycle is reflected in the drug’s name; it was to liberate women from their monthly ovulation and subsequent bleeding. There is a problem though. One of the main side effects, and expected occurrences when using the birth control, is inconvenient, breakthrough bleeding.

Lybrel contains low doses of hormones previously used in other pills, a combination of ethinyl estradiol and levonorgestrel. The difference is that there are no placebo pills in the 28 day packs. The hormones are intended to suppress ovulation and thus prevent pregnancy. In clinical trials, very few women had difficulty returning to their regular cycle when stopping the treatment. Most who attempted to, were capable of pregnancy soon after stopping treatment as well. In this consideration they are “safe.”

There are problems with the continuous suppression however. One is not being able to recognize unplanned pregnancies by observing a missed period. There is the same chance for hormone fluctuations with Lybrel as there are with any other contraceptive, which could result in ovulation in some women, leading to unplanned fertilization and pregnancy. There is also some debate as to the long-term effect of cycle suppression on fertility and natural hormone production.

Lybrel Side effects

According to the manufacturer’s website, common side effects of Lybrel in clinical trials included vaginal bleeding, headache, menstrual cramps, nausea, and upper respiratory tract infections. Breakthrough bleeding is considered a common occurrence by both the manufacturer and the FDA. The FDA press release states, “[T]he convenience of having no regular menstrual periods should be weighed against the inconvenience of unscheduled or unplanned breakthrough bleeding or spotting.” In the studies, only 59% of women achieved amenorrhea (no period bleeding). This seems to indicate that pill is not useful for preventing a period, only as a contraceptive, which is what it’s marketed and approved for anyway. The gimick of no period actually only has a 2 out of 5 chance of being true.

General Oral Contraceptive Safety

All oral contraceptives, which rely on hormones to prevent pregnancy, have side effects. Serious risks are uncommon, but include blood clots, stroke, and heart attack. Cigarette smoking increases these risks, especially in women over the age of 35, and women should not smoke if on the medication. Women with certain heart or liver disorders should not take oral contraceptives. Also, breast cancer has been associated with estrogen hormones in some women.

Oral contraceptives do not prevent HIV infection or sexually transmitted diseases. Women who believe that they are pregnant, or are exhibiting symptoms of pregnancy such as nausea and tender breasts, should take a pregnancy test and see a doctor. Women should also consult a healthcare professional if lumps appear in the breasts, severe or sharp chest pains are felt, or if there is pain in the calf of the leg.

Taking all things into consideration, Lybrel is not what it’s cracked up to be and can be unsafe in the case of pregnancy or existing disorders.