FDA Approves First Period-Free Oral Contraceptive - Lybrel
Thursday, May 31, 2007
Ijeoma Eleazu, PharmD
On May 22nd 2007 the Food and Drug Administration approved the first low dose combination oral contraceptive (OC), Lybrel. This drug offers women the opportunity to gain period-free status over time i.e. women who use it over a period of time may eventually become cycle-free. Lybrel is for women who want a form of contraception and are interested in putting their menstrual cycle on hold. By lowering the production of hormones that make pregnancy possible, the drug stops the body's monthly preparation for pregnancy.
The active ingredients in Lybrel, levonorgestrel and ethinyl estradiol, are not new and in fact are available in other OC's currently on the market. The difference is that other OC's have either a pill-free period or some placebo pills that last anywhere from 4 to 7 seven days, during which time the menstrual cycle is prompted. With Lybrel, the active pill is taken for 365 days (366 in a leap year :) ) with no placebo or pill-free period. Even though women who use this medication may have no scheduled period, they may experience some breakthrough bleeding or spotting (most likely to occure during the first 3 to 6 months of use). When discussing whether or not to use this medication with their healthcare practitioners women should carefully weigh the inconvenience of having unplanned episodes of breakthrough bleeding and spotting against the convenience of not having a regular menstrual period. The incidence of unscheduled bleeding during the clinical trials decreased over time in most of the women who continued to take Lybrel for a full year. Lybrel did not appear to affect a return to menses nor did it appear to delay a return to fertility during the clinical trial period.
Another issue to be aware of for women who use this drug is that because there is no monthly bleeding during use, pregnancy may be difficult to recognize. Women who suspect they may be pregnant or have symptoms of pregnancy like unusual breast tenderness, or nausea and vomiting, should take a pregnancy test AND contact their healthcare provider.
Lybrel is not for every woman. Women who have had a heart attack, blood clots, stroke, certain liver diseases or cancers, unexplained vaginal bleeding and those who are or may become pregnant should NOT use Lybrel, or any other OC for that matter. Per a warning on the manufacturer's label, cigarette smoking increases the risk of serious cardiovascular side effects from the use of OC's.
Lybrel, manufactured by Wyeth Pharmaceuticals, is available by prescription only and is expected to hit pharmacy shelves in the U.S. in July 2007.
Photos courtesy of Emuishere Peliculas and Katie Tegtmeyer
Labels: birth control, birth control pill, contraception, lybrel, oral contraceptive, pregnancy, pregnant, the pill, wyeth
6 Comments:
At Fri Jun 01, 02:07:00 PM 2007,
Anonymous said…
So can it delay the menopause? And which hormones are increased and decreased with this drug?
Tiggy.
At Mon Jun 04, 10:31:00 AM 2007,
Ijeoma Eleazu, PharmD said…
Hi Tiggy and thanks for submitting your comment. The manufacturer of Lybrel does not address any effects of the drug related to menopause so unfortunately I cannot comment on that. In response to your second question, Lybrel works by suppressing the gonadotropins, the primary ones of which are Luteinizing Hormone (LH) and Follicle Stimulating Hormone (FSH).
At Tue Jul 17, 05:27:00 PM 2007,
Anonymous said…
Can Lybrel control acne?
At Wed Jul 18, 11:20:00 AM 2007,
Ijeoma Eleazu, PharmD said…
Hi Anonymous, the only FDA-approved indication for Lybrel is for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Whether or not it can control acne is not something the drug manufacturer addresses so I cannot address that either. Thanks for reading and for your comment!
At Thu Oct 04, 07:09:00 PM 2007,
Anonymous said…
Are the serious side effects of Lybrel serious enough that this pill should only be prescribed to a healthy person when really needed, for example, to prevent pregnancy? Or is it worth it to take this drug only to prevent periods?
At Mon Oct 08, 10:03:00 AM 2007,
Ijeoma Eleazu, PharmD said…
Hi Anonymous, thanks for reading the blog and asking your question. Over the period of a year, Lybrel does expose women who take it to more of the hormones than other conventional oral contraceptives containing the same/similar strength of the hormones. Serious side effects are possible with all oral contraceptives though and these can include blood clots and strokes. Everyone responds differently and though certain factors may put one at a higher risk of developing these serious side effects, there is really no way to determine for sure who will be affected and who won't. The determination of whether or nor one is a good candidate for Lybrel is one that should be discussed with one's personal OB/GYN. I hope this information is helpful to you.
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