Lybrel is a recently FDA approved birth control pill containing compound combination of the progestin levonorgestrel and the exogenous estrogen ethinyl estradiol or just ethinylestradiol the same hormones as other “pills” only in lower amounts than normally seen in oral contraceptives. It is taken every day at the same time and has been proven to quite effective at preventing pregnancy but with a marked difference from other birth control medications – you will not have your period while taking Lybrel.

There has been some controversy since the arrival of Lybrel on the market. Some have said that it is just unnatural for women not to have their period. Others have hailed Lybrel as another step forward in the women’s movement freeing women from the burden of their monthly cycle. The experts have said the controversy is unwarranted since birth control itself is an unnatural situation and men and women have been practicing it in some form or another for years.

Lybrel was the next logical step forward in the evolution of hormonal use birth control. There are some women who have a terrible time with their periods and menstruation is a debilitating time for them every month. Lybrel is not for everyone for sure but to refer to it as anti-female is stepping over the line of common sense. When you consider a women who has painful PMMD or Premenstrual dysphoric disorder, Lybrel and its no period element is a Godsend.

PMMD can be so acute in some women that they need hospitalization and pain control measures for comfort. They lose time from work and caring for family and themselves is nearly impossible when they are doubled over in pain. A total of five percent of women suffer from incapacitating symptoms during their period and another seventy five percent have some form of discomfort associated with their periods or the more “mild form” of PMS.

Most women would be thrilled to put an end to their periods every month. Some women experience such a heavy flow that they must double up their protective layers and frequently change their sanitary protection throughout the day during heavy periods lasting up to 3 days. One might think that men a behind some of the controversy but other women who have lesser challenges at menstruation time seem to categorize all females.

“I’m not bothered by my period; it’s a fact of life so why should others be any different. They should quit complaining”. The lack of empathy from men, women and even some physicians comes from a lack of understanding and education about the subject. Natural or abnormal, a women’s monthly cycle is a personal thing and every situation should be looked at based on its severity and what can be done to improve the condition of an individual’s existence. If Lybrel can assist with this than it is worth having the “no period pill’ available.

Lybrel was approved as the first nonstop usage medication designed to prevent unintended pregnancy in May of 2007. This breakthrough medication was developed and manufactured by Wyeth based out of Philadelphia, Pennsylvania. There currently is not a generic brand of Lybrel available and with Wyeth holding the rights to it via patent until 2018, there likely will not be a generic version available for a while.

That said there is a row brewing over the Wyeth patent and lawsuits are beginning to make their way around the pharmaceutical world. Another drug company has filed suit against Wyeth regarding the patent and is hoping for an opportunity to market a generic brand of Lybrel if even for the short period of time that a court may intervene, perhaps 180 days.

Often a drug company will have license agreements in different countries and drugs will be marketed to those countries under a different trade name. That is to say, different trade names for the exact same drug only in a different country and usually for less money. Therefore, in theory you could find Lybrel for sale in a different country’s pharmacies under a different name and selling for fifty to eighty percent cheaper than for the brand name, in theory of course.

Lybrel is sold in a twenty-eight day packet of low dosage pills that include 90 micrograms of levonorgestrel, the progestin part of the compound combination and twenty micrograms of the synthesized estrogen, ethinylestradiol. These two hormone derivatives make up the active ingredients in many other FDA approved oral birth control pills on the market currently.

Everyone reacts differently to medication and it is no different with Lybrel. One women’s experience was noted online when she offered that she had been ingesting Lybrel for 4 months and her periods were quite light with spotting after the first month. About three and a half months into her Lybrel regimen she began to bleed heavier but was still only spotting then within a week or so of that she began to bleed excessively passing large clots for a half hour.

She was aware of the cautions and called her doctor but this has left her wondering if she perhaps miscarried or was developing something more dangerous. She has by now likely seen her doctor and is being well treated but this amplifies the point that Lybrel may not be for everyone. Everybody’s tolerance to drugs is different and so they should be treated and prescribed to as individuals.

Another women wrote that she had been taking Lybrel for three months and was having a raft of side effects ranging from mood swings, spotting and weight gain. She experienced many similar side effects when taking other brands of oral contraceptives so the problems is being narrowed down to intolerance to hormonal medications overall and perhaps a physiological condition as yet undiagnosed but suspected endometriosis has been speculated. Regular exercise was started and this seemed to alleviate the symptoms somewhat overall but things are still far from better.

Both the drug manufacturer Wyeth and the FDA have noted and made clear that their research data gives no indication that there are any long term health hazards or added risks with Lybrel. There is no reason to think otherwise based on the active ingredients in Lybrel and the history of other oral contraceptives that contain the same active elements. Lybrel is after all a low dose birth control medication when compared to others on the market. The question then needs to be asked if the protocol or regimen of nonstop, continuous medicating with no placebo interval giving the body a recuperative phase, is this a factor in severe, hyper symptomatic side effects?

Certainly many women have found Lybrel to be an incredible relief. One women wrote that she was having an extremely difficult time with her period ever since she was thirteen years old and had her first cycle. She was now a young woman attending university and when she began missing classes and found her grades were suffering because of the debilitating effects of her period, she consulted a physician.

She was placed on a regimen of Lybrel and after some initial adjustment to the new medication her painful periods that kept her bedridden in the fetal position were no longer an issue. She felt like a new women and the freedom she was now realizing made her feel like “shouting from every rooftop” about how great her experience was with Lybrel, she called it her miracle. Clearly there is a place for a new drug like Lybrel and the debate will continue while it finds itself a place on the shelves of pharmacies around the world.

Contraceptives

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The oral contraceptive Lybrel is fairly new to the U.S. Market. It is FDA approved for use as a birth control pill. What makes Lybrel unique from other oral contraceptives is that the women taking Lybrel never has her period while on the drug. This means there is a side benefit associated with Lybrel – these women also do not suffer the common uncomfortable distractions associated with menstrual cycles such as moodiness and pelvic region cramping.

Lybrel is mainly used as a contraceptive medication but there are other reasons why a woman might take Lybrel. It contains a combination of female hormones that thwart a women’s ability to ovulate. It is doing its job if the sperm has a difficult time reaching the uterus because of cervical mucus changes and alterations to the lining of the uterus. It also becomes more difficult for the ovum when fertilized, to attach itself to the wall of the uterus.

Lybrel s prescribed primarily as an oral contraceptive but there are occasions when a treating physician will prescribe Lybrel for an “off label” purpose. This means that a particular medication is approved by the FDA for a specific purpose but through the use of that drug or observations made during drug trials, other benefits are found for the drug. The practice of off labeling has been around for quite awhile and chances are many people have an off label prescription in the medicine cabinet now in generic form.

Off label uses for Lybrel are being utilized to treat these subsequent ailments.
• Treatment of variations of acne
• Serious Menstrual blood loss
• Irregularity of menstruation cycles
• Premenstrual dysphoric disorder or PMMD is a severe form of PMS present in about 5% of menstruating women. PMMD symptoms are very debilitating to those who suffer from it.

Contraceptive medications such as Lybrel that contain Estrogen based hormones; in this case [ethinylestradiol] should always be taken with caution. The caveats in this case are health risks that must be weighed against the benefits of taking Lybrel. You should avoid Lybrel if you have a history of stroke or you have experienced blood clotting or have circulatory problems particularly due to diabetes.

Stay away from Lybrel if you have a cancer caused by hormones such as cancer of the breast or uterus, any atypical bleeding from the vagina, cancer of the liver or liver related illnesses. High blood pressure can be a serious problem for potential Lybrel users, migraine headaches, and heart disorders related to valves, a history of jaundice from taking birth control pills. Ingesting hormones could amplify your vulnerability to blood clots, stroke, and heart attack via coronary heart disease particularly if you are a smoker over the age of 35.

Before taking Lybrel you should be aware of other risks associated with it such as birth defects. If you are a pregnant women you should avoid using Lybrel. See your doctor immediately if you happen to become pregnant or if you skip to menstrual cycles back to back. If you are a recent mother avoid Lybrel for 4 weeks post delivery before starting the Lybrel protocol and wait 6 weeks if you are a nursing. The following is a list of conditions that will justify avoiding Lybrel use:

• As mentioned earlier blood clots and stroke in your past.
• Circulation problems or diabetic neuropathy
• Any cancers caused by hormones
• Unnatural vaginal blood loss
• Disease of the liver, jaundice due to birth control pills, or cancer of the liver
• High blood pressure classified as severe
• Extreme migraine headaches
• Any sort of valve problems with the heart
You should also consult with your physician before taking Lybrel if you have any of the following risks:
• Coronary heart disease, congestive heart failure, angina, blood pressure problems, or a record heart attacks at all.
• Are you overweight or have cholesterol problems?
• Have you ever suffered from or a being treated for depression?
• Disease of the gall bladder
• Or diabetes
• Have you ever suffered from seizures, epileptic or otherwise?
• Have you had an asymmetrical menstrual cycle?
• Do you have a history of breast fibroids or cysts? What about lumps in general, nodules or a past questionable mammogram?
• Have you ever suffered from uterine fibroid tumors?
• Varicose veins or TB?

Hormones can be passed to your newborn through breast milk so avoid Lybrel when breast feeding and understand that your creation of breast milk may be hampered due to taking Lybrel. You should simply avoid Lybrel while breast feeding period.

You should take Lybrel exactly how your physician or clinician has recommended your dosage should be taken. Lybrel should never be taken in great quantities, nor should you be taking it for a long period of time. Seriously discuss with your physician what your exit strategy will be from taking Lybrel over the long term or any form of contraceptive for that matter. You should take your first dose of Lybrel on day one of your period or the first Sunday after the beginning of your cycle. Your doctor will give you precise information.

As with most form of oral birth control you may be advised to use alternate methods of birth control for a few weeks while the Lybrel adjusts in your system so caution is recommended. Lybrel is a low dose birth control pill that distributes minimum effectual doses of hormones into your body on a daily basis. Certain types of birth control pills will work on a twenty eight day cycle with three weeks on and one week off. For three weeks you will take a different strength pill for each of the three seven day cycles [i.e. Ortho 7-7-7]. The fourth week you will have your period and this should happen like clockwork, hence the cycle regulation factor of contraceptives.

Some twenty eight day birth control pill varieties will have a seven day “placebo” or “reminding” pill to make it easier to remember to take your next round of pills. You will likely experience your period during the placebo pill week.

Many clinicians believe that there is really no healthful reason to experience a period during the time you are on a birth control protocol. Going without a period for 365 days with Lybrel is really no different than taking the traditional twenty-eight day cycle pill since both are avoiding chance of pregnancy by hormonal means and gynecologists, for the most part, like what they see with Lybrel.

Many physicians have been advising their patients to forget about the seven day placebo tablets in at the end of a cycle and simply begin the new pack. The method to their thinking is the blood flow is relatively minor anyway and is not a true period since the uterus is not actually discharging the lining and the process is far from a natural period. There is also the fact that most discomfort when menstruating occurs during the week of the flow so continuing to take the pill means alleviating this discomfort for many women. A full 75% are known to suffer from some level of Premenstrual discomfort.

One Professor of gynecology and obstetrics summed it up when he said that women do not need to have a period and added that throughout history women were either pregnant or breast feeding in their child bearing years and thus were not experiencing their periods anyway. Some have speculated that since birth control pills were prescribed on a monthly cycle over the years allowing for the fourth week bleeding period; this was a reflection of what women themselves would want. This theory not being entirely physiologically necessary.

Lybrel is to be taken on a daily basis and never more than twenty four hours between 1 dose and another. When one package is finished, the next one should be started immediately the next day preferably at the same time to make it easier to remember. It is critical to take your Lybrel as prescribed since if you miss a pill or are erratic with your routine you may get pregnant. Always be sure to have your prescription refilled early to ensure you have enough on hand for a seamless dosage protocol.

In the event you are seeing a specialist or having surgery for any reason you should inform the new doctor of your Lybrel use. This goes for any medical testing you may be required to undergo. If it is mandatory that you must have complete bed rest it may be necessary to cease using Lybrel for a bit, you can start again when needed. Many physicians want to see their Lybrel patient on a regular basis especially if you are taking Lybrel for an off label reason. Otherwise most doctors will be satisfied with an annual or semiannual appointment and give you refills at that time. Always store your open and unused Lybrel at room temperature and avoid moisture, heat, and direct light.

Remember that if you miss taking a Lybrel pill you are enhancing your risk factor for getting pregnant. If you happen to miss taking your next “live” pill you should have two pills the day you remember than continue to have one pill daily for the remainder of that pack. Should you forget to have two “live “pills back to back missing two days in each of week one and two, take two pills a day for two days straight than follow up with your regular one pill a day for the remainder of the pack. You should also use alternative birth control methods for the next week or more to be on the safe side.

If those two forgotten pills occur in week three of your regimen or if you forget three “live” pills back to back to back in any of the three previous weeks, toss out your old pack and immediately start a new one on that very day if you have been a day one user. If you start your regimen on a Sunday, continue to take a pill every remaining day until Sunday than throw away your old packet and begin a new one immediately that first Sunday.

With standard birth control if you miss a couple pills in a row, you may not have your period during that cycle; if you miss your period for two months consecutively you should call your doctor since you may be pregnant. If you take the twenty eight day – three week cycle pill and miss the one of the placebo week pills, toss away the remaindering placebo pills and keep taking a pill per day until the package is empty. There is no need to use alternate birth control if you forget your placebo pills.

You should immediately get emergency treatment if you feel you have taken too much Lybrel. If you have overdosed your symptoms could consist of vomiting and nausea as well as some vaginal bleeding. Always be sure to keep your Lybrel, or any medications, out of the reach of children and pets [if a pet eats your medication you can call an emergency pet poisoning hotline if one exists in your area for information].

While you are taking your Lybrel regimen there are some things you should be aware of and also avoid. It is important that you do not smoke if you take Lybrel or any other form of birth control, especially if you are more than thirty five years of age. Smoking has been proven to increase the chances you will have a stroke, venous thrombosis or blood clots or a heart attack. Smoking while on Lybrel is not something you should risk or take lightly.

Lybrel will not protect you from STD’s or sexually transmitted diseases and that is counting the AIDS virus or HIV. Using a condom will offer your only protection from STD’s, not oral contraceptives. Young adults or late teens should be particularly aware of this caution since many will depend and believe in what they hear rather than what they learn from knowledgeable sources such as school nurses, guidance counselors or family physicians.

Like most medications, taking Lybrel can result in some individuals experiencing certain side effects. Some are more serious than others are and may require immediate cessation of the medication. You should seek out immediate emergency medical assistance if you begin to show any of the following allergic reaction symptoms. Breaking out in hives, difficulty with your breathing, if you experience inflammation in your tongue, face, mouth area and throat.

Stop taking Lybrel and see your physician right away or get to an urgent care clinic if you experience any of the following harsh side effects:

• Any weakness or numbing sensation specifically if it is in one side of the body
• If you get a swiftly occurring headache, experience confusion or mental disorder, inner eye pain or vision problems, slurred speech, trouble balancing
• Chest heaviness or pain that radiates down to the arm and shoulder, nausea and sweats and a general feeling of poor health
• Migraine headaches with irregular patterns and harshness.
• Dehydration, nausea with stomach pain and no appetite, dark urine, jaundice or yellowing of the eyes and skin
• Swollen feet, ankles, and hands
• Depression, insomnia, lethargy, mood swings
Some of the lesser side effects with Lybrel could consist of:
• Mild nausea with vomiting, feeling of fullness and stomach spasms
• Painful breast or nipple soreness
• Facial skin pigmentation changes or blotches
• Excess hair growth or scalp balding
• Unexpected weight loss and diminished appetite
• Discomfort or contact lens trouble
• Vaginal itch or discharge
• Changes in menstrual cycle, diminished libido
• Head pain, nervous feeling, wooziness, general feeling of malaise

This list is by no means complete and Lybrel has only been on the market for a short time. You should notify your doctor if you sense any different feelings or experience unfamiliar discomfort.

There are other drugs that could interact negatively with Lybrel. Some will reduce the effect of the birth control aspect of Lybrel and could cause unintended pregnancy. So before you start using Lybrel make sure your clinician is aware of any other medications you have been prescribed and specifically discuss with your physician if you are on any of the following medications:
• Vitamin C regimen or ascorbic acid
• If you are taking any strength of acetaminophen brand name Tylenol
• Prednisolone or Orapred
• Respbid or Theo-Dur [Theophylline]
• The antibiotic Cyclosporine, Neoral, Gengraf. Antibiotics can reduce the effectiveness of the Lybrel
• St John’s Wort which is a natural herb that claims to successfully fight depression
• If you are taking any seizure medications
• Any barbiturates or sedatives such as Seconal [secobarbital] or phenobarbital [luminal or Solfoton] and you are cautioned about taking any AIDS or HIV medications or antiviral meds. Obviously with these latter contraindications you will want to speak to your physician about what your oral birth control options are if not Lybrel while medicating for such a serious illness.

Avoid using any new medications without discussing them with your physician first. This list is not absolute so discussing any new medications you introduce to your system could save your life or assist in avoiding certain unintended consequences. Any ill feeling after ingesting over the counter meds [OTC] or other prescriptions drugs, natural products or herbal supplements including any vitamins, minerals or naturopath remedies, tell your doctor. NEVER share your medication with anyone else and Lybrel should be used to treat only the condition that it was prescribed for, nothing else.

Contraceptives

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