FACTS ABOUT ORAL CONTRACEPTIVES U.S. Dept of Health and Human Services National Institutes of Health When oral contraceptives were introduced in the United States in 1960, many women believed they had found the answer to the need for convenient, safe and reliable birth control. By 1965, "the pill" was America's leading contraceptive. With the 1970's came disillusionment: The pill was not perfect. While it was highly effective and convenient, it had many minor side effects and a few serious ones. Though severe complications were rare, "pill scare" reports created an aura of danger. Pill use dropped in the mid-70's. Today the pill has been put into perspective. It is not for everyone, but recent studies show it to be safe for most young, healthy, nonsmoking users. Despite widespread publicity on the pill's drawbacks, its benefits must be substantial. It is still the most popular reversible birth control method in America, with more than seven million women taking it daily. Two Decades of Research. Oral contraceptives are probably the most extensively studied medication in history, yet they are not fully understood. Twenty years of research has, however, brought much safer pills and a long list of guidelines to help doctors screen out women most likely to develop serious complications. The most important outcome of recent research is that groups of women with a high risk of developing pill complications have been identified. These include smokers, older women (the risks start to rise at 30), and those with a history of certain illnesses. While current knowledge is not precise enough to predict exactly which individuals will suffer serious pill complications, it is continually improving. New studies also show benefits of pill use, besides contraception, such as protection from pelvic inflammatory disease and other conditions. Many doctors today stress that women should be made aware of these benefits, as well as the possible problems, so they can make informed decisions about the pill. Research on oral contraceptives continues. Each year the National Institute of Child Health and Human Development (NICHD), a part of the National Institutes of Health, spends millions of dollars to evaluate current pills and develop better ones. This brochure, prepared by staff of the NICHD, describes the latest news on oral contraceptives. Today's Pills The most popular oral contraceptives are "combined" pills. These contain two synthetic hormones (an estrogen and a progestogen) similar to the hormones the ovary normally produces. When studies linked the amount of estrogen in birth control pills with serious side effects-including blood clots, heart attacks, and strokes- researchers developed new pill formulas with less estrogen. They also developed a progestogen-only pill known as the "minipill." Ten years ago, doctors often prescribed combined pills with 100 to 150 micrograms of estrogen. Today the Food and Drug Administration urges physicians to start patients on combined pills with no more than 50 micrograms of estrogen and, if possible, one of the newer "low dose" combined pills with only 30 or 35 micrograms of estrogen. Major studies have concluded that switching from higher doses to pills with 50 micrograms of estrogen cuts the blood clot risk substantially. Recent research suggests that pills with less than 50 micrograms of estrogen cut the risk even further. Progestogen levels in pills have also dropped over the years. Minipills contain even less progestogen than low-dose combined pills, which may make the minipill the safest oral contraceptive known. How they work. Combined birth-control pills, including the newer low-dose forms, work by suppressing ovulation, the release of an egg from the ovary. Without a released egg, pregnancy cannot occur. Though rare, it is possible for women using combined pills to ovulate. Then other mechanisms work to prevent pregnancy. Both kinds of pills make the cervical mucus thick and "inhospitable" to sperm, discouraging entry to the uterus. In addition, they make it difficult for a fertilized egg to implant, by causing changes in fallopian tube contractions and in the uterine fining. These actions explain why the minipill works, as it generally does not suppress ovulation. Effectiveness Taken properly, the combined pills are better than 99 percent effective. Some formulas with less estrogen may be slightly less effective, about 98 to 99 percent. Minipills are comparable in effectiveness to the IUD, at around 98 percent. But they must be taken without fail every day-ideally at the same time. Missing just one minipill can undo the contraceptive protection. Also, because minipills do not generally suppress ovulation, many doctors recommend a backup method, such as a diaphragm or condoms, at midcycle. Why Pills Fall If you take oral contraceptives, you should be prepared to use an additional form of birth control, because there are times the pill's effectiveness can be diminished. Skipping pills. This is probably the main reason for reduced effectiveness. Directions for what to do after missing a dose vary with the pill formula and are included in the package insert that comes with all pills. Using a backup method for the rest of the cycle (while continuing to take the pill) will in- crease protection from pregnancy. Illness. If you become sick with vomiting or diarrhea, your oral contraceptives may not be fully absorbed. It is safest to use an additional method for the rest of the cycle. Drug interaction. Some medications can diminish the pill's effectiveness, including certain antibiotics (rifampin, and perhaps ampicillin and tetracycline); epilepsy drugs (Dilantin); anti-inflammatory or antiarthritic drugs (phenylbutazone); and barbiturates (phenobarbital). If you are treated for any ailment, even one that seems totally unrelated to pill use, be sure to inform your physician if you take birth control pills. Should You Take the Pill? Many women are attracted by the advantages of the pill but are also concerned by the list of possible complications. Keep in mind that the process of weighing the benefits and risks is a highly individual one. No two women have exactly the same medical history or birth control needs. A doctor will help you make the best decision for you. For some women the pill is ruled out altogether. Using pills with estrogen is too risky for women who have had blood clots, heart attack, or stroke; chest pain caused by angina pectoris; known or suspected breast cancer or cancer of the uterine lining; undiagnosed abnormal vaginal bleeding (which may indicate cancer and must be checked out); liver tumors; or jaundice during pregnancy. Other health problems may also forbid pill use. These include fibroid uterine growths, diabetes, high cholesterol levels, high blood pressure, obesity, depression, gall bladder disease, and exposure to DES before birth. In addition, because the pill tends to cause the body to retain water, women with a history of migraine headaches, asthma, epilepsy, or kidney and heart diseases may find the pill worsens their condition. If they choose to take it, they must be monitored closely by their doctors. Cigarette smoking and age also add to the chances of a woman developing serious pill-related complications. But what about a woman without any of these risk factors? Once a woman's doctor has found that she has no detectable physical reason for avoiding the pill, the decision is in her hands. The pill carries a relatively small risk of serious complications even to the safest group of users-young, healthy nonsmokers. Therefore it is important that the decision be an informed one. Understanding the risks. The "patient leaflet" that comes with all pills contains a complete list of potential complications. Women should remember, though: o The pill affects all body cells, so the potential complications linked with it are many. But the chances of most young, healthy, nonsmoking women developing a particular complication are slim. o The most serious side effects are also the most rare. o Many of the risks known today were estimated through studies of older women using the higher dose pills. Therefore some experts believe that these studies may overstate the likelihood of complications in younger women using the newer low-dose pills or minipills. Estimated Annual Deaths per 100,000 Women Cause of Death Ages-15-19 20-24 25-29 30-34 35-39 40-44 childbirth 5 6 7 13 21 22 pill complications smokers 2 4 6 12 31 61 pill complications non-smokers 1 1 2 3 9 18 all causes including accidents 54 67 74 98 146 237 o Knowledge of the health risks associated with childbirth can help to place in perspective the problems associated with pill use. The chances of dying from a childbirth complication exceed the chances of dying from a pill complication, except for smoking pill users aged 35 and over. As shown in the chart above, in either event, death is very rare. (Many women die each year for other reasons, including accidents and other health problems, as shown by the overall death rate included below for comparison.) Other considerations: minor side effects. The pill also causes many minor side effects. Although they are not fife threatening, they are nuisances and many women stop taking the pill because of them. A minority of women on the pill experience nausea or vomiting (usually only in the first few cycles), weight changes, breast tenderness, abdominal cramps, or skin discoloration. Bladder and vaginal infections may also occur more frequently with pill use. In addition, some women report changes in sex drive (either increased or decreased), a loss of scalp hair, or an intolerance to contact lenses (because of water retention). Many of these complaints disappear after the first few cycles of pill use. They may occur less often with low-dose pills and minipills. The newer formulas, however, are more likely to cause menstrual irregularities, such as spotting, breakthrough bleeding (which should be reported to a doctor), or, rarely, a lack of periods altogether. Menstrual irregularities are much more common with minipills than with combined pills, but cycles often become regular with time. Knowing the benefits, too. The combined pill, when taken properly, is unmatched in effectiveness. And the pill in general allows more spontaneity in sexual relations than barrier methods that must be applied at the time of intercourse. These benefits have long been known. But we are now learning that the pill protects women from some relatively common and potentially serious disorders that have nothing to do with its use as a contraceptive. According to recent estimates, each year, the pill prevents: oo 51,000 cases of pelvic inflammatory disease, 13,300 of which would have required hospitalization, o 20,000 hospitalizations for certain types of noncancerous breast disease, o 9,900 hospitalizations for ectopic pregnancy, o 3,000 hospitalizations for ovarian cysts, o 27,000 cases of iron deficiency anemia, and o 2,700 cases of rheumatoid arthritis. The protection against pelvic inflammatory disease (PID) may be the most important noncontraceptive benefit of the pill. PID-A bacterial infection of the uterus, fallopian tubes, or ovaries-affects an estimated 850,000 U.S. women yearly. It can lead to infertility or, in rare cases, death. Studies have shown that women on the pill have half the chance of developing PID compared to women using no form of birth control. (Women using barrier devices also have half the chance.) Other advantages of the pill include less menstrual cramping, lighter blood flow, and for those using combined pills, very regular periods. Some women using oral contraceptives also have diminished premenstrual tension. And women with acne often find the pill improves their complexion. The Major Risk The most serious side effect of oral contraceptive use is an increased risk of cardiovascular disease-specifically blood clots, heart attacks, and strokes. But even these complications are occurring less frequently, according to Bruce Stadel, M.D. (NICHD), as a result of lower hormone content in pills, better screening of women who might be at high risk, and, perhaps most importantly, the recent drop in pill use among women over 35. What are the odds? Pill-related heart attacks are very rare. They occur in an estimated one in 14,000 users between the ages of 30 and 39. Between the ages of 40 and 44 the risk rises to about one case in 1,500 women on the pill. Strokes occur five times more frequently among women taking oral contraceptives. But they are a rare event, too, affecting about one in 2,700 women on the pill. Although clots in the veins occur more often than heart attacks or strokes, they are still uncommon, affecting about one in 500 previously healthy women on the pill. Hormone changes in pregnancy cause clots far more frequently than pills do. Who are the high-risk women? The vast majority of heart attacks and strokes among pill users occur in women who smoke, women over 35, and women with other health conditions, such as high blood pressure, that ordinarily con- tribute to cardiovascular risk. Women with a combination of two or more of these factors carry the greatest risk of all. (See "Compounding the Risks.") Some research shows that the length of pill use can affect the chances of having a cardiovascular complication. A recent study found that women aged 40 to 49 who had taken the pill for five or more years had twice the average heart attack risk-even years after they stopped taking the pill. Heavy smoking adds far more to the chances of having a heart attack, however. Perhaps surprisingly, age and smoking habits do not seem to increase the chances of developing blood clots in the veins. But women with certain blood types-A, B, or AB-are twice as likely to develop clots as women with type 0. This is true whether a woman is on the pill or not. NICHD-funded research has shown that women who experience clotting disorders may lack the ability to produce extra amounts of a certain anticlotting blood protein that women on the pill need. Unfortunately it is not yet possible to predict who will have this problem. But researchers have found evidence suggesting that women may counteract it through regular exercise, which may spur the body to produce more of the anticlotting protein. Because oral contraceptives double the chances of developing blood clots after surgery, doctors advise women taking the pill to stop, if possible, at least four weeks before any scheduled operation. And all women on the pill should know the symptoms that indicate a possible blood clot-sharp pain in the chest, coughing blood, or sudden shortness of breath; pain in the calf; or sudden partial or complete loss of vision-and notify their doctors immediately if they experience any of them. High blood pressure. Although many women experience a mild elevation in blood pressure when they are taking oral contraceptives, it usually remains within the normal range and returns to "prepill" levels when they stop. Studies several years ago found that pill users have three to six times the average risk of developing high blood pressure. It has been estimated to occur in one to four percent of women who take the pill and is usually confined to those over 35. Newer studies show that high blood pressure is not a common problem for today's younger pill takers. But all women on the pill should have their blood pressure checked every six to 12 months. Compounding the Risks Factors such as smoking, increasing age, or high blood pressure add to the chances of developing cardiovascular disorders-problems in the heart or blood vessels. Combine any of these factors with oral contraceptive use, and the risks multiply. And when a woman has more than one risk factor, her chances of a serious pill complication skyrocket. Smoking. Most of the women who have a heart attack or stroke while using the pill are smokers. The mechanism is not understood, but the pill somehow intensifies the adverse effects of smoking on the circulatory system. To illustrate: One study found that either using oral contraceptives or smoking increased the odds of having a stroke by about six times. In women who both smoked and took the pill, the risks did not just add together. Instead, they jumped to 22 times the risk of stroke in women who neither smoked nor took the pill. All smokers using the pill are at greater risk than nonsmokers. The likelihood of heart attack or stroke rises sharply for those who smoke more than 15 cigarettes per day. From the standpoint of safety, doctors now advise pill users not to just cut back, but to quit smoking altogether. Age. The natural aging process also increases the chances of developing cardiovascular disorders, and birth control pins accentuate the risk. An example: In women who don't use the pill, those aged 40 to 44 are about five times as likely to have a heart attack as those aged 30 to 39. But in pill users, the older age group is about nine times as likely to have a heart attack. The cardiovascular risks of the pill begin to rise substantially around age 30, particularly in smokers. However, there is no definite cutoff age for pill use. Some doctors believe that regardless of smoking habits, women should consider other forms of contraception starting at age 30. Others feel that at age 30, women who smoke and take the pill should choose between the two, while nonsmokers are relatively safe until age 35. Still others hold that the new low-dose pills and minipills may be safe options for women over 35 who do not smoke or have other unfavorable health conditions. Obviously, the final word is not yet in. Over the next few years, NICHD- supported studies should help clarify the pill's risks to women over 30. Health conditions. Women at any age with health problems that ordinarily increase the chances of cardiovascular disease are even more at risk when using the pill. The conditions include: ù high blood pressure, ù a history of high blood pressure in pregnancy, ù obesity, ù diabetes mellitus, and ù elevated cholesterol. Combined risk factors. When more than one of the above risk factors are present, the chances of a serious pill complication increase dramatically. A recent study found that the odds of having a heart attack are increased by: 3 times among pill users, 5 times among smokers, 8 times among people with high blood pressure, and 170 times among pill users with high blood pressure who smoke. An expert on oral contraceptives at the Centers for Disease Control (CDC), Dr. Howard Ory, stresses that "the most serious adverse effect of pill use- death from cardiovascular disease-is also the most preventable. " "If women who use the pill would not smoke,," he states, "at least half of all deaths associated with pill use could be avoided. If in addition, women with other predisposing factors for cardiovascular disease, such as high blood pressure, high cholesterol, and diabetes mellitus would not use the pill, deaths could be further reduced." The Pill and Cancer Probably the question women ask most frequently about oral contraceptives is, "Does the pill cause cancer?" Because most kinds of cancer take so long to develop, the answer must still be tentative, but it is reassuring: There is no firm evidence that the pill causes cancer. The NICHD and the CDC are currently cosponsoring a long-term project to analyze the pill's relationship to breast cancer and cancer of the reproductive tract. Although final results will not be available until the mid-1980's, the preliminary, results are encouraging, showing no association between the pill and breast cancer. Early results also suggest that women who have used the pill for at least one year have half the average risk of developing cancer of the ovary and of the endometrium (the fining of the uterus). No clear cause-and-effect relationship has been established between the pill and cancer of the cervix, but most doctors still feel it is very important for women on the pill to have yearly Pap smears. One kind of potentially life-threatening cell growth that is linked with the pill is an extremely rare liver tumor known as hepatic adenoma. Although it is not cancerous, it can cause internal bleeding. It occurs in about one in 33,000 pill users per year, mostly women who have taken the pill for about five years or more. Early detection of the condition can make a difference. Make sure that your checkups include a physical exam of the abdomen. The Pill and Body Chemistry Studies of women taking combined pills with at least 50 micrograms of estrogen show changes in the levels of sugars, fats and proteins in the blood, and alterations in the way the body uses certain nutrients. These and other metabolic changes can cause slightly altered thyroid, Ever and blood tests, though results usually remain within the normal range. While it appears that metabolic changes are lessened with the newer formulas, the long-range effects of even small changes in body chemistry in pill users are unknown. Current studies supported by the NICHD are expected to define these changes more precisely and to determine whether they affect the risk of cardiovascular disease in pill users. Nutritional changes. Oral contraceptives can affect nutritional status, but studies of this topic often have conflicting results. This is because many variables, such as hormone shifts throughout a menstrual cycle, can also change the body's nutritional needs. In women taking the combined pill, studies have found increased levels of vitamin A and iron; decreased levels of vitamins B-6, B-12, C, and riboflavin; and both increases and decreases in levels of folic acid and zinc. A lowered level of vitamin B-6 is the most consistently reported nutritional change in pill users. One NICHD funded study found that lowered levels of B- 6 during pregnancy and lactation were more common in women who used the pill for a long time (more than 30 months), and became pregnant within four months after stopping the pin. Nevertheless, it is uncertain whether pill use is a cause of true vitamin B-6 deficiency, which is linked with depression (see next page). Other symptoms of vitamin deficiency include weakness, lethargy, dizziness, skin and gum irritations, and an increased susceptibility to infection. Next to vitamin B-6, folic acid is the nutrient most significantly affected by the pill. Changes in folic acid metabolism have been reported in connection with two conditions in pill users. A few women using oral contraceptives have developed a rare but serious anemia which responds to treatment with folic acid supplements. In addition, the pill is linked with changes in folic acid metabolism in cells around the cervix, which may be related to a kind of abnormal cell growth called cervical dysplasia. An NICHD-supported study found that cervical dysplasia sometimes improves with folic acid supplements. For pill users, a balanced diet is often recommended over routine vitamin and mineral supplements for two reasons. First, overdosing on supplements can be toxic, and second, people taking supplements often do not try as hard to get a balanced diet. Vitamin supplements cannot take the place of a balanced diet; in fact, they need to have proper foods present to work right. But when medical tests show a vitamin deficiency, vitamin supplement therapy may be in order. Recent studies on oral contraceptives and metabolism found that pill users do not eliminate caffeine or valium as efficiently as nonusers. This means that either substance can accumulate in the body. As a result, women using the pill may be more prone to caffeine side effects such as nervousness and insomnia. Those using valium could become oversedated if the dosage is not carefully watched. Depression Oral contraceptives alleviate depression in some women and worsen it in others. Symptoms of depression related to pill use include pessimism, dissatisfaction, listlessness, tension, crying, and perhaps anxiety or a loss of sex drive. Although many of the reports of pill-related depression came when higher doses of estrogen were widely used, it is not clear whether depression is less common with the newer low-dose pills or minipills. Depression can be a symptom of vitamin B-6 deficiency. The pill can affect the body's use of B-6 and other vitamins and minerals, and studies have found that some depressed pill users are B-6 deficient. These women may respond to vitamin B-6 therapy. Women who become seriously depressed while on the pill should discuss it with their physicians, and consider switching to another form of birth control. The Pill and Childbearing Many women taking birth control pills are planning to have children at some time. For them the news is good: There appears to be little risk that use of the pill leads to sterility. In fact, because the pill protects many women from pelvic inflammatory disease, which can damage the fallopian tubes, it guards against a leading cause of infertility. Fertility. Former pill users may take a few months longer to conceive than other women, but an estimated 80 percent of women resume normal reproductive functions within three months after stopping the pill and more than 95 percent are ovulating within a year. Women, who do not regain normal periods within six months should see a doctor for a complete evaluation. Most women who have menstrual problems after stopping the pill had irregular periods before they started taking it. But some studies suggest that there is a very slim chance that the pill itself causes a condition known as "post-pill amenorrhea"-a lack of periods. Though the cause of the problem is a matter of much debate among researchers, infertility after stopping the pill generally is temporary and responds to treatment. Pregnancy. Many doctors recommend that women who wish to become pregnant use traditional barrier contraceptives for at least three months after stopping the pill. Usually, a woman's menstrual cycle will become regular during this time, which permits the doctor to accurately date the start of the pregnancy. When former pill users do become pregnant, they have no greater risk of complications than other women. Although it happens extremely rarely, oral contraceptives can fail even when a woman has been conscientious about taking them every day. In addition to causing an unplanned pregnancy, pill failure can lead to inadvertent exposure of a developing fetus to extra hormones. Some studies show a slight increased risk of birth defects in infants exposed before birth to oral contraceptive hormones; other studies have found no risk. Experts generally agree that the risks, if they exist at all, are very small. But for absolute safety, if you even suspect you might be pregnant, immediately stop taking the pill, switch to another form of contraception, and have a pregnancy test as soon as possible. Studies have shown no added risk of birth defects when conception occurs one month after stopping the pill. Breastfeeding. Physicians often recommend methods other than the pill for women who are nursing babies. For one thing, the estrogen in combined pills can suppress milk production. Also, very small quantities of hormones pass from the mother to her nursing infant. Although no long-term effects of this ingestion have been reported, the possibility of risk to the baby has not been extensively studied. For women who want to breastfeed and use an oral contraceptive, doctors frequently suggest the minipill, since it does not suppress lactation. How to Minimize the Risks Both doctors and the women for whom they prescribe birth control pills have a role in reducing the chances of pill-related complications. Doctors must screen patients carefully, follow up conscientiously, and prescribe the lowest possible dose that is compatible with an individual woman's needs. Yet as recently as 1978, one-fourth of the women taking the pill in the United States were still using formulas with more than 50 micrograms of estrogen. Check your prescription: If it contains more than 50 micrograms, you might ask your physician if you can try a lower dose. Women must be open with their doctors, informing them of any health problems. They must also know the signs that indicate a possibly serious complication of pill use and call their doctors immediately (see next page). In addition, women on the pill should exercise regularly. Above all, they should have medical checkups at least yearly (more frequently if their doctors advise). Twenty years ago there was hope that the pill would prove to be the perfect form of birth control: effective, convenient, and safe for all women. Ten years ago reports of side effects brought disillusionment. Today we know that the pill, though imperfect, is an option many women can use safely. We now have better formulas, better screening of women, and a better informed public. And as these trends continue we can look forward to even safer use of the pill. Warning Signals Women taking oral contraceptives should be alert to any physical or mental change that may warrant a visit to the doctor. If you experience any of the following symptoms, notify your physician at once and remind him or her that you are on the pill. * Severe abdominal pain * Chest pain, coughing, shortness of breath * Pain or tenderness in calf or thigh * Severe headache, dizziness, or faintness * Muscle weakness or numbness * Speech disturbance * Eye problems: blurred vision, flashing lights, blindness * Breast lump * Severe depression * Yellowing of skin "Facts About Oral Contraceptives" was written by Maureen B. Gardner, Office of Research Reporting, National Institute of Child Health and Human Development (NICHD). It is reprinted from the June 1983 issue of Good Housekeeping magazine with permission of the publisher. The NICHD, part of the Federal Government's National Institutes of Health, conducts and supports research on the various processes that determine the health of children, adults, families and populations. For more copies of this fact sheet or others in this series, write to NICHD, P.O. Box 29111, Washington, D.C. 20040. Other Publications in This Series: Facts About Anorexia Nervosa Facts About Cesarean Childbirth Facts About Childhood Hyperactivity Facts About Down Syndrome Facts About Dyslexia Facts About Dysmenorrhea and Premenstrual Syndrome Facts About Precocious Puberty Facts About Pregnancy and Smoking Facts About Premature Birth Facts About Vasectomy Safet