Birth Control Pill Safety Concerns : Part 3

by Food and Drug Administration (FDA)

(Page 3 of 3)

Today's Pill Safer

Today's oral contraceptives are considerably safer than the pill of the '60s because they contain less estrogen and progestin. Over the years, the amount of estrogen has been reduced to one-third or less of that in the first birth control pills, and the progestin has been decreased to one-tenth or less.

The risks of blood clots, heart attacks, and stroke have decreased correspondingly for healthy, non-smoking women. There is a slightly increased risk of cardiovascular disease for women over 40 who use the pill, but the benefits of contraception are considered to outweigh the risk in most women, says Philip Corfman, M.D., of FDA's division of metabolism and endocrine drug products.

Most side effects of the pill are not medically serious. The most common are nausea, breakthrough bleeding (bleeding between menstrual periods), and mood changes, including depression. Some women may also experience weight gain, breast tenderness, and difficulty wearing contact lenses due to eye dryness. These side effects, especially nausea, usually subside within the first three months of use.

Health Benefits

In addition to its contraceptive effectiveness, the pill has proven to have significant health benefits. Studies show that the incidence of ovarian and endometrial cancers, benign cysts of the ovaries and breasts, and pelvic inflammatory disease decreases with pill use. The pill also prevents heavy and irregular menstrual periods, a common cause of anemia that leads to surgical procedures, including hysterectomy, in older women.

Whether these benefits will continue with the newer, low-dose pill remains to be seen. The present benefits are associated with oral contraceptives containing 50 mcg of estrogen. As yet, no scientific data are available on the effects of those containing 30 to 35 mcg or less.

Not Safe for All

As safe as today's pill is for most healthy, non-smoking women, it is still not safe for all women. The risk of serious illness and death increases significantly for certain groups:

Women who smoke — particularly those over 35 who are heavy smokers (more than 14 cigarettes a day) — have a significantly increased risk of heart attack and stroke. This risk increases with age. Women who use oral contraceptives are strongly advised not to smoke.

Women who are obese or have underlying health problems, such as diabetes, high blood pressure, or high cholesterol, also have a significantly increased risk of serious side effects from using the pill.

Women who have a history of blood clots, heart attack, stroke, liver disease, or cancer of the breast or sex organs should not use oral contraceptives.

Women who become pregnant while on the pill should immediately discontinue taking it because of a risk of birth defects in the child.

Uncertainties remain about whether the pill causes breast or cervical cancer in some groups of women. Despite many studies over the years, there is still insufficient evidence to definitely rule out these possibilities.

While there are conflicting results among studies on breast cancer and the pill, most investigations have found that women who have taken the pill have no increased risk of developing breast cancer. However, the product labeling on oral contraceptives recommends that women who use the pill and have a strong family history of breast cancer or who have breast lumps or abnormal mammograms be closely monitored by their doctors.

Some studies have found an increase in the incidence of cervical cancer in women who use the pill, but this may not necessarily be related to the pill, scientists say.

One of the major problems of the studies to date, says Corfman, is that all the data reflect the effects of the higher-dose pills (those containing more than 50 mcg of estrogen). No studies have been done on the low-dose pills, and none are under way. The cancer-pill issue is very complicated and therefore difficult to study, and the research is expensive, he says.

"We really need another breast cancer study on the low-dose pills," Corfman says. "We have the capability of finding out about breast cancer, but no one is doing the research."

Researchers may never find out whether the pill causes cancer of the cervix, Corfman says, because the development of cervical cancer can be affected by numerous other factors, such as the age a woman begins having sex and the number of sexual partners. Corfman says he suspects, however, that such research would show that the risk of getting cervical cancer from the pill is so small as to be outweighed by the benefits of contraception.

Though some safety questions remain unsettled, for most healthy women the pill provides a safe, effective means of birth control with some possible beneficial health effects.

About the Author

www.fda.gov
FDA is A United States government body that oversees medical devices, including contact lenses, intraocular lenses, excimer lasers and eyedrops. In the US, these products must be approved by the FDA before they can be marketed.