The Pill: 30 Years of Safety Concerns

By Snider, Sharon | FDA Consumer, December 1990 | Go to article overview

The Pill: 30 Years of Safety Concerns


Snider, Sharon, FDA Consumer


The Pill 30 Years of Safety Concerns

When the birth control pill was introduced in 1960, it was a major medical achievement that rewrote the future of women and family life. For the first time in history, it became possible for a woman to safely and effectively control childbearing by taking a pill.

This year "the pill," as it is commonly referred to, is celebrating its 30th anniversary. Since its introduction, it has been used by more than 60 million women worldwide. It has proved to be, in the opinion of many, the most socially significant medical advance of the century.

American women were quick to accept the pill. Within two years, approximately 1.2 million women were using it, within five years, 5 million, and by 1973, about 10 million. In the early '80s, following reports of possible harmful side effects, use of the pill dropped to 8.4 million. Today, however, with safer, low-dose versions on the market, use is back up. Approximately 10.7 million American women now use the pill. It is the most popular method of non-surgical contraception.

Concerns about side effects have dogged the pill over the years. And rightly so. Doe the pill presented society with problems unique in the history of medicine. As an FDA advisory committee on the pill noted in the mid '60s, never would so many people take such a potent drug voluntarily over such a long period for a reason other than to cure disease.

"Since probably no substance, even common table salt, and certainly no effective drug, can be taken over a long period of time without some risk," the advisory committee warned, the pill's potential side effects "must be recognized and kept under continual surveillance."

Oral contraceptives have been kept under surveillance for 30 years. In fact, over the years, more studies have been done on the pill to look for serious side effects than have been done on any other medicine in history, according to FDA.

Fears about blood clots, heart attack, and stroke, which spurred exhaustive research on oral contraceptives in the '60s and '70s, have largely been laid to rest by the safer, low-dose birth control pills on the market today. Current research suggests that healthy, non-smoking women have little if any greater risk of these serious health problems than do women who do not use the pill.

Questions about the pill's association with cancer, however, remain. Some widely reported recent studies support the hypothesis that in certain groups of women the risk of breast cancer increases with oral contraceptive use. A larger number of studies, however, found no significant increased risk. Nor is it definitely known yet whether or not the pill causes cervical cancer in some groups of women. So far, a cause-and-effect relationship has not been established.

But the pill has been found to help prevent two major types of cancer--cancer of the ovaries and cancer of the endometrium (the lining of the uterus).

Last December, an FDA advisory committee, reviewing the relative risks and benefits of today's birth control pills, recommended that the upper age limit of 40 then in use for the pill be lifted for healthy, non-smoking women, thereby making this popular, effective means of contraception available until menopause.

How the Pill Was Developed

It was 1950 when Dr. Gregory Pincus, an American biologist, was invited by the Planned Parenthood Federation of America to develop an ideal contraceptive--one that Planned Parenthood stipulated would be "harmless, entirely reliable, simple, practical, universally applicable and aesthetically satisfactory to both husband and wife."

Planned Parenthood donated $2,100 to the project. Another $20,000 to $30,000 had to be raised from government and private sources before research could get under way.

Within a few years, an oral contraceptive was being clinically tested in 6,000 women in Puerto Rico and Haiti. …

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