Originally published on September 5, 2012, on bedsider.org
Any prescription birth control method you buy in the United States comes with a square of delicately thin paper, folded until it won’t fold any more, covered in teeny-tiny print. It’s called a “package insert” or a “label”—and it may be telling you lies.
First, some history…
It wasn’t so long ago that there was no such thing as a drug label. In the 1950s, people used prescription drugs after merely talking with their doctors. Faith in medicine was high, thanks to new and amazing drugs like antibiotics. In general, there were fewer drugs, and fewer people had ailments that required years of continuous medication. New drugs were approved by the U.S. Food and Drug Administration (FDA) after manufacturers proved they were safe; there was no formal requirement to prove they worked.
In 1957, the birth control pill came to the U.S. The FDA first approved it to treat “menstrual disorders”—which tens of thousands of women suddenly developed. When the maker of the pill applied to the FDA to allow women to use it as a contraceptive, the FDA dragged its feet. In 1960, the FDA finally approved the pill for contraception, but only for two years of use. It was the first modern birth control method and the first hormonal medication taken by healthy people. Around the same time, Congress required makers of drugs to prove to the FDA not only that a drug is safe, but that it works as advertised.
Over the decade that followed approval of the birth control pill, hundreds of thousands of U.S. women started using it. Early versions of the pill had much higher doses of hormones in them, and some women had serious side effects as a result. Reports of problems with the pill always made sexy headlines (still do). Eventually, in 1970, the controversy about the safety of the pill got so heated that Congress called for a hearing about it. Women’s health activists attending the mostly-male hearing (sound familiar?) demanded that the risks of the pill be spelled out for any potential user to read in black and white. They argued that women using the pill in the last decade hadn’t been adequately warned of the potential side effects. So the label was invented for the pill, and now all prescription drugs are required to carry one.
Why so dense?
Labels are designed mainly for doctors to stay in the know about the medicines they prescribe, so they have always used intense doctor-speak. In the 1980s, labels got even more complicated, partly because lawyers started using them as evidence in cases against drug manufacturers. To protect themselves from lawsuits, drug makers added all kinds of hypothetical risks and problems to labels—even when there was little proof that the medicine actually caused the problem. In an effort to simplify, the FDA came up with a new label format. All medicines approved after 2001 are required to include highlights and a table of contents on their label. The FDA also helpfully required that all labels be printed in at least 6 point font.
Black box warnings
Sometimes a label has a box right at the top, outlined in black. It’s called a “black box warning,” and it is there to draw attention to an especially serious side effect or potential reaction to a medication. All black box warnings on birth control describe risks that came to light after the methods were approved—the FDA uses the black box to make sure everybody knows about it. Learning about some risks of a medicine many years later is not unusual, since to learn about very rare risks, millions of people have to use it. Methods with black box warnings include the shot, the patch, and some pills containing the progestin drospirenone (like Yaz, Yasmin,Beyaz, Safyral, and their generic versions).