START A PETITION 25,136,189 members: the world's largest community for good
START A PETITION
x

Truth & Lies of Birth Control Labels

  • 1 of 3
Truth & Lies of Birth Control Labels

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 shotthe patch, and some pills containing the progestin drospirenone (like YazYasmin,BeyazSafyral, and their generic versions).

  • 1 of 3

Read more: Health, Life, Love, Relationships, Sex, Sexual Health, Women's Health,

have you shared this story yet?

go ahead, give it a little love

Bedsider

Everyone should have the life they want, when they want it. And until someone is ready to have a baby, we believe they should have access to birth control. That’s where we come in. Bedsider makes birth control easier. How? By giving you everything you need to find it, get it, and use it well.

40 comments

+ add your own
1:28AM PST on Dec 6, 2012

Hang on a moment!
" risks for the riskiest methods are still really small, especially compared to the risks that come with pregnancy."
Birth control is a lot more risky than pregnancy. It is extremely for a woman to die in the west from a pregnancy related complication, but every year women die because of the pill, even in my little country of NZ, 6-8 women die every year because of birth control side effects.

5:33PM PST on Dec 1, 2012

Next.

11:19AM PST on Nov 14, 2012

Thanks

11:01AM PST on Nov 14, 2012

Thanks for sharing

4:18PM PST on Nov 13, 2012

Thanks for sharing!

5:39AM PST on Nov 13, 2012

Thanks for sharing!

1:18AM PST on Nov 13, 2012

Interesting. Thank you for posting it.

7:37PM PST on Nov 12, 2012

The FDA’s [new] job is make sure Big Pharma makes money.

12:04PM PST on Nov 12, 2012

OMG

8:28PM PST on Nov 11, 2012

insufficient info 3 pages too long

add your comment



Disclaimer: The views expressed above are solely those of the author and may not reflect those of
Care2, Inc., its employees or advertisers.

people are talking

Very sweet! *_*

Paul L. comment is too funny and so true....if you're dates honey boo-boo. If someone ever gave me…

*Percentage of vaccinated individuals who fell ill: 2% Percentage of unvaccinated individuals who f…

Story idea? Want to blog? Contact the editors!



Select names from your address book   |   Help
   

We hate spam. We do not sell or share the email addresses you provide.