reproduction

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Opinion: New Pregnancy Drug Guidelines A Mixed Bag For Consumers

pumicehead/flickr

pumicehead/flickr

By Dr. Adam Urato
Guest Contributor

Last week the Food and Drug Administration published a final rule that will change how drug companies present information on the risks of medications during pregnancy. This is considered a very important step as there are approximately 6 million pregnancies in the U.S. every year and the average pregnant woman takes between three and five prescription drugs during the course of a pregnancy.

For decades, the public has relied on the FDA’s Letter Category system in which a Category A drug was considered safe, Category D unsafe, with B and C falling in between, and Category X meaning contraindicated in pregnancy.

This past week the FDA announced that it is scrapping that letter system and replacing it with a new system that will offer descriptions about the effects of the drug during pregnancy and lactation. A third section (the “Females and Males of Reproductive Potential” subsection) will include information about pregnancy testing, contraception and about infertility as it relates to the drug.

So what exactly does all this mean for consumers?

As a Maternal-Fetal Medicine specialist, here’s my read on the changes:

What this means is that men and women are going to have to actually go to the drug information label and read it. No longer will a pregnant woman simply be able to look up a drug and find out that it’s a Category D in pregnancy, for instance, and then avoid it.

And this is a major problem that I see with the new system: many patients and physicians do not take the time to read through the label prior to using a medication. A description-based system risks losing the benefit of warning that the current Letter System provides when the drug is simply listed as Category D or X.

Also, it seems that the drug companies themselves are going to be asked to write these pregnancy sections on the label. This strikes me as absurd. Continue reading

10 Ways The Birds And The Bees Have Changed

(Courtesy Candlewick Press)

(Courtesy Candlewick Press)

Way back in 1988, children’s book author Robie H. Harris was sitting in a New York editor’s office batting around ideas for possible books. The editor proposed that she write a book about AIDS for elementary school children; she counter-proposed an all-encompassing look at “almost every single question that kids might have” about anything related to sex.

She rattled off a list of topics, and the rest is history: “It’s Perfectly Normal” is just out in its 20th-anniversary edition, with more than a million copies already in print. The mix of text by Harris and illustrations by Michael Emberley do indeed seem to cover all the sexual topics pubescent kids wonder about, from masturbation to menstruation to orientation to contraception.

“Of course,” Harris says, “over the years, I’ve added more topics as the times have changed, as information has changed, and as kids coming into puberty and adolescence have changed in some ways.”

What might those topics be? And what do they say about how kids’ worlds have changed over the last 20 years? Herewith, 10 significant changes in the book and what Harris says about them:

1. The Infosphere:
“There can be a lot of inappropriate, weird, confusing, uncomfortable, creepy, scary or even dangerous websites that you can end up on when looking for information.”

The biggest change in kids’ lives over the last 20 years, Harris says, is how they get their information. “With the explosion of information happening everywhere, kids are bombarded by sexual images, sexual words, words in songs. And then there’s the Internet: Kids can go on the Internet and find responsible information, and they can also go on the Internet and find information that is not accurate and sometimes absolutely dishonest.“

“And so the biggest change is the need to help kids know how to understand the information you get, and how do you get help with it? That’s when you go to a trusted adult. There’s just much more information to sort through for kids, and that’s why the biggest expansion in the book is the Internet chapter.”

And just a note on porn: Harris says every mental health expert she consulted says youngsters should stay away from it. (The book is for age 10 and up.) So “It’s one of the few judgments I put into the book, because I think it has to do with the health and wellbeing of our kids.”

2. Gender
“Gender is another word for whether a person is male or female. Gender is also about the thoughts and feelings a person has about being a female or being a male.”

Author Robie H. Harris (Courtesy Candlewick Press)

Author Robie H. Harris (Courtesy Candlewick Press)

That’s the broader definition of gender in the opening chapter, and the new edition also includes an explanation of “transgender” and “LGBT.” Harris acknowledges that the section on transgender youth “should have been in the book earlier, but it’s in there now.”

The section also includes a discussion of some people’s disrespect for gay and transgender people, and says it generally stems from ignorance. “I can’t write without a point of view,” Harris says. And her litmus tests has always been, “Is this what I would say to my own children?”

3. Long-acting birth control
The IUD, the implant and Depo-Provera are the most effective kinds of birth control.

The ranking of the most effective birth control methods is new, Harris says. It reflects a strong consensus among medical authorities that those long-acting methods are appropriate for teens who become sexually active — and desirable because they’re by far the most effective: they require no further action by the user — no daily pill, no pause for diaphragm insertion. Continue reading

Sperm Bank: No Red-Headed Men Need Apply

There’s been interesting coverage lately of sperm “super-donors” who father dozens of children, from this story in The New York Times to this one in the Boston Globe.

As co-author of a book that featured donated sperm, I can tell you that the prospect of dozens of half-siblings who could conceivably meet, fall in love with each other and unknowingly commit incest strikes a deep, atavistic chord in many people. At readings and events, it was one of the most common questions: “You mean there are no controls on how many children a donor fathers?”

Personally, it doesn’t worry me much. It’s a problem that could be solved by a national registry of donor-conceived children, and is already partly solved by the heroic efforts of a Colorado force of nature named Wendy Kramer, whose Donor Sibling Registry helps such half-siblings identify each other.

But here’s a true sperm-related outrage: Discrimination against red-headed men! Sisters, where is your discernment? Hat-tip to Beth Jones, who pointed out this article in the New York Daily News. Headline: “World’s biggest sperm bank, Cryos, tells redheads: We don’t want your semen.”

“There are too many redheads in relation to demand,” Ole Schou, the director of Cryos, told the Danish newspaper, Ekstrabladetaccording to London’s Telegraph.

Men with scarlett manes sell “like hot cakes” in Ireland, Schou said, but that’s about it. Continue reading