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Drug Labeling with Pregnancy in Mind

When you're pregnant, or thinking about getting pregnant, there are so many things to consider: Are you ready emotionally? Financially? Physically?

Once you've addressed those issues, many other important questions remain -- including this one: Are your prescription drugs safe for you to take while you're pregnant?

The U.S. Food and Drug Administration has been working for more than a decade to make that question easier for women and their doctors to answer. Late last week the agency took another step in that process, proposing new drug-labeling guidelines that aim to more clearly and thoroughly spell out a drug's potential risks and benefits to a pregnant or nursing mother and her baby.

The new system would require drug labels to provide three categories of information:

* a "Fetal Risk Summary," telling what's known about a drug's effect on a fetus;

* "Clinical Considerations," listing what's known about the drug's effects if it is taken before a woman knows she is pregnant. This section would also discuss dosing, complications and risks to the mother and the baby of non-treatment;

* "Data," providing detailed information about the data on which the Fetal Risk Summary is based. This section would also address whether a "pregnancy exposure registry" exists - a venue for collecting further data on use of the drug during pregnancy.

The new label requirements would replace the current system under which drugs are assigned a letter (A, B, C, D or X) indicating their relative safety. (That system is clearly explained here.) Some consumers found that way of categorizing drugs confusing and inflexible, and it didn't allow for much nuance.

Interested parties have 90 days to comment on the proposal. Assuming no major obstacles, FDA approval of the measure is expected within a year. Once that occurs, makers of new drugs will have to update their labels immediately. Makers of older drugs will have more time to phase in label changes.

But new system or not, making decisions about taking meds while you're pregnant or nursing isn't likely to become clear-cut anytime soon. Weighing whether the possible risks of a drug outweigh its likely benefits won't always be easy: In many cases, such as when a woman takes medications for asthma, depression, or diabetes, it may well be in a woman's best interest to stay on those meds while pregnant, even if it's uncertain how those drugs may affect her baby. But at least women and their doctors will have the best-available information right in front of them.

I wasn't diagnosed with multiple sclerosis until long after my babies were born and had stopped nursing, so I didn't have to decide whether to stop the drug I take every day to keep my disease in check. Thank goodness for that, because not much is known about how the drug affects pregnant women or their babies.

How about you? Have you had to make a decision about taking prescription drugs while you were pregnant or nursing? How did you go about making that decision?

By Jennifer LaRue Huget  |  June 2, 2008; 7:00 AM ET
Categories:  Family Health  
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