Pregnancy labels for medicine?
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The Federal Drug Administration is proposing a change to the way medicines are labeled with warnings for pregnant women. Doctors have been complaining forever that data was available that was not included on labels or that the information that was presented was confusing. Personally, I couldn't agree more. I am an admitted nervous nelly when it comes to being pregnant and worrying about harming my unborn child, so any additional information about the effects of something on my unborn child or breastfed child would be very helpful, and possibly ease my anxieties (oh, who am I kidding? We all know I'd be terrified to take the medicine anyway!)
Currently, the system is a series of categories that describe the level of harmfulness to a fetus. Category "A" on a label means no studies have turned up harmful effects, while an "X" means a substance should not be consumed or used during pregnancy. That seems relatively simple. The in between letters and categories, though, signify things like no data available or that there are conflicting results about possible harm. The new system would, in theory, would have three summaries on it, to include information about risk to the fetus, risk to the mother (from the disease) and the previously missing supporting data. Additional information would be provided regarding possible effects on breastfed infants.That sounds like a lot of reading!
According to the FDA, there are nearly 6 million pregnancies in the US each year, and pregnant women take an average of three to five prescriptions during pregnancy. That seems awfully high, but perhaps those numbers include prenatal vitamins. The new plan has the support of the March of Dimes, whose mission is to reduce birth defects. The president of the National Research Center for Women & Families also supports the change, but notes the new labeling system will be useless until proper research is done to prove which medicines are safe or risky for pregnant or nursing women.
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