Perhaps the result of recent criticism regarding the handling of the plastic baby bottle safety issue, the Food and Drug Administration (FDA) stepped up its game last week. First proposed was a mandatory drug safety labeling for pregnant and breastfeeding women. The FDA also issued a new position statement regarding the use of mercury dental fillings by pregnant women and children.
The FDA proposed a serious change in the labeling of both prescription and over the counter drugs. The labeling change would require safety instructions for pregnant and nursing women. Expecting U.S. women take, on average, 3-5 medications throughout pregnancy while 90% of breastfeeding women take medications during the first week after delivery.
In the works for 11 years, the new labeling system would provide data on testing as well as current research regarding risks for the medication. Information would be classified in 3 categories:
- Clinical considerations: the drugs possible effects if a women takes it before realizing she is pregnant
- Fetal risk summary: labels would detail known risks and whether those risks were determined via animal or human studies
- Data: current research information
Labeling would also indicate if expecting women need to alter the recommended dosage and provide information on the risk of birth defects while giving a better explanation of risks and side effects as they pertain to pregnant women and their unborn babies. The new labeling system also puts the responsibility on the drug makers requiring companies to regularly update information. Changing labels is rather costly for drug makers, but if the proposal goes into effect, all new drugs are required to abide by the new principals. Existing medications on the market will have 5 years to change their labels. FDA officials would like to make a final ruling within six months, while the proposal is open for public comment for 90 days.
It appears to have been a busy week for the FDA, as they also updated their consumer advice regarding the use of mercury amalgam fillings stating mercury poses a risk to fetuses, children, and expecting women. These particularly sensitive populations are at a greater risk for the side effects of mercury including neurotoxic effects on developing nervous systems. The statement comes shortly after the non-profit group Moms against Mercury won a lawsuit brought against the FDA for not warning mothers of the risks of mercury dental fillings forcing them to provide a public advisory. Also to be included in the FDA’s new mercury position statement is use of mercury fillings for those who are sensitive to heavy metals and persons with compromised immune systems.
Tags: pregnancy
This entry was posted
on Tuesday, June 10th, 2008 at 1:55 pm and is filed under Baby Safety.
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