The Food and Drug Administration (FDA) will change its drug labeling regulations for informing pregnant mothers on June 30, 2015. The hope is that the new labeling system will reduce the chances of misuse of medication and cut down on both birth defects and the pharmaceutical litigation that can result from failing to inform patients of drug toxicity to newborns.
What is Wrong With the Current Drug Label System?
The system that will be replaced has had faults in its history. For instance, a 1992 study by the Teratology Society found that the Category System, as the current system is called, led to many terminated wanted pregnancies, which had been ended only because of the fear of a birth defect. It turns out that many of these were unnecessary, but that the labeling of X, C or D on a drug label misled mothers into thinking that the drug may guarantee a serious birth defect.
A and B class drugs pose no or little risk to children. Drugs labeled C class are untested and, therefore, have an unknown risk. D class drugs are medication that have posed a risk in the past or have been shown to pose a risk through experimentation. An X class drug means that it can cause birth defects and that it should not be used during pregnancy.
According to Lamaze International, an organization for parents or future parents, about 90 percent of new drugs are labeled C, D or X. The C label is used most often, which means the drug has not been tested for toxicity to newborns. Clearly, this is not a helpful label.
How Will the New Rules Change Drug Labels?
The following alterations to the current rules could lead to more children born without medicinally caused birth defects:
- Labels must be upgraded to show any risk changes due to new studies.
- Manufacturers must provide better and more various ways of detailing the risks of a drug.
- The pregnancy categories of A, B, C, D and X will be removed. The labels will provide information in three categories: Pregnancy (including labor and deliver), Lactation (including nursing mothers) and Females and Males of Reproductive Potential. The latter category is entirely new to these drug labels.
Perhaps the new labeling system will better protect you and your child from bad medicine. However, this will not prevent nor protect pharmaceutical companies that have acted in a negligent manner. If your child’s birth defect was caused by medication, then you may have grounds for a lawsuit.
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Farrell & Patel – Birth Injury Lawyers
Source: http://www.fda.gov/Drugs/DevelopmentApprovalProcess/DevelopmentResources/Labeling/ucm093307.htm
