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The Food and Drug Administration has recently concluded to improve the labeling of medicines to provide clear and comprehensive information regarding effects during pregnancy and breastfeeding. This recent change is in contrast to an existing system that ranks medicines using five letters which are not often clear to consumers. It has become a higher priority for the FDA to address the needs of pregnant and breastfeeding women.
Why are Labeling Guidelines Changing?
According to the FDA, there a variety of reasons that is important to clearly communicate drug facts to pregnant women. Currently, most women take at least one medication while pregnant, and the use of four or more medications during pregnancy has doubled over the last 30 years. Additionally, many pregnant women suffer from chronic conditions that require medication like diabetes, depression, high blood pressure, and respiratory disease which can also worsen during pregnancy.
What is Changing?
The new labeling information will provide sections specifically addressing those that are pregnant or breastfeeding. These sections will clearly identify any risk to mother and/or child. Additionally, these labels will provide information regarding contact centers in case of exposure that will maintain data regarding usage and effects. These labels are also expected to include a subsection targeted to Females and Males of Reproductive Potential to identify anything relevant to family planning, fertility, birth control, and pregnancy testing.