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New FDA Prescription Drug Labeling Changes

December 05, 2014

The FDA announced on December 3, 2014 that prescription labels will be required to have additional important information about the effects of the medicine during pregnancy. These changes will go into effect over the next couple of years starting in June 2015 and they will provide more accurate information. The current labeling system is very outdated and there is a lot of important information that should be on these labels that is not.

These new label requirement rules are referred to by the FDA as the “Pregnancy and Lactation Labeling Rule”.

This info is essential for pregnant women and their doctors, currently women take an average of 3 different medications when they are pregnant. Since many of these women are taking medications during pregnancy because of a medical issue, they deserve to know of any potential problems that could arise from them.

The new medicinal labeling requirements will include better information about side effects of the specific medication, such as if it gets into breast milk, and if it can affect an infant while breastfeeding. These new labels will also include a section that will tell you if the medication can interfere with pregnancy testing, birth control, and if a medication can have an effect on fertility.

The new label requirements do not apply to any over the counter medicines.

Medicinal Labeling History

The FDA had previously (and currently) categorized the risks of taking pharmaceuticals and biological products during pregnancy with a letter system (A - D, X), and this was based on known information about the medicine. Over the years the FDA received numerous complaints about how confusing this system was, and how many problems it had caused because of the confusion the labels have caused.

New labeling requirements will make this system much less confusing. Both women and their doctors will now get to know much more about how a specific medication can affect them and their infant child.

The New Labels

These new medicine labels will throw out the outdated lettering system, and instead, the label will provide more helpful information about the medication's risk to both mother and child. These new labels will also have contact information for women that will allow them to easily reach out to a pregnancy exposure registry that will compile and analyze information on the effects of medications used by significant women.

Preparing for the Change

The new labeling regulations for prescription drugs and biological products goes into effect on June 30, 2015, so any new products approved after that date will need to adopt the new requirements right away. Labeling that was approved between the last label requirement changes on June 30, 2001 up until June 30, 2015 will be able to phase in these new labels gradually.

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