FDA Plans New Prescription Label for Pregnancy Risks

By Rheingold Giuffra Ruffo & Plotkin LLP

The FDA announced it is going to require new prescription medication labeling to clarify risks to pregnancy. The Chicago Tribune reports that beginning in June, the FDA will require a new labeling system for prescription medication to help clarify for physicians and expectant parents “the risks and benefits of taking medications during pregnancy and breast-feeding.”

The revisions to prescription guidelines, the first since 1979, will provide more up-to-date and specific information to doctors to enable them to identify the safest treatment options for common conditions during pregnancy. The old labeling system relied on letter grades of A, B, C, D and X. A meant relatively harmless medications and X indicated off-limits. The old letter labels were found to be overly simplistic. With the new system doctors and patients will have quality data to provide more practical guidelines and better answers.

The updated guidelines will give physicians more technical information when prescribing medications, and will consist of three components. The first will give physicians information on dosing and risks to the fetus, and will indicate whether data has been collected to show the drug’s effects. The second will offer what is known about the drug’s impact on breast-feeding. The third section addresses how the product may affect fertility.

Some drug producers have already phased in the changes. Even though consumers will not see the new labels, doctors will have more information to discuss with them.

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