FDA REVISES PRESCRIPTION DRUG LABELS

The Food and Drug Administration has just announced changes to the way prescription drugs will be labeled starting in June 2015.

Mark Denker, M.D.

The current system, which uses categories A, B, C, D, and X, oversimplifies the information required to make an informed decision about what drugs a patient can and cannot take during pregnancy.

For patients undergoing fertility treatment and for the young reproductive age population in general, the FDA has created a new category entirely title “Females And Male Of Reproductive Potential.” They have also combined the categories of labor and delivery and pregnancy together, and created an entirely new category for nursing and lactating mothers.

What does this mean for patients? Now couples who are trying to conceive as well as pregnant and nursing mothers will be able to have more detailed information about the potential risks of a medication and its effects on fertility and breast-feeding. Rather than an oversimplified broad category, which may discourage the use of medications that are actually beneficial. The new risk summary and supporting data will allow patients and doctors to make more informed decisions about medications as it applies to their individual situation and whether or not the benefits outweigh the risks.

The rule takes effect for new drugs approved after June 15th of this year, and will be phased in for existing drugs over the next several years.