New Prescription Drug Labeling
May 7, 2015
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The new FDA rule will require more information about a drug’s effect on pregnant and nursing women.

A rule affecting prescription drug and biological product labels will go into effect on June 30, 2015.  This rule will change the way that labels address risks of use during pregnancy and breastfeeding.  The new rule was published in the Federal Register by the Food & Drug Administration (FDA) on December 3, 2014.  Beginning in June, all new labels will have to use the new requirements immediately, while previously approved products will be phased in overtime.

Current Labeling

The current format for prescription drugs includes a letter category system.  Categories A, B, C, D, X and N indicate the potential risk level if used during pregnancy.  The categories are determined based on the reliability of available information and a risk-benefit ratio.   Category N means that the drug has not been classified by the FDA, such as aspirin or diazepam. Category A has the lowest risk, where controlled studies have not shown a risk to the fetus.  Examples of current Category A drugs are folic acid and amoxicillin.  Categories B, C, and D have increasing risk, ranging from some risk shown in animal studies to positive evidence of risk in humans.  Category X is the most serious risk, and pregnant women should not take drugs in this category.   An example of a current Category X drug is warfarin, a common blood thinner.

The New Rule


The new final rule will change the format of the labels and adds more information.  The information required by the new rule will most likely be in the labeling information provided to doctors, which is generally provided to consumers in pharmacy inserts. The new labeling will include information in three subsections:

  • Pregnancy,
  • Lactation, and
  • Females and Males of Reproductive Potential

The information that will appear under these headings will include:

  • effects the drug may have on risks during pregnancy
  • whether the medication can transfer or secrete into breast milk
  • and effects on pregnancy testing, contraception and fertility.

The label will also include information on any existing registries that study effects of that drug on pregnancy.  The FDA states in the final rule that it is part of a broad effort to improve content and format of labeling in prescription drugs.  The FDA is hopeful that the new labeling will help physicians in making treatment decisions with their patients by providing relevant, user-friendly information.  This type of new information may be particularly helpful for those with chronic medical conditions who need to take a prescription drug during pregnancy and lactation.

Implementation of the New Labels

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Drugs and biological products which have applications submitted to the FDA after the effective date of the rule will have to implement the new labeling immediately.  All drugs and biological products previously approved will be required to phase in the new labeling over a period of three to five years.  The new rule only applies to prescription drugs and biological products. It will not have an impact on over-the-counter medications, herbal remedies or supplements.

For more information about this important change to prescription drug labeling, please visit the FDA Questions and Answers page here.