FDA Proposes Changes to Pregnancy Information on Labels
The system that uses letters of the alphabet to categorize drugs' pregnancy and lactation risks will be eliminated and replaced by a more consistent format designed to be more comprehensive and useful to health care professionals and patients who are of childbearing age, pregnant, or breast-feeding, the Food and Drug Administration recently announced.
The proposed rule would change the content and format of the pregnancy and lactation information that is included in the labeling of human drugs and biologics. Under the proposal, the drug label “would explain the potential benefits and risks for the mother, and the developing baby or fetus, and how these risks may change over the course of pregnancy,” Dr. Sandra Kweder, deputy director of the FDA's Office of New Drugs, said during a media briefing.
Established in 1979, the current category system uses the letters A, B, C, D, and X to indicate degrees of risk associated with a drug or biologic during pregnancy. The system has been criticized by many in the medical community as providing an inaccurate and oversimplified view of the information available on a drug, and has caused difficulty in updating specific labels as new information on drugs becomes available.
Under the proposed rule, labels would also include “relevant clinical information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy and/or lactation,” according to the FDA.
The letter system would be replaced by a pregnancy section, which would contain three subsections:
▸ The “Fetal Risk Summary” would summarize known risks of the drug for a fetus and, in the event of a risk, would explain whether that risk is based on human and/or animal data.
▸ “Clinical Considerations” would include information about the effects of a drug taken by a woman before she knows she is pregnant.
▸ “Data” would provide details on the available human and animal data found in the fetal risk summary on the effects of the drug.
The pregnancy section would also contain information about available pregnancy registries of women exposed to specific drugs.
There would also be a lactation section, which would include the same three subsections used in the pregnancy section.
The section on labor and delivery, which is included in current labels, would be eliminated; information on a drug used during labor and delivery would be included in the pregnancy section.
Once the rule is finalized, the new format would be required for the labels of newly approved drugs. Manufacturers of drugs that are already approved would be required to comply over a certain number of years or when another change is made to the label.
