FDA Proposes Changes to Pregnancy, Lactation Sections of Prescription Drug Labels
Agency Invites Physician Comments
By News Staff
6/11/2008
The FDA has proposed a major overhaul of its system for labeling prescription drugs and biological products to give physicians and their patients a clearer picture of the risks and benefits of using these drugs during pregnancy and lactation.
The proposed rule would eliminate use of the current pregnancy categories A, B, C, D and X, which stakeholders have criticized as oversimplified and not conducive to updates when new information becomes available.
According to an FDA news release, the proposed new format for the pregnancy section of prescription drug labeling would include three subsections.
According to an FDA news release, the proposed new format for the pregnancy section of prescription drug labeling would include three subsections.
- Fetal Risk Summary. This subsection would outline the known effects of the drug on the fetus and, if specific risks were identified, indicate whether that determination was based on information gleaned from animal or human studies. Specifically, the FDA proposal calls for development and presentation of a "risk conclusion" based on the available data.
- Clinical Considerations. This subsection would present information about the effects of using the drug before a woman knows she is pregnant. It also would discuss the risks of disease to the mother and infant, provide dosing information for the drug, and describe possible complications and strategies to manage them.
- Data. This final subsection of the label would describe, in greater detail, the data available on the drug, including findings from both human and animal studies.
The pregnancy section of each drug label also would indicate whether a pregnancy exposure registry exists for the drug.
The proposal calls for a similarly formatted lactation section to provide information about use of the drug in nursing mothers. This section would contain information about drug excretion in breast milk and the potential effects in breastfed infants.
Visit the FDA's Center for Drug Evaluation and Research Web site for more information about the proposal, including specific examples of the new label format.
The FDA invites comments on the proposed rule for 90 days from its May 28 publication date. Electronic comments may be submitted via the Federal Documents Management System/eRulemaking portal.
The proposal calls for a similarly formatted lactation section to provide information about use of the drug in nursing mothers. This section would contain information about drug excretion in breast milk and the potential effects in breastfed infants.
Visit the FDA's Center for Drug Evaluation and Research Web site for more information about the proposal, including specific examples of the new label format.
The FDA invites comments on the proposed rule for 90 days from its May 28 publication date. Electronic comments may be submitted via the Federal Documents Management System/eRulemaking portal.
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