Understanding the Risk Labeling of Medications in Pregnancy
Clinicians and patients were often confused by the meaning of the pregnancy risk categories because, according to the FDA, it was overly simplistic, led to misinformation, and did not adequately address the available information.
The Challenges of Category C Medications
Category C is the confusing category. A medication gets this classification if there is insufficient data on its use during pregnancy. In these cases, it could be safe or probably safe, or it could be potentially harmful.
Transition to the New Labeling System
To improve transparency, the labeling changes go into effect on June 30, 2015. The new labeling system allows better patient-specific counseling and informed decision making for pregnant women seeking medication therapies. While the new labeling improves the old format, it still does not provide a definitive “yes” or “no” answer in most cases. Therefore, clinical interpretation is still required on a case-by-case basis.
Implementation and Scope
The timeline for these changes depends on the product type and approval date:
- Immediate implementation: Prescription drugs and biologic products submitted after June 30, 2015, will use the new format immediately.
- Phased implementation: Labeling for prescription drugs approved on or after June 30, 2001, will be phased in gradually.
- No Change: Labeling for over-the-counter (OTC) medicines will not change; OTC drug products are not affected by the final rule.