Medications Contraindicated in Pregnancy and the Evolution of FDA Labeling
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. Category C is the confusing category.
A medication gets this classification if there is insufficient data on its use during pregnancy. It could be safe or probably safe, or it could be potentially harmful.
The New Labeling System
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. Clinical interpretation is still required on a case-by-case basis.
Implementation Timeline and Scope
Prescription drugs and biologic products submitted after June 30, 2015, will use the new format immediately, while labeling for prescription drugs approved on or after June 30, 2001, will be phased in gradually. Labeling for over-the-counter (OTC) medicines will not change; OTC drug products are not affected by the final rule.
Summary of Labeling Requirements
| Product Type | Implementation Status |
|---|---|
| Prescription products submitted after June 30, 2015 | Use the new format immediately |
| Drugs approved on or after June 30, 2001 | Phased in gradually |
| Over-the-counter (OTC) medicines | Not affected by the final rule |