Principles of drug use and management in pregnancy
Medications contraindicated in pregnancy require careful consideration by healthcare professionals. The principles of prescribing in pregnancy involve understanding that 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.
Understanding Pregnancy Risk Classifications
Within the old system, 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 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 and Scope
The labeling changes go into effect on June 30, 2015. The following rules apply to the transition:
- Prescription drugs and biologic products submitted after June 30, 2015, will use the new format immediately.
- 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.
The following table summarizes the data regarding drug classifications and implementation:
| Subject | Details |
|---|---|
| Category C | Insufficient data; potentially harmful, safe, or probably safe. |
| New Labeling Goal | Better patient-specific counseling and informed decision making. |
| Effective Date | June 30, 2015. |
| OTC Medicines | Not affected by the final rule; labeling will not change. |