Table 8: U.S. Food and Drug Administration Information that will be in the Pregnancy and Lactation Labeling Rule (PLLR) Section for Pregnancy and Lactation General Information Risks Clinical Considerations Background Data Lactation General information is not mandated in rule. • Risk Summary: Information from all relevant sources is included and identified. • Statement that drug is compatible with • Label will provide the following information, when available:
• Overview of the data that are the basis of Risk Summary and Clinical Considerations. • Human data to be presented first.
▪ Strategies to minimize exposure to the child, including topical drugs
breastfeeding if no effect on quality of milk, quantity of milk; if nondetectable in milk; or no adverse effects found with child. • As applicable, a summary of the drug and effect on milk production, presence in milk, and effects on child will be included.
to nipple; information about potential drug effects that could be useful to caregivers, such as monitoring for adverse effects, how to respond when they occur; and information about adjustments of maternal doses.
Females and Males of Reproductive Potential
• Risks are not specially noted as part of Females and Males of Reproductive Potential, but the following address when it must be included and imply risks: ▪ When pregnancy testing and/ or contraception are required or recommended before, during, or after drug therapy and/or ▪ When there are human and/or animal data that suggest drug-associated fertility effects. • Clinical considerations are not specifically noted as part of Females and Males of Reproductive. • Potential, but the following list content of potential clinical importance must be included, in order: ▪ Pregnancy testing. ▪ Contraception. ▪ Infertility. Note . U.S. Food and Drug Administration (2016). Pregnancy and lactation labeling final rule [online]. Retrieved from: https://www.gpo.gov/fdsys/
pkg/CFR-2016-title21-vol4/xml/CFR-2016-title21-vol4-sec201-57.xml. In 2015 the FDA replaced the former pregnancy risk letter categories on prescription and biological drug labeling with new information to make them more meaningful to both patients and healthcare providers (Brucker & King, 2017). The old five-letter system left patients and providers ill- informed and resulted in false assumptions about the actual meaning of the letters. 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. Also, the Pregnancy and Lactation Labeling Final Rule (PLLR) went into effect on June 30, 2015 yet the timeline for implementing this new information on drug labels (also known as the package insert ) is still variable. Clinical interpretation is still required on a case-by-case basis, and for this reason, most practitioners continue to rely on the traditional five-letter system. The A, B, C, D and X risk categories, in use since 1979, are now replaced with narrative sections and subsections as shown in Table 9 (U.S. Food and Drug Administration, 2016).
Table 9: Key Medication Considerations During Pregnancy and Breastfeeding Medication FDA Risk Category**
Safe During Pregnancy?
Safe During Breastfeeding?
Acetaminophen
B
Yes
Yes
Aspirin*
C/D
Avoid
Avoid
Codeine
C
Use with caution
Yes
Glucocorticoids (dexamethasone, prednisone)
C
Avoid***
Yes
Hydrocodone
C
Use with caution
Use with caution
Ibuprofen*
C/D
Avoid in 3rd trimester
Yes
Oxycodone
B
Use with caution
Use with caution
EliteLearning.com/ Dental
Book Code: DHFL2624
Page 175
Powered by FlippingBook