Antimicrobials are among the most commonly used drugs in pregnancy and lactation. They are prescribed for a variety of infections during or following pregnancy, including urinary tract infections, Group B streptococcal colonization, and mastitis. In a recent Centers for Disease Control survey, 30% of women reported taking antibiotics during pregnancy. Antimicrobials can present risks to the pregnant woman (some of which are unique to pregnancy), as well as risks to the unborn fetus or breastfed infant.
In December 2014, the FDA approved new medication labeling requirements for pregnancy and lactation that began to take effect in June 2015. This issue discusses the new labeling, and updates the previous (October 2012) Rx Consultant issue on antimicrobial use in pregnancy and lactation. The principles of adverse drug effects in pregnancy and lactation will be also discussed. Tables 1 and 2 group selected oral antimicrobials into categories based on perceived risks in pregnancy and lactation, with their "retired" FDA pregnancy categories and lactation risk ratings (based on the Hale lactation rating scale), along with commentary. Definitions of the risk categories for both pregnancy and lactation are provided in the appendix of the online version of this issue. Antiretroviral agents for the treatment of HIV infection and hepatitis are not reviewed here because they present a unique set of risk-benefit considerations.
A summary of potential antimicrobial/hormonal contraceptive interactions and counseling advice for patients is provided in the Patient Connection interpretation and prescribing practices. While more detailed information will be available to help guide providers who care for pregnant and breastfeeding patients, the new system also imparts greater responsibility to healthcare providers to protect the mother, unborn fetus, or breastfed baby.
- Pharmacists, Nurse Practitioners, Clinical Nurse Specialists, and Registered Nurses
This CE activity was developed by The Rx Consultant, a publication of Continuing Education Network, Inc.
CE activities for Pharmacists and Pharmacy Technicians:
This continuing education (CE) activity meets the requirements of all state boards of pharmacy for approved continuing education hours. CE credit is automatically reported to CPE Monitor.
CE activities for Nurse Practitioners and Clinical Nurse Specialists:
This continuing education activity meets the requirements of:
The American Nurses Credentialing Center (ANCC) for formally approved continuing education (CE) hours, and CE hours of pharmacotherapeutics.
The American Academy of Nurse Practitioners Certification Program (AANPCP) for acceptable, accredited CE.
This is a pharmacotherapeutics/pharmacology CE activity.
Continuing Education Network, Inc. is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.
Requirements for CE Credit
- Describe 6 types of adverse effects that can occur with prenatal exposure to antimicrobials, and list factors that may increase the risk. Discuss the new labeling requirements for pregnancy and lactation, and the expected impact on clinical practice.
- Identify 4 antimicrobials that pose significant risks in pregnancy and/or lactation such that there would be few or no indications for their use in a pregnant or breastfeeding woman.
- Counsel a mother on strategies to limit her infant’s exposure to an antimicrobial taken during breastfeeding.
- Recommend appropriate management for a patient taking an antimicrobial while using a hormonal contraceptive.
Dominic Chan, PharmD, BCPS
Brief Bio : Dominic Chan, PharmD, BCPS, is Clinical Pharmacist Specialist in Infectious Diseases, University of California, San Francisco Medical Center and Benioff Children’s Hospital.
Disclosure : Dr. Chan report no financial or personal relationship with any commercial interest producing, marketing, reselling, or distributing a product or service that appears in this issue.
Kerri Norman, RPh
Brief Bio : Kerri Norman, RPh is the NICU/Women’s Services Lead Pharmacist at Randall Children’s Hospital, Legacy Emanuel Medical Center in Portland, Oregon.
Disclosure : Ms. Norman reports no financial relationship with the manufacturer(s) or provider(s) of any commercial product(s) or service(s) that appears in this issue.