An overview of upcoming changes in pregnancy and lactation labeling information

Abstract

Background:Many medications can be used safely and effectively to provide health benefits for disease state management during pregnancy with minimal risk to the fetus or mother. Today nine out of ten women take at least one medication during pregnancy, and the number of women taking four or more medications has more than doubled over the past 30 years. However, the lack of safety data combined with the generalizations of the current risk category system (A, B, C, D, X) makes risk versus benefit assessment difficult.Discussion:In response to these concerns, the U.S. Food and Drug Administration (FDA) has decided to implement a new pregnancy and lactation labeling rule designed to improve risk versus benefit assessment of drugs used in pregnant and nursing mothers; this rule is set to take effect in June of 2015. This change is designed to provide clear and detailed information for both patients and healthcare providers pertaining to three main categories: pregnancy, lactation, and females and males of reproductive potential. The new labeling rule also removes the previous letter risk categorization system.Conclusion:The upcoming changes regarding pregnancy and lactation safety labeling are going to have a vast impact on drug safety interpretation and prescribing practices. While this rule will provide practitioners with more detailed information pertaining to pregnancy, lactation, and reproduction, it will also place more responsibility on the practitioners to ensure the safety of their patients. This review will summarize these changes and discuss their potential effect on clinical practice.

An assessment of pregnant women's knowledge and use of the Internet for medication safety information and purchase

“…For this study, a 72-item web-based questionnaire was designed for data collection based on pragmatism as online surveys conserve time and offer an economy of efficiency that is very attractive to both researcher and participant. The construction of the instrument was theoretically underpinned by Rogers (1983) Protection Motivation Theory and items from previously validated instruments were borrowed and adapted with permission from the authors (Lagan et al, 2011;N€ arhi et al, 2008;Peterson-Clark, Aslani, & Williams, 2010).…”

“…Labelling Rule in June 2015 to ensure drug manufacturers provide information on product labels about safety for pregnant and lactating women (Mosley, Smith, & Dezan, 2015 Of the women who participated in the survey 40% (n = 114) had a chronic health condition and 111 (39%) were taking at least one medication when they became pregnant. Swedish researchers report women with chronic conditions such as diabetes and epilepsy appear to be compliant with medication consumption during pregnancy.…”

Clinical management of medications in pregnancy and lactation

“…8 The new label removes the letter-based system and provides information about medications regarding patients in three categories: pregnancy, lactation, and females and males of reproductive potential. The label will provide general information, including contact information for a pregnancy registry where available, followed by a fetal risk summary, which details the likelihood that drugs increase the risk of developmental abnormalities.…”

Knowledge, Attitude and Practice of Community Pharmacists on Medication Safety during Pregnancy: A Cross-sectional Study

“…It was estimated that 90% of pregnant women take at least one prescription or non-prescription drug other than a vitamin or mineral supplements. 3 This raise in medication consumption during pregnancy is majorly due to, change in demographic characteristics, high prevalence of pre-existing co-morbidities and obstetric conditions. 4,5 The most common chronic disorders warrant drug therapy in pregnancy include renal disease, diabetes, depression, thyroid disorders, cardiovascular disorders and asthma.…”