An overview of upcoming changes in pregnancy and lactation labeling information
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 me...
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| Format: | Article |
| Language: | English |
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Centro de Investigaciones y Publicaciones Farmaceuticas
2015-06-01
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| Series: | Pharmacy Practice |
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| Online Access: | http://www.pharmacypractice.org/journal/index.php/pp/article/view/605/395 |
| _version_ | 1798044116791066624 |
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| author | Mosley JF II Smith LL Dezan MD |
| author_facet | Mosley JF II Smith LL Dezan MD |
| author_sort | Mosley JF II |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-04-11T22:58:41Z |
| format | Article |
| id | doaj.art-92e60a77046b43d885188c1876816261 |
| institution | Directory Open Access Journal |
| issn | 1885-642X 1886-3655 |
| language | English |
| last_indexed | 2024-04-11T22:58:41Z |
| publishDate | 2015-06-01 |
| publisher | Centro de Investigaciones y Publicaciones Farmaceuticas |
| record_format | Article |
| series | Pharmacy Practice |
| spelling | doaj.art-92e60a77046b43d885188c18768162612022-12-22T03:58:16ZengCentro de Investigaciones y Publicaciones FarmaceuticasPharmacy Practice1885-642X1886-36552015-06-01132605605An overview of upcoming changes in pregnancy and lactation labeling informationMosley JF IISmith LLDezan MDBackground: 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.http://www.pharmacypractice.org/journal/index.php/pp/article/view/605/395Drug LabelingPregnancyLactationUnited States Food and Drug AdministrationUnited States |
| spellingShingle | Mosley JF II Smith LL Dezan MD An overview of upcoming changes in pregnancy and lactation labeling information Pharmacy Practice Drug Labeling Pregnancy Lactation United States Food and Drug Administration United States |
| title | An overview of upcoming changes in pregnancy and lactation labeling information |
| title_full | An overview of upcoming changes in pregnancy and lactation labeling information |
| title_fullStr | An overview of upcoming changes in pregnancy and lactation labeling information |
| title_full_unstemmed | An overview of upcoming changes in pregnancy and lactation labeling information |
| title_short | An overview of upcoming changes in pregnancy and lactation labeling information |
| title_sort | overview of upcoming changes in pregnancy and lactation labeling information |
| topic | Drug Labeling Pregnancy Lactation United States Food and Drug Administration United States |
| url | http://www.pharmacypractice.org/journal/index.php/pp/article/view/605/395 |
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