The New Pregnancy and Lactation Labeling Rule.
نویسندگان
چکیده
To address the need for updated pregnancy risk categories, the Food and Drug Administration published a final rule in 2014. The authors review the changes the rule makes, its implementation schedule, and its potential clinical impact.
منابع مشابه
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 medications has more than doubled over the past 30 years. However, the lack of safety data combined ...
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Dermatologists should be aware that the new Pregnancy and Lactation Labeling Rule (PLLR) has taken effect on June 30th, 2015. This mandate from the Federal Drug Administration (FDA) eliminated the standard pregnancy category letters for prescription medications (A, B, C, D and X). The new recommendations are now in the form of drug labeling that contains increased detail but also increased comp...
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The rapid development and increased availability of novel pharmacologic therapies and pharmaceutical products has amplified the potential for drug exposure during pregnancy. Many drugs are beneficial for disease state management during pregnancy and provide significant fetal and maternal health benefits. However, a paucity of safety data combined with the imprecision of the current risk categor...
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With more than 6 million pregnancies in the United States every year, and with pregnant women taking an average of three to five prescription drugs during pregnancy, physicians and their patients depend on proper safeguards to make informed decisions about medication choices. The U.S. Food and Drug Administration (FDA) has recently implemented the Pregnancy Lactation Labeling Rule (PLLR), which...
متن کاملDrug safety: Pregnancy rating classifications and controversies.
This contribution consolidates data on international pregnancy rating classifications, including the former US Food and Drug Administration (FDA), Swedish, and Australian classification systems, as well as the evidence-based medicine system, and discusses discrepancies among them. It reviews the new Pregnancy and Lactation Labeling Rule (PLLR) that replaced the former FDA labeling system with n...
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عنوان ژورنال:
- P & T : a peer-reviewed journal for formulary management
دوره 41 11 شماره
صفحات -
تاریخ انتشار 2016