Evidence-Based. Clearly Delivered.
Evidence-Based. Clearly Delivered.
In December 2014, the FDA published the Content and Format of Labeling for Human Prescription Drug and Biological Products: Requirements for Pregnancy and Lactation Labeling, referred to as the “Pregnancy and Lactation Labeling Rule” (PLLR or final rule). This rule has changed the content and format for information presented in prescription drug labeling to help health care providers in assessing benefit versus risk and the ensuing counseling of pregnant women and nursing mothers who need to take medication. Most women take at least one medication during pregnancy and many pregnant women have chronic conditions—such as asthma, high blood pressure, and depression – that require them to continue taking medications that they were taking when not pregnant. Because pregnancy may exacerbate these conditions, stopping the medications due to fear of risk to the pregnancy may actually cause more harm than good. Furthermore, a new section entitled Females and Males of Reproductive Potential was added to provide a consistent format and location for inclusion of relevant information for health care providers about pregnancy testing, contraception, and infertility.
The PLLR states the following
If data demonstrate that a drug is not absorbed systemically, the “Risk Summary” must contain only a specified statement regarding this fact. If data demonstrate that the drug is absorbed systemically, the “Risk Summary” must include risk statements based on data from all relevant sources (human, animal, and/or pharmacologic), that describe, for the drug, the risk of adverse developmental outcomes.
The labeling must also contain relevant information, if it is available, to help health care providers make prescribing decisions and counsel women about the use of the drug during pregnancy; this could include information on disease-associated maternal and/or embryo/fetal risk, dose adjustments during pregnancy and the postpartum period, maternal adverse reactions, fetal/neonatal adverse reactions, and/or the effect of the drug on labor or delivery.
The final rule went into effect June 30, 2015. Therefore any drugs submitted to FDA after that date will be labeled using the new system. Drugs approved prior to that date were phased out and were required to be using the new labeling system by June 2018. Most important, the PLLR also requires the label to be updated when information becomes outdated.
Adequate and well-controlled studies have failed to demonstrate a risk to the fetus in the first trimester of pregnancy (and there is no evidence of risk in later trimesters)
Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women
Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks
There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks
Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits
NOTE: Find more information on specific drugs and their safety during pregnancy and lactation at MotherToBaby, a service of the non-profit Organization of Teratology Information Specialists (OTIS)
Narrative Sections and Subsections
Pregnancy and Lactation Labeling (Drugs) Final Rule
The US FDA pregnancy lactation and labeling rule – Implications for maternal immunization
Old FDA Pregnancy Categories (A,B,C,D,X)
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