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Hub AI
Pregnancy category AI simulator
(@Pregnancy category_simulator)
Hub AI
Pregnancy category AI simulator
(@Pregnancy category_simulator)
Pregnancy category
The pregnancy category of a medication is an assessment of the risk of fetal injury due to the pharmaceutical, if it is used as directed by the mother during pregnancy. It does not include any risks conferred by pharmaceutical agents or their metabolites in breast milk.
Every drug has specific information listed in its product literature. The British National Formulary used to provide a table of drugs to be avoided or used with caution in pregnancy, and did so using a limited number of key phrases, but now Appendix 4 (which was the Pregnancy table) has been removed. Appendix 4 is now titled "Intravenous Additives". However, information that was previously available in the former Appendix 4 (pregnancy) and Appendix 5 (breastfeeding) is now available in the individual drug monographs.
American law requires that certain drugs and biological products must be labelled very specifically. Title 21, Part 201.57 (9)(i)[dead link] of the Code of Federal Regulations lists specific requirements regarding the labeling of drugs with respect to their effects on pregnant populations, including a definition of a "pregnancy category". These rules are enforced by the Food and Drug Administration.
To supplement this information, the FDA publishes additional rules regarding pregnancy and lactation labeling.
The FDA does not regulate labeling for all hazardous and non-hazardous substances. Many substances, including alcohol, are widely known to cause serious hazards to pregnant women and their fetuses, including fetal alcohol syndrome. Many other pollutants and hazardous materials are similarly known to cause reproductive harm. However, some of these substances are not subject to drug labeling laws, and are therefore not assigned a "Pregnancy Category" per 21 CFR 201.57.
One characteristic of the FDA definitions of the pregnancy categories is that the FDA requires a relatively large amount of high-quality data on a pharmaceutical for it to be defined as Pregnancy Category A. As a result of this, many drugs that would be labelled as safe in other countries are allocated to Category C by the FDA.
On December 13, 2014, the FDA published the Pregnancy and Lactation Labeling Final Rule (PLLR), which changed the labeling requirements for the pregnancy and lactation sections for prescription drugs and biological agents. The final rule removed the pregnancy letter categories, and created descriptive subsections for pregnancy exposure and risk, lactation, and effects to reproductive potential for females and males. Labeling changes from this rule began on June 30, 2015, with all submissions for prescription drugs and biological agents using the labeling changes immediately. Previously approved drugs from June 30, 2001, will switch to the new labeling gradually. The rule does not affect the labeling of over-the-counter drugs or of drugs approved prior to June 30, 2001.
Australia has a slightly different pregnancy category system from the United States. The categorisation of medicines for use in pregnancy does not follow a hierarchical structure.
Pregnancy category
The pregnancy category of a medication is an assessment of the risk of fetal injury due to the pharmaceutical, if it is used as directed by the mother during pregnancy. It does not include any risks conferred by pharmaceutical agents or their metabolites in breast milk.
Every drug has specific information listed in its product literature. The British National Formulary used to provide a table of drugs to be avoided or used with caution in pregnancy, and did so using a limited number of key phrases, but now Appendix 4 (which was the Pregnancy table) has been removed. Appendix 4 is now titled "Intravenous Additives". However, information that was previously available in the former Appendix 4 (pregnancy) and Appendix 5 (breastfeeding) is now available in the individual drug monographs.
American law requires that certain drugs and biological products must be labelled very specifically. Title 21, Part 201.57 (9)(i)[dead link] of the Code of Federal Regulations lists specific requirements regarding the labeling of drugs with respect to their effects on pregnant populations, including a definition of a "pregnancy category". These rules are enforced by the Food and Drug Administration.
To supplement this information, the FDA publishes additional rules regarding pregnancy and lactation labeling.
The FDA does not regulate labeling for all hazardous and non-hazardous substances. Many substances, including alcohol, are widely known to cause serious hazards to pregnant women and their fetuses, including fetal alcohol syndrome. Many other pollutants and hazardous materials are similarly known to cause reproductive harm. However, some of these substances are not subject to drug labeling laws, and are therefore not assigned a "Pregnancy Category" per 21 CFR 201.57.
One characteristic of the FDA definitions of the pregnancy categories is that the FDA requires a relatively large amount of high-quality data on a pharmaceutical for it to be defined as Pregnancy Category A. As a result of this, many drugs that would be labelled as safe in other countries are allocated to Category C by the FDA.
On December 13, 2014, the FDA published the Pregnancy and Lactation Labeling Final Rule (PLLR), which changed the labeling requirements for the pregnancy and lactation sections for prescription drugs and biological agents. The final rule removed the pregnancy letter categories, and created descriptive subsections for pregnancy exposure and risk, lactation, and effects to reproductive potential for females and males. Labeling changes from this rule began on June 30, 2015, with all submissions for prescription drugs and biological agents using the labeling changes immediately. Previously approved drugs from June 30, 2001, will switch to the new labeling gradually. The rule does not affect the labeling of over-the-counter drugs or of drugs approved prior to June 30, 2001.
Australia has a slightly different pregnancy category system from the United States. The categorisation of medicines for use in pregnancy does not follow a hierarchical structure.