NURS 651AdvJanuary 28, 2018 FDA Risk FactorsExplain the FDA risk categories as they stand today and give an example of a drug in each one. There are 5  FDA risk categories A,B,C,D and X. Category A:  Example of a category “A” drug is folic acid. This is an example of the safest drug. There is no evidence of a risk in later trimesters. Controlled studies in women fail to demonstrate a risk to the fetus in the first trimester, and the possibility of fetal harm appears remote. Category B:  An example of this drug is Tylenol. Either animal-reproduction studies have not demonstrated a fetal risk but there are no controlled studies in pregnant women or animal-reproduction studies have shown an adverse effect besides a decrease in fertility, that was not confirmed in controlled studies in women in the first trimester. Category C: An example of a category “C” is Cipro and Levaquin. These antibiotics could cause problems with the baby’s muscle and skeletal growth.  This is a risk is not ruled out type of drug. Studies in animals have revealed adverse effects on the fetus both teratogenic or embryocidal and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the fetus. Category D:  An example of a category “D” drug is Phentoin, which is an anticonvulsant. There is positive evidence of human fetal risk, but the benefits from use in pregnant women may be acceptable despite the risk.Category X: An example of a category “X” is warfarin. It is proven to demonstrated fetal abnormalities, or there is evidence of fetal risk based on human experience or both, and the risk of the use of the drug in pregnant women clearly outweighs any possible benefit. The drug is contraindicated in women who are or may become pregnant. There is a new section that will focus on Females and Males of Reproductive Potential. This section will include information describing when pregnancy testing or contraception is required or recommended before, during or after use of the drug product, and relevant animal or human data suggest drug-associated fertility effects. Subheadings will include Pregnancy Testing, Contraception and Infertility. Under the new Pregnancy and lactation labeling rule (PLLR), it has not changed substantially. But the way the information is organized and described, and the amount of information on the label, will improve and change. The information described in Risk Summary will include an assessment, characterization, and summary of known risks to the developing fetus.The pregnancy section will include information organized into three subheadings: Risk Summary, Clinical Considerations, and Data. This information will include potential risks to the developing fetus which includes an assessment of risk, know dosing alternatives when pregnant. And effects on timing and duration of exposure during pregnancy. The Lactation section has three subheadings: Risk Summary, Clinical Considerations, and Data.  If the information is  available, information may include drug concentrations in milk and relative to plasma concentration, and effects of the drug upon milk production and whether the drug as compatible with breastfeeding*Select GI drugs for extra credit. You will receive 1 point for each category in which a GI drug is selected, up to a total of 5 points. References References FDA,(2016). Food and Drug Administration. Federal Register 2016 ; 44:37434–67Buttaro, T., Trybulski, J., Bailey, P., & Sandberg-Cook, J. (2016). Primary care: A collaborative practice (5th ed.). St. Louis: Elsevier MosbyGrossman, S. C., & Porth, C. M. (2014). Porth’s Pathophysiology: Concepts of Altered Health States. (Ed. 9th). Lippincott, Williams & Wilkins. Philadelphia, PA