December 8, 2022

FDA Drug Categories Old and New

It’s really great to have you welcome back guys in this video we shall discuss about fda pregnancy risk categories we shall discuss prior to 2015 what happened in 2015 and also the new categories also so in 1979 the fda established five letter risk categories a b c d or x to indicate potential of a drug to cause birth defects if used during pregnancy so the

Categories were determined by assessing the reliability of documentation and risk to benefit ratio this categories did not take into account any risks from the pharmacological agents or their metabolites in the breast milk so there are multiple categories a b c d and x have been assigned and they are designated designed to help the reader quickly classify a drug

For use during pregnancy so the category a in this controlled studies in women failed to demonstrate a risk to the fetus in the first trimester so the examples of the drugs or substances include levothyroxine folic acid and lyothera thyron category included animal reproductive studies that have failed to demonstrate a risk to the fetus and there are no adequate

And well-controlled studies in pregnant women so the example of these drugs include metformin hydrochlorothiazide cyclobenzaprine amoxicillin coming to the category c which have these in this animal reproductive reproduction studies have shown an adverse effect on the fetus and there are no adequate and when controlled studies in humans but potential benefits may

Vary use of the drug in the pregnant woman despite potential risks this should be remembered so examples of these drugs include gabapentin amlodipine trizodone etc coming to the category d there is a positive you know there is a positive evidence of the human fetal risk based on adverse reaction data from the investigational and or marketing experience or studies

In human beings so but the potential benefit may vary the use of drugs in pregnant women despite potential risks in this category there is location comes under this category coming to the category x studies and animals or humans have demonstrated fetal abnormalities and or there is a positive evidence of human fetal risk based on adverse reaction they’re from

Various studies example under this include atovastatin simvastatin methotrexate finasteride so in 2015 fda replaced the former pregnancy risk letter categories on prescription and biological drug labeling so which would meaningful to both patients and also healthcare providers so the new labeling system allows better patient specific counseling and also informed

Decision making for pregnant women seeking medication therapies so the pregnancy and lactation labeling final rule went into effect on june 30th 2015. so why did the fda make this change that is a relevant question right so the clinically many women require drug treatment during pregnancy due to chronic conditions such as epilepsy diabetes hypertension or asthma

To withhold drug treatment would be dangerous for both mother and baby in addition women are having babies at a later age which can boost and boost the number of women with chronic condition accessible and understandable pregnancy and lactation information is important for women and their health care providers to assess risk versus benefit so for this reason

So clinicians and patients were often confused by the meaning of the pregnancy risk categories because according to fda it was overly simplistic led to misinformation and did not adequately address the valuable available information so the various categories have been easily and clearly labeled in this so pre-pll labeling that is pregnancy and lactation label

Final rule labeling uh it used to categorize pregnancy labor and delivery and nursing in different categories and this in the newest one in the latest uh edition uh pregnancy are being categorized as one and in which labor is also labor and delivery is also included and nursing mothers have been included on the separate section that is 8.2 lactation and there is

A other specific category 8.3 which includes females and males of reproductive potential so there have been various categories in this so pregnancy includes pregnancy exposure registry risk summary clinical consideration and data these sections are included in the pregnancy section subsection and also lactation also includes risk summary clinical consideration

Data and in females and males of reproductive potential section pregnancy testing contraception infertility are included so there are clear indications in the special population section in the new edition of the fda approved drugs categories so the old category a b c d x have been modified into the new ones so we should follow this and the new categories have

Been followed by the various pharmaceutical companies too thank you very much

Transcribed from video
FDA Drug Categories: Old and New By EMpodliveBroadcastDetails{isLiveNowfalsestartTimestamp2021-05-09T144928+0000endTimestamp2021-05-09T145739+0000}