Former FDA risk Categories and examples of drugs
The FDA established a five letter categorization in the year 1979. The purpose of the category was to suggest possible drugs that could cause defects in birth when used during the pregnancy ( Drugs. Com, 2016) . The categories hardly took into consideration the risks that would emanate from pharmaceuticals.
Category A
The category suggested that adequate and well-regulated research have failed to show the risk posed to the foetus in the first pregnancy trimester and a lack of evidence in the subsequent trimesters ( Drugs. Com, 2016) . Examples of drugs in the category include the liothyronine and levothyroxine as well as folic acid.
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Category B
Reproduction studies in animals have failed to show risk posed to the foetus and there is insufficient well-controlled studies in regards to pregnant women ( Drugs. Com, 2016) . Examples of drugs in the category include metformin, cyclobenzaprine, pantoprazole, hydrochlorothiazide and amoxicillin.
Category C
The studies in animal reproduction insist that there is an adverse effect on the foetus with no adequacy of well-controlled studies in the humans although probable benefits warrant the use of drugs in the pregnant women despite the significant risks. Examples of drugs in the category include tramadol, amlodipine, trazodone and gabapentin ( Drugs. Com, 2016) .
Category D
Positive evidence exists of human foetal risks on the adverse reactions from the reaction data and investigational or experience in marketing experience and studies to the human beings ( Drugs Com, 2016) . However, potential benefits stand to warrant usage of the drugs in pregnant women despite the serious risks.
Category X
Studies conducted in animals and humans have proved that foetal abnormalities exists with evidence of human foetal risks that depend on the reaction data from investigational and marketing experience in light of the risks entailed in usage of drugs by pregnant women ( Drugs. Com, 2016) . Example of the drugs in the category includes atorvastatin, warfarin, finasteride, simvastatin and methotrexate.
The New Pregnancy and Lactation Labelling Rule
The PLLR was affected on 30 th of June in the year 2015 and insisted that all prescription drugs remove the pregnancy letter categories in a gradual process that will terminate in the year 2020 (FDA, 2016). The rule does well to reorganize information issued in the prescription labelling of drugs to ensure they are clearer in describing data that aids decisions and patient counselling using the prescription drugs.
Labelling of approved drugs since the effective date of PLLR
As earlier mentioned, Pregnancy and Lactation Labelling Final Rule (PLLR) became effective on June 30 in the year 2015 (FDA, 2016). The prescription drugs approved by the FDA after the rule took course although the process is ongoing. One example of the new category is the pregnancy that entails labour and delivery with the aspects of pregnancy exposure registry, clinical considerations, data and risk summary.
The subsection of Pregnancy provides information on dosing and the potential risks involved in the developing foetus as well as the registry of information that both collects and maintains the data on how the pregnant women get influenced when using drugs or biological products. Information in the labelling of the drug is in regards to the existence of pregnancy registries that have been previously recommended but not required till date (FDA, 2016). The information of contact registry also included and the pregnant women encouraged to enrol and help in provision of data on the effects of usage of drugs and pregnancy biologics. The subheadings of the risk summary are always needed and remain important.
4 .
I think and firmly believe that the new rule is better than the previous category because it provides detailed prescription that helps people make informed and quick decisions that will help pregnant women. It is important that the new rules take into account the need to provide proper information to the people and help avoid making mistakes by patients.
References
Drugs. Com. (2016). FDA Pregnancy Categories: FDA , 1.
FDA. (2016). Pregnancy and Lactation Labeling Rule (PLLR) UCM520454, 1-40.
