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United States. American law requires that certain drugs and biological products must be labelled very specifically. Title 21, Part 201.57 (9)(i) 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".
In 2014, however, the FDA has developed a "Pregnancy and Lactation Labeling Rule (PLLR)" which requires product labels to include specific information related to the safety and effectiveness of medications to pregnant and lactating women. This ruling has removed the requirement of stating pregnancy categories in prescription drug labels.
Pregnancy category was required on the drug label for systemically absorbed medications with the risk of fetal injury, which is now replaced with pregnancy and lactation labeling rule (PLLR). In addition to pregnancy category requirements on information of pregnancy, labor and delivery, and nursing mothers, PLLR also includes information on ...
For human prescription drug and biological products subject to the Agency's 2006 Physician Labeling Rule, the final rule requires that the labeling include a summary of the risks of using a drug during pregnancy and lactation, a discussion of the data supporting that summary, and relevant information to help health care providers make ...
This category may be empty occasionally or even most of the time. { { Infobox drug }} and { { Chembox }} articles that have a pregnancy category (AU, US) that is not in the pre-formatted list of options. Category should be empty, note that one can always use any-text input in |pregnancy_AU_comment=, |pregnancy_US_comment= .
Methocarbamol. Methocarbamol, sold under the brand name Robaxin among others, is a medication used for short-term musculoskeletal pain. [3] [4] It may be used together with rest, physical therapy, and pain medication. [3] [5] [6] It is less preferred in low back pain. [3] It has limited use for rheumatoid arthritis and cerebral palsy.
Teratology is the study of abnormalities of physiological development in organisms during their life span. It is a sub-discipline in medical genetics which focuses on the classification of congenital abnormalities in dysmorphology caused by teratogens. Teratogens are substances that may cause non-heritable birth defects via a toxic effect on an ...
Pyridoxine/doxylamine, sold under the brand name Diclectin among others, is a combination of pyridoxine hydrochloride (vitamin B 6) and doxylamine succinate.It is generally used for nausea and vomiting of pregnancy (morning sickness); even though its efficacy has not been proven and subsequent research has led to the removal of recommendations in medical journals.