Pregnancy category


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Pregnancy category

A system of classifying drugs according to their established risks for use during pregnancy. Category A: Controlled human studies have demonstrated no fetal risk. Category B: Animal studies indicate no fetal risk, but no human studies; or adverse effects in animals, but not in well—controlled human studies. Category C: No adequate human or animal studies; or adverse fetal effects in animal studies, but no available human data. Category D: Evidence of fetal risk, but benefits out-weigh risks. Category X: Evidence of fetal risk. Risks outweigh any benefits.
References in periodicals archive ?
For seizures and migraines, the FDA has labeled topiramate a pregnancy category D drug (there is evidence of human fetal risk, but "the potential benefits from the use of the drug in pregnant women may be acceptable despite its potential risks.
Adderall) in Pregnancy Category C, meaning "animal reproduction studies [using doses much higher than people generally take] have shown an adverse effect on the fetus," but "there are no adequate and well-controlled studies in humans.
The pregnancy category for valproate for the migraine indication will be changed from a "D" -- designated for drugs where the potential benefit for a pregnant woman might be acceptable despite its potential risks--to a category "X," designating that the risk of the drug in a pregnant woman "clearly outweighs any possible benefit of the drug," according to the FDA advisory, issued May 6.
For this reason, Aubagio is labeled as Pregnancy Category X, which means women of childbearing age must have a negative pregnancy test before starting the drug and use effective birth control during treatment.
About 30 per cent of women who come to us belong to the late pregnancy category.
This edition has 65 new profiles, pregnancy category information for about 1,100 drugs, updates to existing profiles, highlighted review articles, and specific reactions that could occur from drug combinations.
The monographs list therapeutic class, disorders, dosage, formulations, side effects, warnings, and pregnancy category.
Most SSRIs and bupropion are rated Pregnancy Category C by the Food and Drug Administration.
7,8) Benzodiazepines are pregnancy category X and thus are contraindicated in these patients.
Thus, our results raise questions about the validity of combining all mistimed pregnancies, regardless of degree of mistiming, into a single mistimed pregnancy category or of combining them with unwanted pregnancies into an unintended pregnancy category.
Section 8 of the product labeling, "Use in Specific Populations," was updated to include additional animal data and a Clinical Consideration section, with the pregnancy category remaining unchanged.