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 ?
When statins were originally marketed in the 1980s, they were labeled pregnancy category X, which means 1) that there is evidence of fetal abnormalities or risk and 2) that these risks clearly outweigh potential benefits.
Phenytoin is a widely used non-sedative antiepileptic drug included in pregnancy category 'D' of teratogenic potential according to the FDA (United States Food and Drug Administration) which justifies the use of this drug if the potential therapeutic benefits outweigh the potential risks1.
Metformin (FDA pregnancy category B) is not recommended as first line treatment of cutaneous manifestations, for prevention of pregnancy complications, or for the treatment of obesity.
It contains about 800 drug profiles (30 new), organized alphabetically, with information on generic and trade names, pharmaceutical company, indications, half-life, interactions, pregnancy category, and categories of adverse reactions/eruptions, with summaries of the number of reports or level of incidence or reaction.
Permethrin is safe for infants 2 months and older, and is a Pregnancy Category B drug.
They are closely related medications [that] interfere with DNA synthesis and both are classified as FDA pregnancy category D," he said.
Although telbivudine has been approved as pregnancy category B by the FDA, there are very few reports about safety of telbivudine treatment in mothers and infants during entire pregnancy.
4) The FDA assigned doxylamine-pyridoxine pregnancy category A because of the extensive evidence that it does not cause an increase in fetal malformations.
Food and Drug Administration (FDA) has determined stimulants fall under pregnancy category C, which indicates animal studies have shown adverse effects on the fetus, but limited evidence from human studies exists on the teratogenic effects of the medication (Drugs.
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.
All typical antipsychotics are pregnancy category C.
3) Of the drugs that did mention "pregnancy," less than half were classified in accordance with FDA pregnancy category ratings.