Volume. 35, No. 2 july. 2011 - The Chest and Heart Association of ...

Chest & Heart Journal Vol. 35, No.-2, July 2011FDA Pregnancy Risk CategoryCategoryABCDXInterpretationControlled studies show no risk, Adequate, well-controlled studies in pregnant womenhave failed to demonstrate a risk to the fetus in any trimester of pregnancyNo evidence of risk in humans. Adequate well-controlled studies in pregnant womenhave not shown increased risk of fetal abnormalities despite adverse findings in animals,orin the absence of adequate human studies ,animal studies show no fetal risk .The chanceof fetal harm is remote,but remains a possibilities .Risk cannot be ruled out.Adequate well-controlled human studies are lacking and animalstudies have shown a risk to the fetus or are lacking as well there is a chance of fetalharm if the drug is administered during pregnancy but the potential benefits mayoutweigh the potential riskPositive evidence of risk .Studies in humans, or investigational or post marketing data,have demonstrated fetal risk.Nevertheless, potential benefits from the use of the drugmay outweigh the potential risk.Contraindicated in pregnancy . Studies in animals or humans or investigational or postmarketing reports have demonstrated positive evidence of fetal abnormalities or riskthat clearly outweighs any possible benefits to the patients .FDA Pregnancy risk category, TERIS rating of asthma medication 5Medication Risk Category TERIS rating(magnitude of teratogenic Risk/Quality,Quantity of Data)Salbutamol C Undetermined/LimitedLevo-salbutamol C NASameterol C Undetermined/Very LimitedBeclomethasone C Unlikely/Limited to FairBudesonide B Unlikely/Limited to FairFluticasone C NAMometasone C Undetermined/LimitedTriamcinolone C Undetermined/LimitedFluticasone/salmeterol C NAOral steroidCCromolyn B Unlikely/Fair to GoodNedocromil B Undetermined/Very LimitedMontelukast D Undetermined/LimitTheophylline C None/Fair to GoodSteps of Asthma Therapy during PregnancyStep Preferred Controller Medication Alternative Controller Medication1 None2 LDICS LTRA,theophylline,or cromolyn3 MDICS LDICS plus LABA,LTRAor theophylline4 MDICS plus LABA MDICS plus either LTRA or theophylline5 HDICS plus LABA6 HDICS plus LABA plus oral prednisolone110