What is the warning recommendations of “FDA pregnancy “-- categorization in pregancy

The FDA assigned   pregnancy  categories    as used in the Drug  Formulator are as  follows :

Category  A :Adequate and well controlled studies have failed  to demonstrate a risk to the fetus  in the first  trimester of pregnancy  

Category B :-Animal    reproduction studies  have failed to demonstrate a risk to the fetus  and there are no   adequate    and well controlled   studies  in pregnant  women.

Category C :- Animal   reproduction studies  have  shown an adverse  effect  on the fetus  and there   are no adequate   and well    controlled  studies  in humans, but   potential  benefits  may  warrant  use of  the   drug in pregnant   women despite   potential  risks.

Category D :-There  is positive    evidence  of human  fetal   risk  based  on adverse   reaction   data from investigational   or marketing  experience   or studies  in humans, but  potential  benefits  may warrant use of the drug in pregnant  women despite    potential risks. 

Category X :_Studies  in animals   or humans    have demonstrated fetal   abnormalities   and / or  there is  positive   evidence of human fetal  risk based on adverse  reaction   data from investigational   or marketing   experience   and the risks  involved  in the use of  the drug in pregnant   women clearly     out weight   potential   benefits.

Salient points on few commonly / uncommonly used drugs in pregancy: Drug 7 :-Urosodeoxycholic Acid – FDA pregnancy   category B.Uses  and safety – Low risk    use in ICP -Drug 1:-Trientine FDA   pregnancy category C , Uses  and safety – Limited   data potential toxicity . Drug 2=Azathiprine  - FDA pregnancy   category  D – Uses and  safety – Data   suggest low risk . Drug 3= Penicillamine – FDA pregnancy  Drug 4:- Therapy      for Wilson’s  disease  category D- Uses  and safety – Embryopathy    but need to maintain  therapy      for Wilson’s  disease  Drug 5:-Vasopressin – FDA  pregnancy  category X, uses  and  safety – Contraindicated    , Causes   uterine   ischemia Drug 6:- Ribavarin – FDA  pregnancy    category X, Uses   and safety – Contraindicated   as it causes   severe    fetal toxicity   .

Drug 8 : Oetreotide – FDA pregnancy category B, Uses  and safety – Probably   safe limited  data :Drug 9

Prednisolone – FDA pregnancy  category C,  uses  and safety  - Low risk  ,Risk of cleft  palate  and adrenal   insufficiency Drug  10:-Cyclosporine – FDA  pregnancy   category  C, Uses   and safety – Most   safety  data of immunosuppressant Drug 11:-Tacrolimus – FDA  pregnancy  category C – Uses   and safety Probably  safe. Use    as needed , Drug 12;- Mycophenylate –FDA pregnancy  category C . Uses and safety – Not   recommended   . Drug 13:- Limited data on

Sirolimus – FDA  pregnancy  category C – Uses  and   safety – Not   recommended ::Drug 14:: Lamivudine – FDA  pregnancy  category C .  Uses and safety – Low risk .

Drug 15:- Adefovir – FDA  pregnancy    category C . Uses and safety --  Few   data  . Limited toxicity 

Drug 16::Entecavir – FDA pregnancy category  C . Uses  and safety – Few data . Not   recommended

Drug 17 :: Interferone – FDA pregnancy  category C . Uses and safety – Not   recommended.