RT Book, Section
A1 Gomella, Tricia Lacy
A1 Eyal, Fabien G.
A1 Bany-Mohammed, Fayez
SR Print(0)
ID 1168359646
T1 Effects of Drugs and Substances on Lactation and Infants
T2 Gomella's Neonatology: Management, Procedures, On-Call Problems, Diseases, and Drugs, 8e
YR 2020
FD 2020
PB McGraw-Hill Education
PP New York, NY
SN 9781259644818
LK accesspediatrics.mhmedical.com/content.aspx?aid=1168359646
RD 2024/04/19
AB The  chapter  provides  some  summary  data  on  some  of  the  medications  and  substances  that  may  be  taken  by  the  mother  during  pregnancy  and/or  breast  feeding.  Regardless  of  the  designated  risk  category  or  presumed  safety,  no  drug  or  substance  should  be  used  during  pregnancy  and/or  breast  feeding  unless  it  is  clearly  needed  and  the  potential  benefits  clearly  outweigh  the  risks.  The  table  lists  the  generic  medication  name  and,  in  parentheses,  the  US  Food  and  Drug  Administration  (FDA)  fetal  risk  category  followed  by  the  breast-feeding  compatibility.  At  the  present  time,  there  is  no  formally  FDA-sanctioned  breast-feeding  category,  and  the  system  used  here  is  discussed  later.  Lastly,  any  reported  effects  on  lactation  or  on  infant  effects  based  on  breast  milk  consumption  are  noted.  The  editorial  board  has  made  an  attempt  to  summarize  the  data  based  on  the  best  information  available  for  an  individual  agent  where  sources  disagree.  These  data  are  subject  to  change  as  new  information  becomes  available.  The  reader  is  advised  to  consult  the  FDA  (www.fda.gov)  and  manufacturer’s  website  for  the  latest  information  concerning  risks  of  these  medications.  The  FDA  developed  a  revised  labeling  that  replaces  the  old  5-letter  (A,  B,  C,  D,  X)  system  with  more  helpful  information  about  a  medication’s  risks  to  the  expectant  mother,  the  developing  fetus,  and  the  breast-fed  infant.  The  labeling  changes  went  into  effect  on  June  30,  2015,  for  all  new  drugs,  which  will  use  the  new  format  immediately,  whereas  labeling  for  prescription  drugs  approved  on  or  after  June  30,  2001,  will  be  phased  in  gradually.  Lactation  will  include  (1)  risk  summary;  (2)  clinical  considerations;  and  (3)  data.  This  project  will  take  several  years  to  complete.  Labeling  for  over-the-counter  (OTC)  medicines  will  not  change.