April  10,  2013    Non-­‐Profit  Answers  Questions  About  New  Drug  Aimed  At  Treating  Nausea  And  Vomiting  In  Pregnancy;  Experts  Say  The  Drug  May  Help  Curb  Some  Pregnancy  Complications    Brentwood,  TN  –  As  the  U.S.  Food  and  Drug  Administration  (FDA)  announces  approval  of  Diclegis  (docylamine  succinate  and  pyridoxine  hydrochloride)  to  treat  nausea  and  vomiting  in  pregnancy  (NVP),  MotherToBaby  experts  have  begun  fielding  questions  about  the  much-­‐debated  drug’s  risks  to  a  woman’s  developing  baby.      Experts  at  MotherToBaby,  the  counseling  service  branch  of  the  non-­‐profit  Organization  of  Teratology  Information  Specialists  (OTIS),  said  NVP  affects  nearly  80%  of  pregnant  women,  usually  in  their  first  trimester.  A  smaller  proportion  of  women  develop  hyperemesis  gravidarum,  a  much  more  severe  form  of  NVP.  A  pregnant  woman  who  develops  hyperemesis  gravidarum,  may  potentially  deliver  a  smaller  baby.  “Babies  who  are  born  at  a  lower  birth  weight  can  be  predisposed  to  other  complications,”  explained  Robert  Felix,  a  senior  teratogen  information  specialist  for  MotherToBaby’s  California  affiliate  at  the  University  of  California,  San  Diego.  “Diclegis  might  help  to  possibly  curb  that  result.”    However,  the  FDA’s  decision  to  approve  the  drug  did  not  happen  overnight.  The  particular  treatment  has  an  extensive  history  associated  with  it.  A  similar  drug,  Bendectin,  that  was  made  available  in  the  U.S.  in  1956  for  the  treatment  of  NVP,  became  widely  used  by  pregnant  women,  but  was  not  well  studied  until  nearly  two  decades  later.    Those  studies  failed  to  associate  Bendectin  with  an  increased  risk  for  a  pattern  of  major  birth  defects.  Even  with  those  results,  the  manufacturer  voluntarily  withdrew  the  drug  from  the  U.S.  market  in  1983  over  litigation  based  on  unfounded  concerns  for  birth  defect  risks.    Sales,  however,  continued  in  the  United  Kingdom  as  Debendox  and,  more  recently,  as  Diclectin  in  Canada.  “We  think  we’ll  get  a  lot  of  concerned  calls  about  Diclegis,”  said  Felix.  “We’d  like  to  educate  pregnant  women  and  their  providers  about  the  efficacy  of  this  drug  for  NVP  because,  generally,  pregnant  women  do  not  seek  treatment  because  their  concern  about  safety,”  he  added.    Felix  referred  to  observational  (epidemiological)  studies  that  have  shown  the  combination  of  active  ingredients  in  Diclegis  does  not  pose  an  increased  risk  of  harm  to  the  fetus.  Also,  a  clinical  trial  of  261  women  taking  Diclegis  to  treat  NVP  showed  the  rate  of  birth  defects  did  not  differ  between  the  women  who  took  the  drug  versus  those  who  took  a  placebo.  In  addition,  the  NVP  symptoms  among  women  taking  the  drug  improved.      Those  with  questions  about  Diclegis  or  other  medications  during  pregnancy  and  breastfeeding  are  encouraged  to  call  MotherToBaby  experts  toll-­‐FREE  at  866-­‐626-­‐6847  or  by  visiting  MotherToBaby.org.  MotherToBaby  and  OTIS,  which  are  suggested  resources  by  many  agencies  including  the  Centers  for  Disease  Control  and  Prevention  (CDC),  are  dedicated  to  providing  

evidence-­‐based  information  to  mothers,  health  care  professionals,  and  the  general  public  about  medications  and  other  exposures  during  pregnancy  and  while  breastfeeding.      

#  #  #  

 Media  Contact:  Nicole  Chavez,  858-­‐246-­‐1745,  nchavez@mothertobaby.org.  Interviews  in  Spanish  can  also  be  arranged.