Drugs in Pregnancy Breastfeeding

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Drugs in Pregnancy/ Breastfeeding

• Carla Scuderi

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Too much to cover here today...

• However a key questions have been asked

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SSRI use in pregnancy and safest alternatives?
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How do we deal with these problems in our
practice?
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Difficult to identify in isolation

• Consider need for therapy
• Consequences of not treating
• Tetratogenicity of medication
• ADEC category of the drug

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ADEC Pregnancy Categories

• A Taken by a large number of pregnant women
  without ANY PROVEN increase in the frequency of
  malformations or other direct harmful effects of
  fetus
• B Taken by only limited numbers of pregnant
  women, without an increase in frequency of
  malformations etc
• and WRT animal studies
• B1 Animal studies show no evidence of fetal
  damage
• B2 Inadequate but show no evidence of fetal
  damage
• B3 Have shown evidence of increased occurrence
  of fetal damage, but human significance uncertain
• C Suspected of causing harmful effects BUT NOT
  MALFORMATIONS in HUMAN FETUS may be REVERSIBLE.
• D Suspected or expected to cause an increased
  incidence of HUMAN FETAL MALFORMATIONS or
  IRREVERSIBLE DAMAGE.
• X High risk of permanent damage in the fetus

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Where do you go for information?

• AMH? Listed under general information at the
  beginning of drug group not under each individual
  drug.
• MIMS under each drug and eMIMS lists experience
  how it was used

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Therapeutic Guidelines

• There has been concern about the safety of
  selective serotonin reuptake inhibitors (SSRIs)
  in pregnancy and data are lacking for the other
  newer antidepressants.
• As a result of this, tricyclic antidepressants
  (TCAs) are sometimes considered the drugs of
  choice in pregnancy.

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SSRI- areas of concern

• Teratogenicity
• Spontaneous abortion
• Premature labour
• Low birth weight/small-for-dates
• Poor neonatal adaptation
• Persistent pulmonary hypertension in the neonate
• Neurodevelopmental difficulties in older
  children. Potential problems have been reported
  with use of paroxetine and fluoxetine

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Information for health professionals concerning
use of SSRI antidepressants in pregnant women 7
September 2005 New information has recently
become available that suggests an association
between use of SSRI antidepressant medicines in
early pregnancy and congenital heart
abnormalities. This association appears to be
strongest for paroxetine.
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SSRI in pregnancy

• Exposure of infants during the first trimester of
  pregnancy is generally safe to the fetus small
  increased risk birth defects
• Most safety data is available for fluoxetine and
  sertraline
• Paroxetine in some studies shows higher risk
  cardiovascular malformations
• SSRIs may cause neonatal complications during 3rd
  trimester
• Serious adverse effects PPHN reported-rare

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Selection of medication

• Prior response (family history response)
• Anticipated efficacy and response
• Side effect profile individual
• Concurrent medications/ interactions
• Adverse effects medication
• Plans to breastfeed

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SSRIs in post natal/ breastfeeding

• Low levels SSRIs found breast milk
• Sertraline and paroxetine 1st line
• Monitor infant sleep / feeding/ irritability
  problems
• Greater risk in younger/ premmie babies
• Minimise exposure by spacing drug/ feeds

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References

• Depression in Pregnant Women. Up to Date version
  17.2 Jan 2009 available from http//www.utdol.com
  /home
• Information for Health Professionals Concerning
  the Use of SSRIs in Pregnant Women. Issued by
  TGA on 7th Sept 2005. www.tga.gov.au/alerts/ssri-h
  p.htm
• Briggs GG, Freeman RK, Yaffe SJ. Drugs in
  Pregnancy and Lactation- Eight Edition 2008.
  Lippincott, Williams and Wilkins.
• Alwan S, Reefhuis J, Rasmussen SA, Olney RD,
  Friedman JM. Use of selective serotonin-reuptake
  inhibitors in pregnancy and the risk of birth
  defects. N Engl J Med. 2007 Jun 28 356 (26)
  2684-92.
• Mothers milk. Pharmacy News. 2009 August 17-20