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FDA Public Health Advisory
Treatment Challenges of Depression in Pregnancy and the Possibility
of Persistent Pulmonary Hypertension in Newborns
List of Drug
Names
Decisions about how to treat depression in pregnant
women are increasingly complex. Patients and physicians must
carefully consider and discuss together the potential benefits and
risks of treatment with antidepressants during pregnancy. Two new
studies provide important information to be considered in making
such decisions. The studies included women who had been treated with
antidepressant drugs that act as selective serotonin reuptake
inhibitors (SSRIs) or, in a few cases, other antidepressants. SSRI
medications are the most commonly used drugs to treat depression in
the U.S.
The first study illustrates the potential risk of relapsed
depression after stopping antidepressant medication during
pregnancy. The authors followed pregnant women who in the past had
major depression. During their pregnancy, some of these women were
not feeling depressed and stopped taking their antidepressant
medicines. Others stayed on their antidepressant medicines while
pregnant. The women who stopped their medicine were five times more
likely to have a relapse of depression during their pregnancy than
were the women who continued to take their antidepressant medicine
while pregnant. This study, by Lee Cohen and other authors, was
published February 1, 2006 in the Journal of the American Medical
Association (JAMA).
A second study suggests there may be additional, though rare, risks
of SSRI medications during pregnancy. This study focused on newborn
babies with persistent pulmonary hypertension (PPHN), which is a
serious and life-threatening lung condition that occurs soon after
birth of the newborn. Babies with PPHN have high pressure in their
lung blood vessels and are not able to get enough oxygen into their
bloodstream. About 1 to 2 babies per 1000 babies born in the U.S.
develop PPHN shortly after birth, and often they need intensive
medical care. In this study PPHN was six times more common in babies
whose mothers took an SSRI antidepressant after the 20th week of the
pregnancy compared to babies whose mothers did not take an
antidepressant. The study was too small to compare the risk in one
drug compared to another, and this risk has not so far been
investigated by other researchers. The study, by Christina Chambers
and others, was published on February 9, 2006 in The New England
Journal of Medicine.
The finding of PPHN in babies of mothers who used a SSRI
antidepressant in the second half of pregnancy adds to concerns
coming from previous reports that infants of mothers taking SSRIs
late in pregnancy may experience difficulties such as irritability,
difficulty feeding and in very rare cases, difficulty breathing. In
addition, the labeling for paroxetine (Paxil) was recently changed
to add information about findings in an epidemiology study
suggesting that exposure to the drug in the first trimester of
pregnancy may be associated with an increased risk of cardiac birth
defects (see FDA Public Health
Advisory for Paxil dated December 8, 2005).
The uncommon potential risk to the newborn of PPHN has not been
confirmed by additional studies. Uncertainty about these rare events
and their potential impact on the newborn, along with the potential
risk to the mother of recurring depression if she stops her
antidepressant medicines during pregnancy, makes decisions about the
treatment of depression in pregnant women especially challenging for
health care professionals and patients.
Women who are pregnant or thinking about becoming pregnant should
not stop any antidepressant without first consulting their
physician. The decision to continue medication or not should be made
only after there has been careful consideration of the potential
benefits and risks of the medication for each individual pregnant
patient. If the decision is made to stop treatment with SSRIs before
or during pregnancy, this should be done with a healthcare
professional, according to the prescribing information for the drug,
and patients should be observed closely in case their depression
comes back.
The FDA is seeking additional information about the possible risk of
PPHN in newborn babies of mothers who took SSRI antidepressants in
pregnancy. In the meantime, the FDA has asked the sponsors of all
SSRIs to change prescribing information to describe the potential
risk for PPHN. Prescribing information will be updated with
information from additional studies when this information becomes
available.
SSRIs and a Combination
Drug Containing an SSRI
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Date created: July 19, 2006 |
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