FDA Warning
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The FDA is strongly considering revising the labels of all SSRI
antidepressants based on recent New England Journal of Medicine article. The
article links usage of antidepressants late in pregnancy with persistent
pulmonary hypertension (PPHN), a condition that can endanger infants' lives.
Persistent pulmonary hypertension (PPHN) is also referred to as persistent fetal
circulation. In this condition, a newborn baby's circulation changes back to the
circulation of a fetus, where much of the blood flow bypasses the lungs.
Generally, one to two newborns per 1,000 suffer from persistent pulmonary
hypertension. These infants have pulmonary arterial pressure that is too high at
birth. As a result, their lungs can't provide enough oxygen, which causes their
bodies to produce oxygen-poor blood, sometimes resulting in death. In one study,
nearly half the survivors were cognitively delayed, had major neurological
problems, and could not hear.
When pregnant women took selective serotonin reuptake inhibitors after 20 weeks
of conception, the risk of their infants developing persistent pulmonary
hypertension rose sixfold, to about 1 in 100 newborns. The study size was too
small to determine whether one antidepressant was riskier than another. Dr.
James Mills of the National Institutes of Health commented in an editorial that
this is the latest in a series of troubling reports of possible adverse effects
of elective serotonin reuptake inhibitors (SSRIs) on developing fetuses.
The following are the most common symptoms of persistent pulmonary hypertension.
However, each baby may experience symptoms differently. Symptoms may include:
• cyanosis (blue coloring)
• baby appears ill at delivery or in first hours after birth
• rapid breathing
• low blood oxygen levels while receiving 100 percent oxygen
• rapid heart rate
The FDA previously warned of a connection between Paxil, a popular
antidepressant, and heart defects when the drug is taken early in pregnancies.
The study described in the Journal article was observational and included
interviews with 1,200 women within six months of giving birth.
Find out more about... FDA Warnings |
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