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SSRI Use Tied to Reports of Neonatal Withdrawal Symptoms


 

Of the 93 cases, 64 were associated with exposure to paroxetine, followed by 14 associated with fluoxetine (Prozac), 9 with sertraline (Zoloft), and 7 with citalopram (Celexa). Information on doses and duration of treatment during pregnancy were reported in a minority of cases.

The pharmacokinetic differences between SSRIs “could partly explain their different withdrawal effects,” they said.

For about a decade, there have been reports of withdrawal symptoms in newborns exposed in the third trimester to SSRIs. Symptoms have included irritability, abnormal crying, and difficulty feeding.

Acknowledging these reports, the Food and Drug Administration last year required manufacturers to add information to the labels of SSRIs and selective norepinephrine reuptake inhibitors (SNRIs), such as venlafaxine, on clinical findings in newborns exposed to these drugs late in the third trimester, including respiratory distress, jitteriness, irritability, hypoglycemia, feeding difficulties, and constant crying.

A spokesperson for Paxil manufacturer GlaxoSmithKline said the company had no statement on the Lancet report but pointed out that the FDA required this label change for all SSRIs and SNRIs.

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