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Home / FDA on Antidepressants

FDA on Antidepressants

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The Food and Drug Administration has updated its position on selective serotonin reuptake inhibitor antidepressant medications (SSRI’s). The safety announcement was released on December 14, 2011. The FDA updated a Public Health Advisory initially released in July 2006. In the latest announcement, the FDA stated that new study results were conflicting. Therefore, it is premature to reach any conclusion about a possible link between SSRI use during pregnancy and PPHN in newborns.

PPHN can be a serious birth defect. It occurs when a newborn baby does not adjust to breathing outside the womb. PPHN can result in multiple organ damage, brain damage, and sometimes death. Two studies have, according to the announcement, found a statistically significant association between antidepressant use and PPHN in newborns. Three other studies have found no statistically significant increase of this rare birth defect. All five studies used different designs and different methods. As a result the FDA advises health care professionals to treat depression during pregnancy as clinically appropriate.

SSRIs are marketed under several brand names including Celexa, Lexapro, Prozac, Paxil, Zoloft, and Luvox. They go by the generic names Citalopram, Escitalopram, Fluoxetine, Fluvoxamine, Paroxetine, Sertraline, and Vilazodone. They are primarily used for treating depression.

If you believe your child’s birth defect may have been caused by a medication you were taking, call Longo Legal, PLLC and let’s talk about your legal options.

Source: FDA Drug Safety Communication: Selective serotonin reuptake inhibitor (SSRI) antidepressant use during pregnancy and reports of a rare heart and lung condition in newborn babies, 12/14/11.

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