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Birth Defects Caused by Paxil

Generic: Paroxetine
Approved to treat: Major depression, Obsessive Compulsive Disorder and Post-traumatic Stress Disorder
Drug category: Selective serotonin reuptake inhibitor (SSRI)
Pregnancy risk: Category D (Positive evidence of risk)
Year approved: 1992
Manufacturer: GlaxoSmithKline

Paxil birth defectsBabies who are prenatally (before birth) exposed to Paxil are exposed to a variety of life-threatening birth defects. According to studies, taking certain SSRIs during pregnancy can result in risks as high as the following:

Multiple Studies Find Link Between Anti-Depressant Exposure and Birth Defects

Considerable research, including two studies published in the February 2006 issues of the New England Journal of Medicine and two studies published in the Journal of the American Medical Association (JAMA) have indicated an increased risk of birth defect for babies exposed to anti-depressants such as Paxil before birth. The JAMA study showed that women taking certain SSRIs within the first 20 weeks of their pregnancy are 6x more likely to have a baby with PPHN.

The FDA required Paxil to update its label in December 2005 because various studies at the time showed that women who use SSRIs such as Paxil in the early stages of pregnancy have an increased risk of having a baby born with a heart defect. The FDA also required GlaxoSmithKline to move Paxil from a Category C to Category D drug because of these potential risks of birth defects.

While the risk varies for each defect, one thing is clear: women should be warned of these dangerous and potentially fatal side effects before becoming pregnant. Unfortunately, the manufacturers of SSRI anti-depressants are not currently required to warn users of these increased risks and, as a terrible result, babies continue to be harmed.

Latest News Regarding Paxil

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