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Paxil, Prozac birth defects link studied (Zoloft, other SSRIs not off the hook)

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“It has been suggested that the commonly prescribed class of antidepressants selective serotonin reuptake inhibitors are associated with birth defects,” and Prozac and Paxil are more strongly associated with the more serious conditions, according to a comparison of SSRI side effects risks that The Australian and New Zealand Journal of Psychiatry will publish.

Among the children of women who used this class of drugs while they were pregnant, Prozac (fluoxetine) and Paxil (paroxetine) were linked to an increased risk of “major malformations,” according to this study, and Paxil was singled out for its increased risk of “cardiac malformations.” (Sarafem and Symbyax also are fluoxetine-containing SSRIs, according to the U.S. Food and Drug Administration.)

There are several types of major malformations. The FDA categorizes neural tube birth defects, craniofacial defects and cardiovascular malformations among major birth defects. Neural tube birth defects, according to the Code of Federal Regulations, “are serious birth defects of the brain or spinal cord that can result in infant mortality or serious disability” and include anencephaly and spina bifida.

The Australian and New Zealand study consisted of an analysis of more than 100 other studies and of the dozens of data sets they spawned.

The whole SSRI lot already has been collectively linked to a serious newborn lung condition.

The FDA in July 2006 issued a public health communication explaining that the agency “asked the sponsors of all SSRIs to change prescribing information to describe the potential risk for PPHN,” persistent pulmonary hypertension. The move was based on a study published in February of that year in The New England Journal of Medicine that showed “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.”

“PPHN occurs when a newborn baby does not adapt to breathing outside the womb,” the FDA wrote in a 2011 statement that cited “conflicting findings” on the increased risks of neonatal SSRI side effects. “Newborns with PPHN may require intensive care support including a mechanical ventilator to increase their oxygen level. If severe, PPHN can result in multiple organ damage, including brain damage, and even death. … Secondary PPHN may be associated with other problems with the fetus, such as meconium aspiration, neonatal infection or congenital heart malformations.”

In addition to Paxil, Prozac and the other fluoxetine-containing prescription medications, the SSRI class includes Zoloft, Celexa, Lexapro, Luvox and Viibryd.

None of these drugs is off the hook from a side effects standpoint, and recent science bears that out. For instance, a Swedish study published this spring showed that in-utero exposure to selective serotonin reuptake inhibitors “was associated with an increased risk of autism spectrum disorders.”

A study published in late 2012 in the journal Therapeutic Drug Monitoring also specified birth defects under SSRI side effects. In-utero Zoloft exposure, for example, was cited in this study for its increased risks of “omphalocele, anal atresia, limb-reduction defects, cardiac septal defects and anencephaly.”

Is there any wonder there are Zoloft class action lawsuits in assorted SSRI litigation? The manufacturers — including Pfizer in the case of Zoloft and GlaxoSmithKline for Paxil — should have known about the increased risks of their drugs and should have done more, and should have done it faster, to protect patients from those risks, victims may assert in pharmaceutical injury lawsuits.

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The experienced pharmaceutical injury attorneys at Reich & Binstock want to help the victims of prenatal SSRI exposure and their families. A Reich & Binstock attorney will investigate the potential entitlement to compensation free of charge for anyone who requests a free consultation. The law firm, which operates in every state, may be reached toll-free at 1-866-LAW-2400 or online at www.reichandbinstock.com.