By Sarah Mirando  |  April 8, 2013

Category: Pharmaceuticals
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FDA: Diabetes Now Among Birth Defects Caused by SSRIs

By Courtney Coren

 

Zoloft birth defectsOn February 1, 2013, the U.S. Food & Drug Administration (FDA) announced that “diabetes mellitus” would now be added to the warning label of the popular antidepressant Zoloft as another possible birth defect in children born to mothers who take the drug while pregnant.

On the warning label, diabetes mellitus is listed in the “Other Events Observed During the Post-marketing Evaluation” category. This means that, for now, Zoloft does not necessarily cause diabetes.

Zoloft and other antidepressants that are selective serotonin reuptake inhibitors (SSRI) such as Paxil, Celexa, Lexapro, Prozac, Luvox and Viibryd have already been linked to serious birth defects in the children of mothers who take them during pregnancy.

The New England Journal of Medicine published a study in 2006 showing that the risk for heart defects doubled in babies born to women who took Zoloft while pregnant. Another study published in the same journal showed that women who took Paxil during pregnancy had three times the risk of having a child born with heart defects over women who didn’t take the antidepressant.

Now, more possible birth defects are being linked to SSRI antidepressants. The Zoloft prescription guide now comes with a clear warning that “patients should be advised to notify their physician if they become pregnant or intend to become pregnant during therapy.”

The prescription guide also warns that “infants exposed to SSRIs in pregnancy may have an increased risk for persistent pulmonary hypertension of the newborn [PPHN]. PPHN occurs in 1-2 per 1,000 live births in the general population and is associated with substantial neonatal morbidity and mortality. Several recent epidemiologic studies suggest a positive statistical association between SSRI use (including Zoloft) in pregnancy and PPHN.”

The FDA describes PPHN as a “life-threatening lung condition that occurs soon after birth of the newborn.”

A study published in the New England Journal of Medicine (NEJM) in 2006 revealed that “PPHN was six times more common in babies whose mothers took an SSRI antidepressant after the 20th week of pregnancy compared to babies whose mothers did not take an antidepressant.”

In Zoloft and other SSRI birth defect lawsuits, those injured argue that the risk of these birth defects are unreasonable and that the pharmaceutical companies that make the SSRIs did not properly warn those who regulate, prescribe, dispense and take the drug.

One of the problems with several of the studies done on SSRIs is that they intentionally exclude women who are pregnant or who plan to become pregnant when there are clearly more studies that still need to be done on the effects of these anti-depressants on the children of mothers who take these drugs during pregnancy.

If you or anyone you know has had a child born with a birth defect as a result of taking an SSRI such as Zoloft, Paxil, Celexa, Lexapro or Prozac, legal options are available. Learn more and get a free legal consultation regarding a claim’s eligibility at the SSRI Antidepressant Birth Defect Class Action Lawsuit Investigation. Experienced legal professionals have access to medical experts to assess whether or not this antidepressant played a role in the development of a serious birth defect in your child, so act now.

 

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Updated April 8th, 2013

 

All medical device, dangerous drug and medical class action and lawsuit news updates are listed in the Drug and Medical Device section of Top Class Actions.

 

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