Can’t simply dismiss antidepressants-birth defects link

An issue in pharmaceutical injury lawsuits, there is a plausible relationship between birth defects and fetal exposure to selective serotonin reuptake inhibitor antidepressants. That is a reasonable corollary of a 2012 study conducted by Dr. Heli Malm, head of the Teratology Information Service at Helsinki University Central Hospital. The findings of her comprehensive analysis of completed research were published in the December (and January) edition of the Therapeutic Drug Monitoring journal.

Calling for additional research that should be centered on long-term neurodevelopmental consequences, Malm concluded, “Causality cannot be confirmed in observational study settings. However, parallel results in individual studies regarding the cardiac malformations and pulmonary hypertension of the newborn, together with an existing biologically plausible mechanism behind these events, may support causality.”

Based on a February 2006 study published in The New England Journal of Medicine, the U.S. Food and Drug Administration “asked the sponsors of all SSRIs to change prescribing information to describe the potential risk for PPHN,” which is persistent pulmonary hypertension. An FDA public health advisory issued in July 2006 described PPHN as a “life-threatening lung condition that occurs soon after birth of the newborn.”

The advisory further explained, “Babies with PPHN have high pressure in their lung blood vessels and are not able to get enough oxygen into their bloodstream. About 1 to 2 babies per 1,000 babies born in the U.S. develop PPHN shortly after birth, and often they need intensive medical care. In this study 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.”

In the meantime, the pharmaceutical injury attorneys at Reich & Binstock — in Zoloft lawsuits, Paxil lawsuits and the like — have been representing victims of the increased risk of SSRI-associated neonatal malformations. In a free consultation, a Reich & Binstock personal injury attorney can examine the circumstances of anyone who feels likewise injured and can accordingly explain what the damaged party’s options may be. It costs nothing to have an experienced Reich & Binstock attorney look into whether one is entitled to compensation.

Regardless of one’s state of residency, there are two ways to get the process started. Submit an electronic request for free legal advice through Reich & Binstock’s Web site, www.reichandbinstock.com, or call the law firm toll-free at 1-866-LAW-2400.

In addition to Zoloft and Paxil, the SSRI class includes Celexa, Lexapro, Prozac, Luvox and Viibryd.

Experimental outcomes were mixed, but the Therapeutic Drug Monitoring piece noted the following findings from some, not all, of the research:

• Zoloft: Increased risks of “omphalocele, anal atresia, limb-reduction defects, cardiac septal defects and anencephaly.”

• Paxil: “[O]f the individual SSRIs, prenatal exposure to paroxetine has most often been associated with cardiovascular malformations.”

• Celexa: Some data showed that “citalopram use in early pregnancy was associated with septal heart defects.”

• Prozac: Evidence of an “increased risk of cardiovascular malformations, and more specifically ventricular septal defects,” exists.

Backing away a little from its 2006 advisory, the FDA cited “conflicting results from different studies” concerning the SSRI-birth defects link, adding, “FDA will update the SSRI drug labels to reflect the new data and the conflicting results.”

The recently published Malm study, which cited research that “may support causality,” is relatively “new data” that the FDA can use.