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Scientists perfectly clear (again) on SSRI antidepressant fetal risks

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Replying to reader comments about their 2012 published study, Massachusetts-based researchers have reiterated in the April edition of the journal Human Reproduction three key findings about fetal exposure to selective serotonin reuptake inhibitor antidepressants.

Dr. Adam C. Urato of Tufts University School of Medicine and Dr. Alice D. Domar of both Harvard Medical School and Beth Israel Deaconess Medical Center stated in their letter that their scientific-literature review, the latter of which the journal accepted in September 2012, was indeed factual, not opinion-based. Further, they re-stated three points that their study validated.

The first of which is centered on the risks that an expectant mother’s use of SSRIs poses; the second goes to the lack of evidence linking prenatal SSRI use with “improved pregnancy outcomes”; and the third is the criticality of awareness of these facts among pregnant women, health care providers and the general public.

The SSRI class includes Zoloft, Paxil, Celexa, Lexapro, Prozac, Luvox and Viibryd.

The following is noted in the researchers’ original 2012 study’s results: “Antidepressant use during pregnancy is associated with increased risks of miscarriage, birth defects, preterm birth, newborn behavioral syndrome, persistent pulmonary hypertension of the newborn and possible longer term neurobehavioral effects. There is no evidence of improved pregnancy outcomes with antidepressant use.”

But when the evidence supports harm derived from an unreasonable risk about which the manufacturer failed to properly warn, the victims justly should be entitled to compensation.

SSRI complications can be fatal; if not fatal, then life-altering. Four of these increased risks, which the Massachusetts researchers analyzed, are examined here.

First, the authors referred to a 2006 study which estimated that as many as 30 percent of newborns exposed in utero to antidepressants suffer from newborn behavioral syndrome, which although generally characterized by relatively milder symptoms such as “crying, jitteriness and difficulty feeding,” also can be the more severe “seizures and difficulty breathing — sometimes requiring intubation.”

Second, referring to a 2011 Kaiser Permanente Northern California study, the physicians identified in their 2012 original report a more than two-fold “increased risk of autism spectrum disorders associated with maternal treatment with SSRI antidepressants during the pregnancy, with the strongest effect associated with treatment during the first trimester. No increase in risk was found for mothers with a history of mental health treatment in the absence of prenatal exposure to SSRIs.”

Third, the 2012 article further explained that there was evidence supporting as well as repudiating a connection between in-utero SSRI exposure and cardiac malformations; nevertheless “there has been a consistent ‘signal’ implicating SSRI use during pregnancy to various congenital anomalies.”

Ventricular septal defects and atrial septal defects have been among the congenital heart conditions associated with the expectant mother’s SSRI — notably Paxil — use.

Simple definitions of these conditions come from a venerable source. The American Heart Association in its February fact sheet describes VSD as “a hole in the wall separating the two lower chambers of the heart.” The association defines ASD as a “hole in the wall that separates the top two chambers of the heart.”

In a study not cited in the Human Reproduction piece, Dr. T.F. Oberlander and his colleagues at the University of British Columbia’s pediatrics department wrote in a 2008 article that infants exposed to a serotonin reuptake inhibitor as the sole drug therapy for certain maternal symptoms had an increased risk of ASD. That study appeared in Birth Defects Research, Part B, Developmental and Reproductive Toxicology.

Paxil (paroxetine) sustained a particularly hard lick. Observations about these heart malformations singled out Paxil. For instance, Urato and Domar last year pointed out how the U.S. Food and Drug Administration in 2005 requested that Paxil’s maker, GlaxoSmithKline, strengthen the drug’s warning. The new warning also would explain that these conditions may necessitate surgery.

Accordingly, GSK issued a statement to health care providers consistent with the 2005 amended warning. It read, in part, “Epidemiological studies have shown that infants born to women who had first trimester paroxetine exposure had an increased risk of cardiovascular malformations, primarily ventricular and atrial septal defects (VSDs and ASDs). … If a patient becomes pregnant while taking paroxetine, she should be advised of the potential harm to the fetus.”

Fourth, the researchers could not help noticing the elephant in the corridor of complications: persistent pulmonary hypertension of the newborn. A conspicuous blip on the FDA’s radar, the agency issued an advisory in July 2006 based on a study published in February 2006 in The New England Journal of Medicine.

“In this study,” the FDA’s nearly 7-year-old advisory read, “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.”

Additionally, the FDA “asked the sponsors of all SSRIs to change prescribing information to describe the potential risk for PPHN,” which it described as a “life-threatening lung condition that occurs soon after birth of the newborn.”

Life-threatening indeed. The current edition of a foreign medical journal says so. Based in Taipei, Taiwan, the April edition of the Journal of the Formosan Medical Association published a piece by two Medical College of Wisconsin professors that explained the origin and treatment of PPHN. It summarized the severity of PPHN.

“Persistent pulmonary hypertension of the newborn is a severe pulmonary disorder which occurs at a rate of one in every 500 live births,” reads the Formosan article written by Dr. Ru-Jeng Teng and Dr. Tzong-Jin Wu. “About 10-50 percent of the victims will die of the problem and 7-20 percent of the survivors develop long-term impairments such as hearing deficit, chronic lung disease, and intracranial bleed.”

Here is the kicker in regard to the potential finality of PPHN, in the words of these Wisconsin-based physicians: “Even with the introduction of several new therapeutic modalities there has been no significant change in survival rate.”

Urato and Domar covered a lot of ground in their review of scientific research. In the current month’s edition of Human Reproduction, they stand by their findings, reaffirming the veracity of their study’s conclusions about the link between fetal exposure to SSRI antidepressants and myriad increased risks.

The FDA has softened its stance on such a relationship, thus being receptive to studies to the contrary. Such neutrality means nothing to the victims.

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The pharmaceutical injury attorneys at Reich & Binstock have the unique experience and expertise which SSRI victims want in their pursuit of compensation. Anyone who may be suffering from Zoloft side effects or another SSRI injury, or who knows someone who may be, can contact the law firm toll-free at 1-866-LAW-2400 for a free attorney consultation. The law firm’s website is www.reichandbinstock.com.