SSRI impact could emerge in clinical trial

The results of a nearly completed clinical trial examining the prenatal effects of bupropion might also shed some light on the risks of exposing the fetus to a class of antidepressants known as selective serotonin reuptake inhibitors.

In the meantime, previous science shows that there is a heightened risk of birth defects in babies born to mothers who took SSRIs while they were pregnant. SSRI lawsuits are being filed across the country on behalf of victims whose congenital conditions reflect the unreasonable danger that the drug manufacturers either knew or should have known. The SSRI class of drugs includes Celexa, Lexapro, Paxil, Prozac and Zoloft.

GlaxoSmithKline makes Paxil and bupropion, marketing the latter as the brand name Wellbutrin. The drug maker is sponsoring the clinical trial, the Slone Epidemiology Center Birth Defects Study. The trial will observe data on newborns gathered at birth hospitals and at other health care facilities in Boston, Philadelphia, Toronto and San Diego through September 2013 in order “to identify the risks and safety of marketed drugs taken by pregnant women,” according to a summary of the experiment made available by the National Institutes of Health. A random sample of Massachusetts newborns without heart malformations also will be a data set.

Subjects who were interviewed as far back as 1992 will be included in the study.

Previous data suggested an increased risk of cardiac malformations in babies born to mothers who took bupropion while they were pregnant, according to the study’s summary, which added, “In 2008, the final report from the [b]upropion pregnancy registry described 24 congenital malformations among the 675 women exposed to bupropion in the first trimester of pregnancy.”

The ongoing clinical trial will evaluate discharge diagnoses and so on for newborns whose mothers fall into one of three categories:

• Exposure to any bupropion in the first trimester
• Exposure to bupropion alone during the first trimester
• No exposure to any antidepressant or smoking-cessation drug

There is a place in the trial in which exposure to Celexa, Lexapro, Paxil, Prozac or Zoloft might show up in the data. It is possible that the potential influence of SSRI exposure on congenital heart malformation will show up in reports from the first group of mothers.

As an explanation of the trial’s “intervention” reads, in that first group, “The use of bupropion in combination with other anti-depressants, exposure to SSRI anti-depressants, and exposure to non-SSRI anti-depressants, including tricyclic anti-depressants, during this time period will be explored.”

In the time being, Paxil lawsuits, Zoloft lawsuits, and the like are driven by the increased risk of birth defects in the children of mothers who took those drugs while they were pregnant.

Based on a pair of studies, the FDA on Dec. 8, 2005, announced that it had “determined that exposure to paroxetine (Paxil) in the first trimester of pregnancy may increase the risk for congenital malformations, particularly cardiac malformations.” The administration added that risk to the drug’s prescribing information.

On July 19, 2006, the FDA issued a public health advisory based on a study “focused on newborn babies with persistent pulmonary hypertension (PPHN), which is a serious and life-threatening lung condition that occurs soon after birth of the newborn.”

This is the FDA’s explanation of the defect: “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.”

The FDA revisited the SSRI birth defects matter on Dec. 14, 2011, at which time the administration announced that there was not enough scientific evidence on which to conclude that SSRI use during pregnancy causes PPHN.

Nevertheless, plaintiffs in SSRI lawsuits rise and sleep with all of the life-altering evidence they need. Those who are represented by the experienced pharmaceutical injury attorneys at Reich & Binstock rest assured that their litigators will fight for their just compensation.

The victimized children and their families face conditions that may require surgery or, at best, years of costly treatment. The medical expenses are not a family’s only losses linked to SSRI birth defects.

Each SSRI manufacturer had a duty to know and to inform the public and the medical profession about the heightened risks. Victims have a right to recover damages that such negligence gives rise to.

A lot of people in this unfortunate position are represented by the pharmaceutical personal injury attorneys at Reich & Binstock, who try cases nationwide. One may contact Reich & Binstock toll-free at 1-866-LAW-2400 for a free consultation.