Concern Over Possible SSRI Birth Defects Certainly Not New

Washington, DCWhile concern over the potential for SSRI birth defects has been growing, the issue is far from new. And while the US Food and Drug Administration (FDA) released its most recent statement with regard to SSRI antidepressants in 2011, suspicion that either one SSRI in particular or all SSRI drugs in general carrying potential for serious, but rare abnormalities, goes back even longer.

Selective serotonin reuptake inhibitors (SSRIs) are a relatively newer class of antidepressants found to be more effective at treating depression than an older class of drugs. Speculation abounds that this may be one of the reasons behind a massive spike in SSRI use amongst women. LawyersandSettlements.com writer Brenda Craig, writing in Antidepressants in Crosshairs As Mother’s Class Action Moves Forward, cited a data brief published by the US Department of Health and Human Services that reported a 400 percent increase in the use of antidepressants in the US. Furthermore, it is estimated that a staggering 11 percent of women take an antidepressant, with 13.4 percent of all pregnant women in the US actively using an antidepressant during pregnancy.

Whether or not those antidepressants were latest-generation antidepressants that appear to put patients at risk for SSRI side effects was not broken out. But it’s safe to assume that SSRI effectiveness, availability and the willingness of doctors and psychiatrists to prescribe them, place selective serotonin reuptake inhibitors near the very top.

As for the FDA, the federal agency responsible for the regulation of drugs in America had this to say, on December 14, 2011…

“The U.S. Food and Drug Administration is updating the public on the use of selective serotonin reuptake inhibitor (SSRI) antidepressants by women during pregnancy and the potential risk of a rare heart and lung condition known as persistent pulmonary hypertension of the newborn (PPHN). The initial Public Health Advisory in July 2006 on this potential risk was based on a single published study. Since then, there have been conflicting findings from new studies evaluating this potential risk, making it unclear whether use of SSRIs during pregnancy can cause PPHN.”

The FDA, in its statement, referenced a previous public health advisory from 2006. But the concern goes back even further when, according to a published report from WebMD (9/24/09), the FDA singled out Paxil for an increased risk for heart defect in newborns in 2005. The cautionary stance from the FDA was based on research that had just been published at the time.

Such research takes years to conceive, undertake, compile and complete - which puts the timeline for concern over the potential for SSRI birth defects back even further. At the time, a Danish study suggested that two SSRI drugs in particular, taken early in pregnancy, were found to be associated with a small increased risk for heart defect. For purposes of the study, the offspring of Danish women who took SSRI drugs in their first trimester were compared to that of women who did not use SSRI drugs. Some 400,000 infants born between 1996 and 2003 were studied.

Thus, researchers are closing in on 20 years since someone in a lab or university somewhere first hypothesized the possibility of a link between SSRI antidepressants and SSRI birth defects.

And yet, we seem no further ahead. Despite the FDA’s cautionary stance in 2011 and the growing concern over SSRI side effects, all agree that more studies need to be done to add some conclusiveness to the concern - conclusions that would help pilot the ongoing debate as to whether or not SSRI antidepressants should be stopped when a woman is pregnant, planning to become pregnant or suddenly discovers she is pregnant in an unplanned capacity (by then, for the unborn infant, it may be too late).

Women’s health advocates cite concern for the mother if SSRI drugs are stopped. Pediatric advocates push forward the position that stopping the medication, temporarily during pregnancy, is the only way to effectively mitigate any risk to the fetus.

While American women wait for larger and more conclusive studies to help crystalize the SSRI debate, heartbroken parents continue to file an SSRI lawsuit after their newborn comes into the world with PPHN or other SSRI birth defects. PPHN makes it extremely difficult for an infant to make the transition to breathing outside the womb, with some struggling valiantly in the delivery room to survive. Many do. Others have lived for only a few hours or a few weeks before succumbing to PPHN.

In the meantime, combined with the concern over the prevalence of selective serotonin reuptake inhibitors, is the apparent rush to prescribe them for even low incidence of depression. University of British Columbia researcher and pharmacologist, Dr. Barbara Mintzes, was quoted by writer Brenda Craig as saying, “The majority of women are prescribed SSRIs for mild to moderate depression.” The suggestion, therefore, is that other treatment options that could hold promise as effective are being cast aside in deference to the convenience of a prescription.

But as many an SSRI lawyer can attest, the cost of that convenience can be devastating.

The first bellwether cases alleging that Zoloft and other selective serotonin reuptake inhibitors cause birth defects are scheduled for the fall of next year.