Playing Solomon over Paxil Birth Defects

Washington, DCThe choosing between Paxil side effects, and the potential effects of stopping the SSRI medication to avoid such adverse reactions, is a debate that never gets easier over time. However, the factual tone of a recent edition of FDA Patient Safety News, a regular video feed released under the auspices of the US Food and Drug Administration (FDA), comes short of reflecting the emotional turmoil that often accompanies such a decision.

Various studies were made involving selective serotonin reuptake inhibitors (SSRI) and pregnant women, or women who were planning on becoming pregnant. Specifically, women who had a history of depression were five times more likely to suffer a relapse of their depression if their SSRI (such as Paxil) was stopped, than those women who continued their SSRI regimen.

Not surprisingly, the FDA strongly advised SSRI patients planning on becoming pregnant to consult their doctor prior to taking any action.

The second study, articulated in a similarly clinical tone, noted that infants borne to women who continued to use an SSRI like Paxil beyond the 20th week of gestation exhibited a six-fold increased risk for persistent pulmonary hypertension of the newborn (PPHN). The latter has been described as being associated with a series of Paxil birth defects.

"PPHN is a life-threatening condition that becomes evident soon after birth and occurs in about one, to two per-thousand births in the US," states the correspondent in the video. The video further explains that infants suffering from PPHN become hypoxemic because of abnormal blood flow through the heart and lungs.

"The possible risk of PPHN adds to concerns raised in other reports that infants of mothers who take antidepressants late in pregnancy may experience problems such as irritability, difficulty in feeding, and in rare cases difficulty in breathing.

"And the labeling for Paxil now cautions that exposure during the first trimester could be associated with an increased risk of cardiac anomalies in the newborn."

In other words, Paxil heart defects.

An accompanying statement by another reporter in the video underscores the need to weigh the risk of [depression] relapse if medication is discontinued during pregnancy, against the risk for rare, "but serious adverse affects in her infant, if she continues to take the drug."

Not mentioned in the video is any reference to the potential for an unplanned pregnancy. Beyond the debate as to whether or not it may be prudent to stop Paxil and risk harm to the mother v. continuing and risking harm to the infant is when the capacity for even making a decision is compromised by an unplanned pregnancy—in some cases, a pregnancy that sneaks up on a woman who may be unaware of the pregnancy until she is well on.

One wonders if the Paxil FDA decision that preceded the introduction of Paxil to the market in 1993, involved discussion related to this issue. Many a Paxil lawsuit may suggest otherwise.