Paxil Heart Defects: Will Mothers Ever Be Sure?

Washington, DC"Now they're going to think for the rest of their lives that it was her fault because she took Paxil." Adrienne Einarson, semiretired assistant director of Motherisk in Toronto, was commenting on the debate that continues to boil surrounding antidepressants and pregnancy. Some studies have linked Paxil side effects and birth defects in babies. Other studies have been inconclusive. Still others have found no greater risk. Most find the risk to be small.

However, in 2011, a family won a Paxil lawsuit against the manufacturer of the SSRI antidepressant. GlaxoSmithKline was found by a trial jury to be negligent for failing to warn the mother of a child born with a Paxil heart defect—and her physician—regarding the risks associated with Paxil.

The settlement was worth $2.5 million to the family of the afflicted child.

There is no doubt about the popularity of selective serotonin reuptake inhibitor (SSRI) antidepressants. Since paroxetine (Paxil) was approved by the US Food and Drug Administration (FDA) in 1993, it has been elevated to herculean status as one of the world's most popular antidepressants.

There is also little doubt as to the effectiveness and need of SSRI antidepressants such as Paxil for individuals suffering from severe depression. However, on the other side of the issue, health advocates say that some doctors prescribe antidepressants too readily. Given the fact, according to Paxil manufacturer GlaxoSmithKline, that 25 percent of Paxil patients are women of childbearing age between 18 and 45, therein lay the dilemma—is it better to risk the emotional health of the mother, and by extension the child, by stopping an antidepressant? Or is it better to protect the mother's emotional health and accept the potential risk for Paxil birth defects?

That's the focus of a press report currently making the rounds of various newspapers and published most recently in the Press of Atlantic City, New Jersey, on April 30.

The report noted that women are conditioned to stop use of medication, and substances such as tobacco and alcohol upon learning they are pregnant. The problem, say advocates in favor of women maintaining their medication, are the risks associated with such a decision that could affect both mother and fetus. The effects of untreated depression on the baby can include low birth weight, irritability and developmental delays.

Advocates in favor of women maintaining their regimen of Paxil note that some studies have proven inconclusive, while others identify a minute risk of Paxil heart defects in the newborn—nor is it clear if defects are the result of medication, the depression itself or a combination of the two.

However, on the other side of the debate, researchers in Europe determined that a woman taking an SSRI antidepressant such as Paxil during the second half of her pregnancy more than doubles the risk for Paxil birth defects such as Persistent Pulmonary Hypertension of the Newborn (PPHN), a condition that can result in multiple organ damage and even death after the newborn cannot get sufficient oxygen into the bloodstream.

And while the risk is rare and study data inconsistent, that fact didn't stop the FDA from putting Paxil on its list of drugs suspected of causing Paxil defects.

"There's no path that's really risk-free," said Pec Indman, a San Jose, California-based therapist who specializes in perinatal mood and anxiety disorders, in comments published April 30 in the Press of Atlantic City. "Illness has risk, and treatment has risk."

Thus, the debate over the need to continue an SSRI such as Paxil to treat depression, v. stopping the medication or avoiding Paxil altogether to prevent potential Paxil side effects in the newborn, rages on.