Father Wonders if Paxil caused Two Holes in Daughter's Heart

Lebanon, INMark's daughter was born with two holes in her heart. Although his wife was not taking Paxil during her pregnancy, he was. He wonders if the heart defects, which match the Paxil-related birth defects, may be related to his use of the antidepressant. He can find no other plausible explanation.

Mark has depression, and his doctor prescribed the selective serotonin receptor inhibitor (SSRI) Paxil, also called paroxetine, in the hope that it would help. Mark had been taking the drug for about 3 months when his wife became pregnant. "I started taking Paxil around April 2005, and our daughter was conceived in August," Mark said.
The pregnancy appeared to be going smoothly until an ultrasound showed that the fetus had a pinched aorta. The doctors didn't seem unduly alarmed however they did continue to monitor the situation. As the pregnancy continued and the doctors monitored the baby's aorta, another defect showed up. She had developed 2 holes in her heart.

While Mark understands that so far doctors believe that foetuses are exposed to Paxil through the mother, he can't help wondering if Paxil could be transmitted through the sperm as well. "I've been told it has to be the mother taking it because it's in the blood stream," he said." But if it's in the sperm –surely it could have some effect? It seems reasonable to me. A possible connection didn't even enter my mind until I saw the ads on TV. That was about 6 months after my daughter was born. Neither my wife nor I have any personal or family history of genetic abnormalities, nor anything to indicate that there could be problems that would lead to birth defects."

Mark saw the ads on TV in the fall of in 2006. In December 2005 the first public warnings emerged from the federal Food and Drug Administration (FDA) about the potential for serious heart defects in babies born to women taking Paxil during their pregnancies.

The warning was based on data from 2 studies which showed a 1.5 to 2 times increased risk of giving birth to a child with a heart defect compared with pregnant women not taking the anti-depressant. In addition to the warning, the FDA actually placed Paxil in its second highest category for risk of birth defects, advising patients that "this drug should usually not be taken during pregnancy."

In a later warning, the FDA said that Paxil "should generally not be initiated in women who are in their first trimester of pregnancy or in women who plan to become pregnant in the near future."

At this point Paxil had been on the market for 13 years – it was approved as an antidepressant in 1993. Paxil is among most heavily prescribed antidepressants on the market.

Not surprisingly, Mark has stopped taking Paxil, something he didn't find easy. "Coming off Paxil felt like I had the flu for 2 weeks. I felt terrible, it scared me. And it makes me think twice about taking any medication because it make take years before any potential side effects or problems are discovered with any drug – not just Paxil – and by then it's too late. " Certainly it's too late for his daughter.