Paxil Birth Defect Warnings too Late For Two Little Boys

Hendersonville, NCApril has 3 children; 2 were born with complications, quite possibly Paxil-related birth defects. April had taken the selective serotonin re-uptake inhibitor (SSRI) Paxil, also known as paroxetine, during both pregnancies.

"Christian, my first son, was born 4 weeks early, and his brother Jordon was born 6 weeks early – both babies were premature," April said. Christian was born in January 1998, and he was born with a heart murmur – or a hole in his heart. "I was suffering from depression when I became pregnant with Christian. I asked my doctor if it was safe to take the antidepressant while I was pregnant and he assured me that yes, it was totally safe. The doctors found my son's heart murmur within a day or two of his birth."

Jordon, April's second son, was born in 1999. "When he was born the doctors thought he'd had a seizure because he sweated profusely, which is odd for a newborn," April said. "And he had a twitch in his leg. These symptoms were all considered to be neurological. But after they did all the appropriate tests, they couldn't find anything that indicated what was going on. It wasn't until he was about 18 months old that I noticed that he wasn't talking. In fact, Jordon didn't start talking until he was 5. He still has developmental issues. We've had him tested. Autism has been ruled out, but his verbal communication skills have been slow to develop. He went to a special pre-school, and is in special classes now. He's in the 4th grade, and is still having speech therapy.

We had him tested when he was young, but they couldn't determine what was going on, and the doctors still don't know. Nobody has ever been able to tell me why this has happened, or what it is he actually has. I really wonder if Paxil had an effect on both of my children while I was pregnant. I saw the commercials that talked about the birth defects associated with taking Paxil during pregnancy, and they sounded very similar to what we're experiencing. I went online and did some research and I think it may be possible."

What the Studies Say About Paxil and SSRI Birth Defects

Unfortunately, it wasn't until 2005 that the Food and Drug Administration (FDA) issued a public health warning regarding Paxil. The warning was based on findings from 2 now very well known studies which showed an increased risk for birth defects in babies born to women taking the drug during pregnancy. In fact, the studies showed a 1 to 2 times greater risk of having a baby with a heart birth defect while on Paxil. In conjunction with the warning, the FDA placed Paxil in its second highest category of drugs known to cause birth defects.

Most recently, a study published in the November 2008 issue of the British Journal of Clinical Pharmacology, reported a 3 times greater risk for heart defects in babies born to mothers taking either Prozac (fluoxetine) or Paxil. The study looked at babies born to 800 women who said they took either drug during the first trimesters of their pregnancies. Comparison was then made to 1,400 expectant mothers who were not on antidepressants of any kind.

In fact, birth defects are associated with a number of SSRI antidepressants, namely Zoloft, Celexa, and Lexapro, in addition to Prozac and Paxil.

Too Late For Some, But Not All

But for all the good these warnings may be doing, they came too late for April, Christian and Jordon. Some good news, however, is that Christian's heart murmur resolved itself after a year. But for Jordon, the problems continue, and will likely last his lifetime.
April wishes the information on SSRI birth defects had been public when she became pregnant, and that is part of the reason she is sharing her story now, as a warning to women who may still be unaware of the dangers.