Paxil, Pregnancy and Birth Defects

Newfoundland, PA"My psychiatrist prescribed Paxil when I was three months pregnant," says Jaime Curtis. "I feel like it is my fault that I did this to my kid; it just breaks my heart when he can't breathe." Jaime was never told about Paxil's link to birth defects.

"I had a normal pregancy, just like my other two, and Geoni was born just five days before my due date. But I couldn't hold him for the first three days - they put him in ICU right away and he was in this incubator with lots of tubes and machines whirring around him. I fed him through a breast pump and after a few days (I was sleeping on a couch in the ICU waiting room) they would call me on a bell to alert me when he was hungry. The nurse would place him on my lap and I could finally breast feed Geoni but I still couldn't hold him because he was hooked up to a machine.

This went on for about a week and all the doctors told me was that he was stressed from the birth. When we finally left hospital I had to keep him hooked up to a breathing monitor at home. I took him to my family doctor for his first check-up; it would have been about a few days after we got home. My doctor diagnosed him with a heart murmur; why hadn't I been told this earlier, at the hospital? This obviously explained his breathing problems.

But it wasn't just a slight murmur - my doctor immediately referred him to a pediatric specialist at the hospital in Hershey. There he was hooked up to yet another machine that produced a picture of his heart and the specialist showed me two holes in between the two heart chambers. I panicked; I thought he was going to die!

But the doctor calmed me down and told me that it should close and the louder the murmur, the smaller the hole and it should go away by the time he is six months old.

Geoni is now two years old and the holes are still there. If he plays tag with the other kids, his face goes beet red and he has to stop and catch his breath. I can hold him close to me and hear a swishing sound - I can hear his heart murmur.

I never knew the dangers of Paxil until Frank, my husband, saw it on the news last week. I am still taking Paxil and nobody, not even my family doctor, has mentioned it. I even asked my psychiatrist if it was safe to take while I was pregnant! I went to the prenatal clinic as soon as I was pregnant and they have my medical records; I told them at the first visit that I was taking Paxil. When I first started taking it, I was only prescribed 10 mg then my psychiatrist increased the dosage to 30 mg.

This is really screwed up. My kid could suffer because of this. I just hope he is going to be OK. Did the makers of Paxil know about this all along and these side effects were covered up? Now I see it on the Internet and I can't believe it. I feel like it is my fault that I did this to my kid; it just breaks my heart when he gets out of breath. If I didn't take Paxil I know he would be fine just like my other two kids. [GlaxoSmithKline] should pay for what they have done. What about all the kids who need surgery? The specialist has told me that, when my son gets bigger he is going to need surgery because his heart will not be able to handle the pressure. I don't know how I am going to afford this."

On December 8, 2005, the Food and Drug Administration (FDA) warned pregnant women and their doctors away from the antidepressant Paxil because of an increased risk of heart defects in newborns. Although the FDA did not say that Paxil could never be used by pregnant women, it advised patients that Paxil "should usually not be taken during pregnancy."

"If you're on Paxil and pregnant, our advice is to talk to your physician and consider switching to a different drug," said Robert Temple, the FDA's director of medical policy. "Abrupt withdrawal of Paxil has its own problems, but the clear suggestion here is that you might want to think about a change."

Just one month later, The FDA stepped up warnings that paroxetine (under the trade name Paxil) increases the risk of congenital defects, especially cardiovascular malformations. GlaxoSmithKline and the FDA agreed that paroxetine should be reclassified on its labeling from a pregnancy category C to a D. The D designation indicates "that studies in pregnant women have demonstrated a risk to the fetus," the agency said in a statement. According to Dr. Hughes at the FDA, these warnings won't be the last, and he said the agency expects more data in late 2006. "It is possible that further labeling changes will be necessary," she said.