Paxil Category Warning too late for my Baby

"This is what I want to say to GlaxoSmithKline, the manufacturers of Paxil: How can you let money come before people's lives and well-being and have no conscience?"

In 2001, 22-year-old Nancy Jones went to a mental health clinic to seek treatment for anxiety and depression and was prescribed Paxil. Unfortunately, Jones didn't know that she was three months pregnant.

"As soon as I found out that I was pregnant I went back to the clinic," says Nancy Jones (not her real name pending a lawsuit). The doctor told me to drop the dosage from 40 mg to 20 mg; it was helping my anxiety and depression so I just continued taking it. He explained to me that Paxil is considered a 'category 3', which meant that, as far as pregnancy goes, the side effects are inconclusive but there are no long-term dangers. I looked up Paxil in the Merck manual but the information was murky.

In December 2005, "asked" Paxil manufacturer Glaxo Smith Kline (GSK), to change the pregnancy category from C to D, a stronger warning. Category D means that studies in pregnant women (controlled or observational) have demonstrated a risk to the fetus.

"I was on Paxil throughout my pregnancy. When I was eight months pregnant I noticed that my baby stopped moving. I called the doctor and he told me to come into his office. They tested his heartbeat and did an ultrasound and said I was having contractions. They sent me to the hospital and kept me overnight. The next day I had another, in-depth ultrasound where they measured my baby and told me that his head was slightly enlarged. I was hooked up to the monitor and his heartbeat was higher than normal, like he was running, but he was at rest. His heartbeat was elevated but they couldn't figure out why. I was discharged from the hospital as 'high risk' and had to go back twice a week until I had the baby.

Just two weeks later, the same thing happened again - he stopped moving. That Friday I went back to the hospital, they hooked us up to the monitor and said the baby was fine, although his heartbeat was still elevated. So I went back to work on Saturday night - I was a waitress. On Monday afternoon I went to my doctor for a regular check-up and he couldn't find a heartbeat. I went to the ultrasound room and it confirmed that my son was dead. It was January 24th, 2001.

They made me deliver the baby normally and didn't put me in the hospital until Tuesday night. I carried him for two days, knowing he was dead. I had an autopsy done - one of Paxil's side effects is an enlarged heart and this was found in my son. Your heart develops in the first three months and I didn't reduce my dose until after my first trimester. 40 mgs was a lot to take but at the time, I thought more would be better.

I know that Paxil did it. I searched for information about Paxil and pregnancy and didn't find anything until last December, 2005. I saw all these bulletins on the Internet and said 'Ohmygod.' But I let it go at the time.

The worst thing is that it could have been avoided. I just start crying when I think about how my stillborn son and I are victims of an evil drug company. I think money is the most important thing to GlaxoSmithKline. I am both sad and angry. I don't know if I want to ever get pregnant again, it was so traumatic. But one thing I do know is that I will be drug-free. "

In late 2005, the Food and Drug Administration issued a warning after reviewing the results of a study that linked Paxil to birth defects. The FDA determined that exposure to Paxil (generic name: paroxetine) in the first trimester of pregnancy may increase the risk for cardiac malformations. A number of women taking Paxil during the first trimester of pregnancy, compared with women using other antidepressants, reportedly had babies who were born with heart problems.Preliminary data revealed double the rate of birth defects, specifically heart defects, in babies born to mothers who took Paxil in the first three months of pregnancy.