Paxil: A Fatal Link to Coronary Birth Defects

Todd, NCWhen Bonnie was concerned about staying on Paxil she was told not to worry as it was classified as Category B. Tragically, her son died from heart birth defects; five years later she discovered that Paxil is now Category D.

(In December 2005, the FDA asked Glaxo Smith Kline, the manufacturer of Paxil, to change the pregnancy category to D, a stronger warning. Category D means that studies in pregnant women have demonstrated a risk to the fetus.)

"I first started taking Paxil when I was in high school," says Bonnie (not her real name pending a lawsuit). Then I quit taking it when I got pregnant with my oldest child - I have four kids. But by the time I was pregnant with Keagan, my life had become difficult and I was very depressed; my husband's job meant that we had to move far away from family and friends and I started taking Paxil again. I called my Mum (she is a nurse) and asked her if there was any risk in taking this drug. She looked it up in the drug book and it was a category B so there were no warnings and no side effects - this would have been late in 2001.

My husband lost his job again and we moved even farther away, so I stayed on Paxil. I gave birth to Keagan and when he was only six hours old the doctor told me that he had to be transported to Children's Hospital because his oxygen saturation was low and they had detected a heart murmur.

As soon as he was transferred, Keagan underwent his first heart surgery. He was diagnosed with critical aortic stenosis - his aortic valve wasn't functioning properly. They also diagnosed him with hypoplastic left heart syndrome (HLHS) - one of the rarer heart defects which means that the left ventricle is under-functioning or it could be non-existent. He also had endocardial fibroelastosis (EFE).

It was heartbreaking - everything I went through to stay pregnant with him and then to be told that he had severe heart defects... We had family fly in from Canada, from Oregon and Washington. My sister took my kids back to Washington with her. I slept in the hospital almost every night and a lot of my family stayed across the street, in a place like a Ronald Macdonald Charity house.

At three weeks old, Keagan had a ballooning of his aortic valve; he had one scheduled open heart surgery and another emergency surgery the following day. When I got to the hospital the morning of Feb 7th it had been written in his chart that family was to spend time with him and hold him as much as possible. Up to that point I hadn't been allowed to hold him.

I called my husband to come back to the hospital immediately and then it took two nurses and the respiratory therapist to move Keagan from his little bed into my arms. Between me and my family, we held him all day. Then he started having problems with blood and oxygen levels so the doctors asked if we wanted to have a 'Do Not Resuscitate' (DNR) order.

We opted for the DNR to be put in place and called members of our church; they had been so supportive. My minister, his wife and other members from the congregation came. Things weren't improving. Keagan's white blood cell count went really high and he was bleeding in one of his lungs. The doctor met with me and my husband and our minister and asked if we wanted to let him go or pursue treatment.

At that point we decided to let him go. At 10 pm, with Keagan in my arms, our minister sat in the room and prayed for about 10 minutes, then my husband and I were left alone with our son. The nurse stopped everything except for pain medication and the doctor disconnected the respirator. At 11pm his heart stopped beating.

We had a small service for our son and my church was wonderful - they paid for the service and Keagan's cremation. We granted the hospital permission to autopsy his heart and lung and my husband and I consented to genetic testing. At this time I had no idea there was a connection to Paxil. After his autopsy results came back, we were told it was a thing that just happened; there was no explanation.

Last week I saw a commercial on television from a law firm, saying there was a possible link between Paxil and heart birth defects. I called my Mum right away and she looked it up again in her drug book - this time it was a category risk D. Later that evening my sister looked up Paxil on the Internet and she said there was a lot of information about the link between Paxil and coronary heart defects. She found your website for me, and the following day a lawyer contacted me.

I almost didn't go through with this lawsuit because I had come to terms with Keagan's death and now it is all fresh again. But I don't want other parents to have to go through what I went through."