Legal Law

Paxil is a direct link to birth defects

When Bonnie was concerned about staying on Paxil, she was told not to worry as she was classified as Category B. Tragically, her son died of congenital heart defects; five years later, he discovered that Paxil is now Category D.

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

“I started taking Paxil when I was in high school,” says Bonnie (not her real name pending a lawsuit). Then I stopped taking it when I got pregnant with my oldest son: I have four children. But when 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 away from family and friends and I started taking Paxil again. I called my mom (she is a nurse) and asked if there were any risks in taking this medicine. He looked it up in the drug book and it was a category B, so there were no warnings or side effects; this would have been at the end of 2001.

My husband lost his job again and we moved further afield, so I stayed at Paxil. I gave birth to Keagan and when he was only six hours old, the doctor told me that he had to be transferred to the 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. You were diagnosed with critical aortic stenosis – your aortic valve was not working properly. He was also diagnosed with Hypoplastic Left Heart Syndrome (HLHS), one of the rarest heart defects, which means that the left ventricle is working poorly or could be non-existent. He also had endocardial fibroelastosis (EFE).

It was heartbreaking, everything I went through to get pregnant with him and then to be told he had serious heart defects … We had a family on a plane from Canada, from Oregon and Washington. My sister took my children to Washington with her. I slept in the hospital almost every night and much of my family stayed across the street, in a place like a Ronald Macdonald charity house.

At three weeks of age, Keagan suffered from aortic valve swelling; he was scheduled for open heart surgery and another emergency surgery the next day. When I arrived at the hospital on the morning of February 7, he had written in his chart that the family should spend time with him and hug him as much as possible. Until that moment I had not been allowed to hug him.

I called my husband to return 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 hugged 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 established and called members of our church; they had been very supportive. My minister, his wife, and other members of the congregation came. Things were not getting better. Keagan’s white blood cell count got very high and he was bleeding from one of his lungs. The doctor met with me, my husband and our minister and asked us if we wanted to let him go or continue with the treatment.

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

We had a little service for our son and my church was wonderful – they paid for Keagan’s service and cremation. We gave the hospital permission to perform an autopsy on his heart and lung, and my husband and I agreed to genetic testing. At this point he had no idea that there was a connection to Paxil. After the autopsy results came in, they told us it was something that had just happened; there was no explanation.

Last week I saw a commercial on television for a law firm that said there was a possible link between Paxil and congenital heart defects. I called my mom right away and she looked it up again in her drug book, this time it was a category D risk. Later that night my sister looked up Paxil on the internet and said there was a lot of information about the link between Paxil and coronary heart defects. He found your website for me and the next day a lawyer contacted me.

I hardly continue with this lawsuit because I had come to terms with Keagan’s death and now everything is new again. But I don’t want other parents to have to go through what I went through.

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