Zantac Lawsuit


Researching drug company and regulatory malfeasance for over 16 years
Humanist, humorist

Friday, August 17, 2007

Paxil Is A Direct Link To Birth Defects

By J Mundy


When 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.

FULL HEART WRENCHING STORY CAN BE READ HERE

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