Story Highlights• A mom fears the Paxil she took while pregnant caused her son's heart defect
• FDA says two studies suggest paroxetine, or Paxil, increases birth defect risk
• Paxil's labeling was changed last year to warn about the risks of birth defects
By Jennifer Pifer
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BEDFORD, Texas -- One of the first things you notice about Adrian Vasquez is the bulge beneath his shirt. It's a pacemaker, the size of a chocolate-covered Oreo cookie.
Adrian is only 2 1/2 years old.
Born with a double outlet on the right ventricle of his heart, Adrian has endured three open-heart surgeries and countless trips to the emergency room.
His life has been fragile from the beginning. The day after Adrian was born, a hospital chaplain baptized him in the ICU. With a tube in his nose helping him breathe, Adrian's mother and father sprinkled holy water on his tiny head. He was so weak, they weren't allowed to hold him. Adrian's first surgery was three days later, when he was 5 days old. (Watch a boy with a broken heart )
Sitting in their home in suburban Dallas, Texas, Anthony and Matilda Vasquez recently talked about the night their son almost died. Adrian was 5 months old and had just undergone surgery. He had been in the hospital for about a week and seemed to be thriving. In the middle of the night, the young couple got a call.
Adrian was crashing.
They rushed to the hospital. Anthony Vasquez says Adrian was "gasping for air and turning blue." It took doctors a half-hour to stabilize him. "He pulled out of it," Vasquez says with fatherly pride.
For a long time, Matilda Vasquez says, she went over in her head every aspect of her pregnancy, trying to figure out whether she did something to cause Adrian's heart problems. She says she didn't smoke, didn't drink, exercised and watched her diet. She says she didn't even want to take aspirin for fear it would hurt the baby. However, she was taking the antidepressant Paxil when she got pregnant. She says she asked her doctor about it and after checking the labeling, he said it was safe for her to keep taking it.
But late last year, Anthony Vasquez heard something on television about Paxil, heart problems and babies. He checked the Internet and found a warning from the Food and Drug Administration. It said early results from two studies suggested women who took Paxil during the first three months of pregnancy were 1.5 to 2 times as likely to have a baby born with a heart defect as women who received other antidepressants or women who didn't take antidepressants.
Paxil is made by Glaxo Smith-Kline. A company internal study released in 2005 and shared with the FDA found a 1.5 times increased risk for heart malformations for Paxil compared with other antidepressants. Normally, the risk of giving birth to a child with a heart defect is about 1 percent.
At the urging of the FDA, Glaxo Smith-Kline changed Paxil's labeling in September 2005 to warn about the risks of birth defects.
Adrian's parents were furious. They believe Glaxo Smith-Kline was aware of the drug's risk before he was born in April 2004 and didn't do enough to warn doctors or expectant mothers. In July, the family sued the company. Glaxo Smith Kline declined to comment on the lawsuit, but in a written statement said it has diligently monitored the safety of Paxil before and after its approval by the FDA in 1992.
The American Medical Association estimates about 40,000 women take antidepressants while pregnant. Weaning a woman off an antidepressant while pregnant can be excruciating. Many doctors we spoke with say the pros often outweigh the cons.
On Wednesday, the American College of Obstetrics and Gynecologists Committee on Obstetric Practice recommended that the use of paroxetine, or Paxil, among pregnant women or women planning to become pregnant be avoided, if possible. The group also said that treatment with with all SSRIs or selective norepinephrine reuptake inhibitors or both during pregnancy be judged on a case by case basis.
But Matilda Vasquez believes expectant mothers should have all the information so they can make the decision for themselves. She says had she known about the possibility of heart defects, she would have stopped taking Paxil.
These days, Adrian spends a lot of time at the doctor's office. He is behind developmentally and communicates on the level of a 9-month-old. His big brother, Isaiah, often "translates" for his parents and grandparents. It breaks his father's heart to think that Adrian will never be able to do "boy things" like roughhousing or playing soccer.
When it's not too hot, Adrian and his brother "drive" around the family's back yard in a child-sized electric truck. The boys smile and squeal as their dad follows. Matilda Vasquez smiles at her family, but there is also a longing in her eyes. "Adrian will never have a normal life," she says. "I just hope this lawsuit will just warn people and let them see what an innocent baby can go through."
Jennifer Pifer is a senior producer with CNN Medical News.
Adrian Vasquez, who's 2 1/2, has had three open-heart surgeries and now has a pacemaker.
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