The first warning Faith Gibson had that the hole in her 3 ½-year-old daughter’s heart was caused by the anti-anxiety drug that she thought was safe to take during pregnancy, was when she read a newspaper story about another little girl born with the same birth defect. That mother was suing drug maker GlaxoSmithKline (GSK) for failing to warn her of the risk of heart defects in newborns when taking Paxil during pregnancy. It was the same medication Gibson had taking since 2002 and during her pregnancy.
What Gibson soon realized was that a warning about heart defects in infants born to women who took Paxil during pregnancy was issued the very month her daughter was born.
“I never would have taken the (Paxil) had I been told,” Gibson told a reporter for The Province.
The long, red scar down the middle of her daughter’s chest is a painful reminder of the condition she was unnecessarily born with. She says her daughter’s heart defect has made the little girl prone to infections and stunted her growth.
In 2005, the FDA issued a warning to pregnant women and their doctors to stay away from Paxil because of the increased risk of heart defects in newborns. The agency fell short of banning the medication for pregnant women but stated that it “is advising patients that this drug should usually not be taken during pregnancy.”
The risk of heart defects among newborns is about 1 percent overall. For infants born to women taking Paxil, that number jumps to 1.5 to 2 percent, according to studies cited by the FDA.