Beasley, Allen, Crow, Methvin, Portis & Miles, P.C.

Clinical trials testing experimental and currently marketed pharmaceutical drugs help determine the medication’s safety and efficacy. This information is vital to policy makers and doctors, who generally read about these studies in peer-reviewed medical journals. But only a fraction of data from these clinical trails is ever published, a travesty that both “distorts scientific record” and puts patients lives at risk, the British Medical Journal warns.

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When Lyam Kilker was born October 2005, he was diagnosed with three separate heart defects – an atrial septal defect, a ventricular septal defect, and an interrupted aortic arch. What his mother didn’t realize at the time is that Paxil, the medication she was given for depression while she was pregnant, likely caused her son’s serious heart conditions.

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It has been nearly six years since the Food and Drug Administration (FDA) first warned consumers that studies linked the antidepressant Paxil (paroxetine) with an increased risk of birth defects, particularly heart defects, when women take it during the first three months of pregnancy. Since then, additional studies have reinforced the need to warn users of these potential consequences.

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Manie’s parents want answers. Their beautiful son was born with transposition of the greater arteries and endured surgeries children should never have to experience. His parents blame GlaxoSmithKline (GSK), makers of the antidepressant Paxil.

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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.

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The parents of a two-year old boy have filed a lawsuit against the maker of Paxil, alleging that the mother’s use of the antidepressant during pregnancy cause her son to be born with severe heart defects.

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The Food and Drug Administration today is alerting health care professionals and patients about early results of new studies for Paxil (paroxetine) suggesting that the drug increases the risk for birth defects, particularly heart defects, when women take it during the first three months of pregnancy.  Paxil is approved for the treatment of depression and several other psychiatric disorders.  FDA is currently gathering additional data and waiting for the final results of the recent studies in order to better understand the higher risk for birth defects that has been seen with Paxil. 

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The Food and Drug Administration said Thursday that the warning label on GlaxoSmithKline’s widely-prescribed anxiety drug Paxil has again been revised to advise the drug may cause heart defects in babies.

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Preliminary study data suggest that the antidepressant paroxetine should not be prescribed to pregnant women.

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