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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About $1 billion has been paid out by drug maker GlaxoSmithKline to resolve “failure to warn” lawsuits over its popular antidepressant Paxil. The lawsuits include cases of birth defects, suicides, and addiction allegedly caused by the medication.

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GlaxoSmithKline has awarded millions of dollars in compensation to women who took the antidepressant Paxil (paroxetine) while pregnant and delivered babies with serious birth defects.

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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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In 2005, GlaxoSmithKline informed health care professionals that it was updating the Pregnancy subsection of the PRECAUTIONS section of the labels for its popular antidepressant medication Paxil to indicate the risk of possible side effects based on a study conducted by the drug maker. The study revealed a greater risk of birth defects in infants born to woman taking antidepressants during the first trimester. An even greater risk was found associated with the use of Paxil over other antidepressants in the study.

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Women who experience symptoms of depression prior to becoming pregnant have an increased risk of preterm birth, but black women who are depressed are at greater risk of delivering a preterm baby than white women, according to a report in the Journal of Women’s Health.

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Pregnant women and new mothers who have diabetes are nearly twice as likely to suffer from symptoms of postpartum depression compared to pregnant women and new mothers who do not have diabetes, according to a Harvard Medical School and University of Minnesota School of Public Health study.

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Emory University has reprimanded one of its leading psychiatrists for speaking on behalf of a drug company while conducting research that touched on the use of that company’s drug in pregnant women.

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