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Thursday, October 15, 2009

Philadelphia Jury Find GlaxoSmithKline Guilty In Paxil-Birth Defects Lawsuit

Philadelphia jury has found GlaxoSmithKline guilty of negligence, but not guilty of outrageous conduct. It Awarded 2.5 million. The verdict is the first of about 600 similar Paxil lawsuits filed across the United States according to the Associated Press
Drug maker GlaxoSmithKline plans to appeal a $2.5 million verdict in a lawsuit that alleged the company's antidepressant drug Paxil caused birth defects.
This lawsuit was launched by a Philadelphia family whose son was born four years ago with a number of heart defects.
In 2005, the U.S. Food and Drug Administration (FDA) issued warnings that Paxil may be associated with birth defects, the AP reported.
The first study illustrates the potential risk of relapsed depression after stopping antidepressant medication during pregnancy. The authors followed pregnant women who in the past had major depression. During their pregnancy, some of these women were not feeling depressed and stopped taking their antidepressant medicines. Others stayed on their antidepressant medicines while pregnant. The women who stopped their medicine were five times more likely to have a relapse of depression during their pregnancy than were the women who continued to take their antidepressant medicine while pregnant. This study, by Lee Cohen and other authors, was published February 1, 2006 in the Journal of the American Medical Association (JAMA).

A second study suggests there may be additional, though rare, risks of SSRI medications during pregnancy. This study focused on newborn babies with persistent pulmonary hypertension (PPHN), which is a serious and life-threatening lung condition that occurs soon after birth of the newborn. Babies with PPHN have high pressure in their lung blood vessels and are not able to get enough oxygen into their bloodstream. About 1 to 2 babies per 1000 babies born in the U.S. develop PPHN shortly after birth, and often they need intensive medical care. In this study PPHN was six times more common in babies whose mothers took an SSRI antidepressant after the 20th week of the pregnancy compared to babies whose mothers did not take an antidepressant. The study was too small to compare the risk in one drug compared to another, and this risk has not so far been investigated by other researchers. The study, by Christina Chambers and others, was published on February 9, 2006 in The New England Journal of Medicine.

1 comment:

Bill Hawthorne said...


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Barbara O’ Brien


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