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Paxil: Studies
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Exploring the link between Paxil use and suicide, the FDA reports that suicide attempts and suicidal thoughts are three times greater among adolescent Paxil users versus those given a placebo. The risk may be even greater according to a warning issued May 12, 2006 involving a study with Paxil users aged 18 to 30.
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Word is getting out about the risks to an unborn fetus if the mother takes Paxil. The wheels sure grind slowly, though. The initial FDA www.fda.gov warning for women expecting a baby was in September 2005. The FDA based its warning on two studies, the first of which found double the risk of heart defects in babies born to mothers who took Paxil early in their pregnancy, compared to the risk in the general population.
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Partner Steven J. Kherkher manages the Paxil docket for Williams Kherkher Law Firm. Studies have shown that women in the first three months of pregnancies are twice as likely to have a baby with a heart defect if they're taking Paxil during their pregnancies. Steve has been helping sign up Paxil clients since shortly after the FDA issued a health alert in December 2005.
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In July 2006, the FDA issued two alerts related to Paxil. The first FDA alert announced the results of a study concerning the use of antidepressant medicines during pregnancy in mothers of babies born with a serious condition called persistent pulmonary hypertension of the newborn (PPHN). Click here for more information on this FDA alert.
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The announcement was based on the results of three well-controlled clinical trials carried out in children (under 18 years of age) with MDD comparing the effect of Paxil and placebo (sugar pills). The studies found that Paxil did not work any better than placebo in the treatment of MDD. The pediatric studies ... showed that certain, possibly suicide-related behaviors, including suicidal thoughts and attempts, were more common in children receiving Paxil. The risk of these events was about three times greater with Paxil compared with placebo. There were no deaths in these trials.
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