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New data linking paroxetine use during the first trimester of pregnancy with increased risk of major congenital malformations has prompted changes to the drug’s label. Preliminary results of a retrospective epidemiologic study sponsored by GlaxoSmithKline Inc., the drug’s maker, show paroxetine (marketed as Paxil), was associated with more congenital malformations (adjusted odds ratio 2.20) and more cardiovascular malformations (adjusted odds ratio 2. 
than other antidepressants in almost 3,600 pregnant women.
GLAXOSMITHKLINE has been forced to drop US adverts for its biggest- selling drug, the anti-depressant Paxil, after a court in Florida ruled they could be misleading.
GSK said it would appeal against the judgment, which bans its adverts for the duration of a trial in which a group of users claim it is addictive.
The court ruled the adverts were creating inaccurate expectations about the ease of withdrawal from the drug, after the “plaintiffs have demonstrated that, at least for some patients, there is more than a mere possibility that severe reactions can accompany a withdrawal from Paxil“.
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