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The ftc is investigating glaxosmithkline s tactics to protect its antidepressant, paxil.

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Antidepressant medications are used to treat a variety of conditionsincluding depression and other mental/mood disordersThese medications can help prevent suicidal thoughts/attempts and provide other important benefitsHoweverstudies have shown that a small number of peopleespecially people younger than 25who take antidepressants for any condition may experience worsening depressionother mental/mood symptomsor suicidal thoughts/attemptsThereforeit is very important to talk with the doctor about the risks and benefits of antidepressant medicationespecially for people younger than 25even if treatment is not for a mental/mood condition.

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In a placebo-controlled study in elderly patients with major depressive disorderthe most common side effects associated with treatment discontinuation of controlled-release paroxetine included nauseaheadachedepressionand abnormal LFTs.

In placebo-controlled clinical trials patients receiving paroxetine experienced abnormal values on liver function tests at a rate equal to or less than that reported in patients receiving placeboHoweverthere have been postmarketing reports of patients developing elevated serum transaminases resulting in severe liver dysfunctionas well asa few cases of elevated liver function tests resulting in death secondary to liver necrosisRef]

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the skb representative told the committee they examined the data on the phase ii placebo group and that few numbers of patients experienced any adverse event after being randomized off paxil into the placebo group and the percentages are certainly very small.

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