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Paxil: Us Fda
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Paxil is the brand name. Paroxetine is the generic name. Paxil is a selective serotonin reuptake inhibitor (SSRI) used to treat depression and other disorders.SSRI medications affect levels of serotonin in the brain. For many people, these medications are the first choice for the treatment of depression. For information on SSRIs and how they work, see SSRIs and Depression.
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Paxil is an anti-depressant that was approved in the US in 1992. As the figures of depression sufferers began to increase sales of Paxil and similar drugs ... soared. However, it has been claimed that Paxil can cause severe dependency and can result in life-threatening withdrawal symptoms. In 2003 the Food and Drugs Administration issues a warning about the effects of Paxil, which sparked fresh controversy on an already controversial drug.
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Paxil® has other serious side effects besides increasing the risk of birth defects. Children and teenagers who take Paxil® may become more depressed, according to some studies. The FDA states that one out of every 50 children or adolescents who take antidepressants such as Paxil® may think about suicide, talk about it, or go through with the act (Patient Information Sheet, July 8, 2005).
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In spite of the apparent health risks among children, the manufacturer of Paxil nonetheless has requested FDA approval that would allow doctors to prescribe Paxil to children and adolescents. That application currently is pending, although influential policymakers have expressed concerns over the application.
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Paxil is as effective in relieving depression as TCAs such as imipramine. However, Paxil causes fewer adverse cardiovascular and anticholinergic effects (dry mouth, constipation, blurred vision, urinary retention) than the older TCAs. It does not usually cause drowsiness, low blood pressure, or weight changes. Paxil has no active metabolites and leaves one's system 24 hours after it enters. SmithKline Beecham Pharmaceuticals, which makes Paxil, states that Paxil is the most selective of the SSRI antidepressants. This selectivity causes serotonin levels in the brain to normalize quickly, relieving depression with relatively few side effects.
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In 2003, Glaxo sponsored a study that indicated that use of Paxil during pregnancy increased the risk of Paxil birth defects more than 2-fold, with the most common defect being cardiovascular abnormalities. However, through 2005, Glaxo marketed the leading anti-depressant, Paxil as a Pregnancy Category C drug. The FDA Pharmaceutical Pregnancy Categories indicate the potential for fetal risk caused by exposure to medications during pregnancy. This rating indicates that animal studies have shown adverse effects on the fetus but that there are no adequate well-controlled studies in humans.
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