European Medicines Agency and Paroxetine

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Difference between European Medicines Agency and Paroxetine

European Medicines Agency vs. Paroxetine

The European Medicines Agency (EMA) is a European Union agency for the evaluation of medicinal products. Paroxetine, also known by trade names including Paxil and Seroxat among others, is an antidepressant of the selective serotonin reuptake inhibitor (SSRI) class. It is used to treat major depressive disorder, obsessive-compulsive disorder, social anxiety disorder, panic disorder, posttraumatic stress disorder, generalized anxiety disorder and premenstrual dysphoric disorder. It has also been used in the treatment of hot flashes and night sweats associated with menopause. It has a similar tolerability profile to other SSRIs. The common side effects include drowsiness, dry mouth, loss of appetite, sweating, trouble sleeping and delayed ejaculation. It may also be associated with a slightly increased risk of birth defects. The rate of withdrawal symptoms in young people may be higher with paroxetine and venlafaxine than other SSRIs and SNRIs. Several studies have associated paroxetine with suicidal thinking and behavior in children and adolescents. Marketing of the drug began in 1992 by the pharmaceutical company SmithKline Beecham, known since 2000 as GlaxoSmithKline. Generic formulations have been available since 2003 when the patent expired. The United States Department of Justice fined GlaxoSmithKline $3 billion in 2012, including a sum for withholding data on paroxetine, unlawfully promoting it for under-18s and preparing an article, following one of its clinical trials, study 329, that misleadingly reported the drug was effective in treating adolescent depression.

Committee for Medicinal Products for Human Use

The Committee for Medicinal Products for Human Use (CHMP), formerly known as Committee for Proprietary Medicinal Products (CPMP), is the European Medicines Agency's committee responsible for elaborating the agency's opinions on all issues regarding medicinal products for human use.

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European Medicines Agency

The European Medicines Agency (EMA) is a European Union agency for the evaluation of medicinal products.

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European Union

The European Union (EU) is a political and economic union of EUnum member states that are located primarily in Europe.

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Food and Drug Administration

The Food and Drug Administration (FDA or USFDA) is a federal agency of the United States Department of Health and Human Services, one of the United States federal executive departments.

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