Paroxetine or paroxetine hydrochloride (sold as Paxil in the United States and Canada; Seroxat in Austria, the UK and China; Aropax in Australia, New Zealand and Brazil; Pondera in Brazil; Deroxat in Switzerland and France, and Cebrilin in Latin America) is a selective serotonin reuptake inhibitor (SSRI) antidepressant. It was released in 1992 by the pharmaceutical company GlaxoSmithKline and has since become one of the most prescribed antidepressants on the market. It is the second most prescribed anti-depressant in the UK. It is now the subject of a fraud case in the United States due to allegations that GlaxoSmithKline suppressed research indicating that the drug caused young people to become suicidal.
Like some other antidepressants, it is also prescribed in the treatment of anxiety disorders and obsessive-compulsive disorder (OCD). It was the first (and as of 2002, the only) antidepressant formally approved in the United States for the treatment of social anxiety disorder, causing it to be sometimes referred to (although inaccurately) as an anti-shyness drug.
Paroxetine is a potent and selective serotonin (5-hydroxytryptamine, 5-HT) reuptake inhibitor (SSRI). This activity of the drug on brain neurons is thought to be responsible for its antidepressant effects.
Paroxetine is a phenylpiperidine derivative which is chemically unrelated to the tricyclic or tetracyclic antidepressants. In receptor binding studies, paroxetine did not exhibit significant affinity for the adrenergic (alpha(1), alpha(2), beta), dopaminergic, serotonergic (5HT(1), 5HT(2)), or histaminergic receptors of rat brain membrane. A weak affinity for the muscarinic acetylcholine and noradrenaline receptor was evident. The predominant metabolites of paroxetine are essentially inactive as 5-HT reuptake inhibitors.
Paroxetine is chemically identified as (Immediate-Release Tablets / Oral Suspension:) (-)-trans-4R-(4-fluorophenyl)-3S-piperidine hydrochloride hemihydrate, or (Controlled-Release Tablets:) (-)-(3S,4R)-4-methyl] piperidine hydrochloride hemihydrate. Its empirical formula is C19H20FNO3, with a molecular weight of 374.8 (329.3703 as free base).
Paroxetine hydrochloride is an odorless, off-white powder, having a melting point range of 120 to 138C and a solubility of 5.4 mg/mL in water.
Concerns are growing about the side effects of Paxil.
Recent studies have found that the drug is relatively ineffective in children, and suggested that they are prone to becoming suicidal in the early stages of treatment. Some psychologists believe that this is due to the way the drug begins to work in many patients. The first effect most people notice is a decrease in the lethargy and amotivation they experienced during their depression. This effect happens before the depression itself improves, so children may end up with enough "energy" and motivation to act on suicidal tendencies they may have already had.
It is also important to note many people who are prescribed Paxil are suicidal to begin with. However most studies have compared suicide rates in patients using Paroxetine against a control group of depressed individuals not being treated with paroxetine and the paroxetine group was reported to be twice as likely to commit suicide.
Although the manufacturers say there is no reliable clinical evidence that the drug can cause violence or aggression, a wrongful death suit was filed against GlaxoSmithKline in June 2001 by the surviving family of Donald Schell, a Wyoming man who had killed his wife, daughter and grandchild after two days on the drug. During the investigation of the clinical records, it was reported that, although paroxetine is safe and effective most of the time, in a minority of cases the drug can cause unpredictable side effects such as wild mood swings or suicidal thoughts. The jury ultimately awarded damages of $8 million against GlaxoSmithKline.
In June 2004, New York attorney general Eliot Spitzer began civil proceedings against GlaxoSmithKline over allegations that the company had suppressed five internal studies between 1998 and 2002 on the effects of the drug on both children and adults. The studies suggested that, in children, the drug had effects ranging from that of a placebo to inducing suicidal tendencies in its users. The company responded shortly later by making the results of the studies publicly available.
In March 2005, the United States Food and Drug Administration ordered the seizure of millions of tablets of Paxil after 3 years of GlaxoSmithKline's unresolved manufacturing problems. These problems involved Paxil CR, a time-release version of the drug. Some capsules were found to break in two, potentially resulting in the user taking only the active element of the drug without the time-release portion, or vice versa.
In September 2005 the Therapeutic Goods Administration (TGA) of Australia issued a warning about the potential for increased birth defects in the babies of pregnant women taking the anti-depressant Paroxetine. Early results from pharmaceutical giant GlaxoSmithKline suggest an association between taking the drug in the first three months of pregnancy and birth defects. The risk of cardiovascular defects may double from 1 to 2 percent in babies of women taking Paroxetine. A recent Dutch study suggests a 60 per cent increase in defects. The TGA is urging women not to suddenly stop taking the SSRI as withdrawal may cause harmful side effects. In December 2005, the United States Food and Drug Administration issued a similar public health advisory . In this report, the FDA has decided to change paroxetine from pregnancy category C to D, indicating a higher degree of caution is warranted when using paroxetine in pregnant women.
Common side effects include:
Decreased or eliminated sexual desire
Delayed or eliminated orgasm
Restlessness or akathisia
Changes in urination
Changes in appetite
Individuals experiencing any of the following symptoms should contact their doctor immediately:
Jaw, neck, and back muscle spasms
Fever, chills, sore throat, or flu-like symptoms
Yellowing of the skin or eyes
Black, tarry stools (this can indicate upper GI bleeding)
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