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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.
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.
1 Medical uses
1.2 Panic disorder
1.3 Social anxiety disorder
1.4 Obsessive-compulsive disorder
1.5 Menopausal hot flashes
2 Adverse effects
2.2 Sexual dysfunction
2.4 Discontinuation syndrome
6 Society and culture
6.1 Withdrawal symptoms
6.2 Off-label marketing
6.5 Trade names
9 External links
Paroxetine is primarily used to treat major depressive disorder, obsessive-compulsive disorder, post-traumatic stress disorder, social anxiety disorder, panic disorder, generalized anxiety disorder, premenstrual dysphoric disorder and menopausal hot flashes.
A variety of meta analyses have been conducted to evaluate the efficacy of paroxetine in depression. They have variously concluded that paroxetine is superior or equivalent to placebo and that it is equivalent or inferior to other antidepressants.
Paroxetine was the first antidepressant formally approved in the United States for the treatment of panic disorder.
Social anxiety disorder
Paroxetine has demonstrated efficacy for the treatment of social anxiety disorder in adults and children.
Paroxetine is used in the treatment of obsessive-compulsive disorder.
Menopausal hot flashes
On June 28, 2013, the U.S. Food and Drug Administration approved low-dose paroxetine for the treatment of moderate-to-severe vasomotor symptoms such as hot flashes and night sweats associated with menopause.
See also: List of adverse effects of paroxetine
Paroxetine shares many of the common adverse effects of SSRIs, including (with the corresponding rates seen in people treated with placebo in parentheses): nausea 26% (9%), diarrhea 12% (8%), constipation 14% (9%), dry mouth 18% (12%), somnolence 23% (9%), insomnia 13% (6%), headache 18% (17%), hypomania 1% (0.3%), blurred vision 4%(1%), loss of appetite 6% (2%), nervousness 5% (3%), paraesthesia 4% (2%), dizziness 13% (6%), asthenia (weakness; 15% (6%)), tremor 8% (2%), sweating 11% (2%), and sexual dysfunction (≥10% incidence).
Due to reports of adverse withdrawal reactions upon terminating treatment, the Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency recommends gradually reducing over several weeks or months if the decision to withdraw is made. See also Discontinuation syndrome (withdrawal).
Mania or hypomania may occur in 1% of patients with depression and up to 12% of patients with bipolar disorder.
Like other antidepressants, paroxetine may increase the risk of suicidal thinking and behaviour in children and adolescents.
See also: Selective serotonin reuptake inhibitor § Sexual dysfunction
Sexual dysfunction, including loss of libido, anorgasmia, lack of vaginal lubrication, and erectile dysfunction, is one of the most commonly encountered adverse effects of treatment with paroxetine and other SSRIs. While early clinical trials suggested a relatively low rate of sexual dysfunction, more recent studies in which the investigator actively inquires about sexual problems suggest that the incidence is higher than 70%.
The American College of Obstetricians and Gynecologists recommends that for pregnant women and women planning to become pregnant, “treatment with all SSRIs or selective norepinephrine reuptake inhibitors or both during pregnancy be individualized and paroxetine use among pregnant women or women planning to become pregnant be avoided, if possible”.
See also: SSRI discontinuation syndrome
Many psychoactive medications can cause withdrawal symptoms upon discontinuation from administration. Evidence has shown that paroxetine has among the highest incidence rates and severity of withdrawal syndrome of any medication of its class.
Acute overdosage is often manifested by emesis, lethargy, ataxia, tachycardia, and seizures. Plasma, serum, or blood concentrations of paroxetine may be measured to monitor therapeutic administration, confirm a diagnosis of poisoning in hospitalized patients or to aid in the medicolegal investigation of fatalities. Plasma paroxetine concentrations are generally in a range of 40–400 μg/L in persons receiving daily therapeutic doses and 200–2,000 μg/L in poisoned patients. Postmortem blood levels have ranged from 1–4 mg/L in acute lethal overdose situations.
Interactions with other drugs acting on the serotonin system or impairing the metabolism of serotonin may increase the risk of Serotonin Syndrome or Neuroleptic Malignant Syndrome (NMS)-like reaction. Such reactions have been observed with SNRIs and SSRIs alone, but particularly with concurrent use of triptans, MAO inhibitors, antipsychotics, or other dopamine antagonists.
Paroxetine has been shown to interact with statins, resulting in increased blood glucose levels and potentially diabetes. This was demonstrated in a retrospective study.
The prescribing information states that paroxetine should “not be used in combination with an MAOI (including linezolid, an antibiotic which is a reversible non-selective MAOI), or within 14 days of discontinuing treatment with an MAOI”, and should not be used in combination with pimozide, thioridazine, tryptophan, or warfarin.
Paroxetine interacts with the following cytochrome P450 enzymes:
CYP2D6 for which it is both a substrate and a potent inhibitor.
CYP2B6 ( strong ) inhibitor.
CYP3A4 ( weak ) inhibitor.
CYP1A2 ( weak ) inhibitor.
CYP2C9 ( weak ) inhibitor.
CYP2C19 ( weak ) inhibitor.
Mechanism of paroxetine inhibition of CYP2D6.
Paroxetine is the most potent and one of the most specific selective serotonin (5-hydroxytryptamine, 5-HT) reuptake inhibitors (SSRIs).
K i (nM)
Paroxetine is well-absorbed following oral administration.
Paroxetine is a mechanism-based inhibitor of CYP2D6.
Metabolism of paroxetine in humans.
Society and culture
GlaxoSmithKline has paid substantial fines, paid settlements in class-action lawsuits, and become the subject of several highly critical books about its marketing of paroxetine, in particular the off-label marketing of paroxetine for children, the suppression of negative research results relating to its use in children, and allegations that it failed to warn consumers of substantial withdrawal effects associated with use of the drug.
In 2002 the U.S. FDA published a warning regarding “severe” discontinuation symptoms among those terminating paroxetine treatment, including paraesthesia, bad dreams, and dizziness. The Agency also warned of case reports describing agitation, sweating, and nausea. In connection with a Glaxo spokesperson’s statement that withdrawal reactions occur only in 0.2% of patients and are “mild and short-lived”, the International Federation of Pharmaceutical Manufacturers Associations said GSK had breached two of the Federation’s codes of practice.
Paroxetine prescribing information posted at GlaxoSmithKline now acknowledges the occurrence of a discontinuation syndrome, including serious discontinuation symptoms.
See also: Study 329
In early 2004, GSK agreed to settle charges of consumer fraud for $2.5 million.
In 2012 the U.S. Justice Department announced that GSK agreed to plead guilty and pay a $3 billion fine, in part for promoting the use of Paxil for children.
On 12 February 2016, the UK Competition and Markets Authority imposed record fines of £45 million on companies which were found to have infringed European Union and UK Competition law by entering into agreements to delay the market entry of generic versions of the drug in the UK. GlaxoSmithKline received the bulk of the fines, being fined £37,600,757. Other companies, which produce generics, were issued fines which collectively total £7,384,146. UK public health services are likely to claim damages for being overcharged in the period where the generic versions of the drug were illegally blocked from the market, as the generics are over 70% less expensive. GlaxoSmithKline may also face actions from other generics manufacturers who incurred loss as a result of the anticompetitive conduct.
In 2007, paroxetine was ranked 94th on the list of bestselling drugs, with over $1 billion in sales. In 2006, paroxetine was the fifth-most prescribed antidepressant in the U.S. retail market, with more than 19.7 million prescriptions.
Trade names include Aropax, Brisdelle, Deroxat, Paxil, Sereupin, and Seroxat.
Several studies have suggested that paroxetine can be used in the treatment of premature ejaculation. In particular, intravaginal ejaculation latency time (IELT) was found to increase with 6–13-fold, which was somewhat longer than the delay achieved by the treatment with other SSRIs (fluvoxamine, fluoxetine, sertraline, and citalopram).
There is also evidence that paroxetine may be effective in the treatment of compulsive gambling
Benefits of paroxetine prescription for diabetic neuropathy are uncertain.
Although the evidence is conflicting, paroxetine may be effective for the treatment of dysthymia, a chronic disorder involving depressive symptoms for most days of the year.
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