Paxil (paroxetine) is an antidepressant medication. It is used to treat anxiety disorders, depression, and hot flashes. It has not been approved for use in children and older adults are more likely to develop serious complications from taking it. Pregnant and breastfeeding women should only take this drug if the benefit exceeds the risk to their newborn.
In March 2005, US marshals seized lots of Paxil CR from GlaxoSmithKline due to subpar manufacturing standards resulting in poor quality pharmaceutical products. It was discovered that Paxil CR tablets were breaking and were not delivering the correct amount of medication at the correct rate. (fda.gov)
Questions & Answers
Side Effects & Adverse Reactions
People taking this drug have reported mood and behavior changes including panic attacks, aggression, hyperactivity, and suicidal thoughts and behaviors. It can alter the way you think and behave, so be aware of how it affects you before you do anything that is potentially dangerous (like driving).
Methylene blue injection, pimozide, and thioridazine should not be taken with paroxetine. Using a Monoamine oxidase inhibitor (MAOI) within 14 days of starting or stopping this drug is very dangerous. Other common MAOIs are Selegiline, Phenelzine, and Tranylcypromine. Taking Paxil with NSAIDS (non steroidal anti-inflammatory drugs) and other drugs that thin blood can cause individuals to bruise and bleed more than usual. Other medications that cause drowsiness such as muscle relaxants and narcotic pain killers will intensify this effect. Consuming alcohol can increase side effects and is not recommended. This drug can change the way certain medications in your bloodstream work including Coumadin (warfarin) and antipsychotics such as Abilify (aripiprazole) and Risperdal (risperidone).
Paroxetine can cause serious side effects including facial swelling, agitation, trouble sleeping, blurry vision, bone fractures, muscle stiffness, and rash. It can also cause changes in sexual function, trouble breathing, hallucinations, irregular heartbeat, and seizures. You should be cautious when taking it if ulcers, bleeding problems, seizures, liver, or kidney issues run in your family. Older adults taking it are more likely to develop side effects including hyponatremia- a disorder characterized by low blood sodium. Men that plan to have children should use this drug with caution because it can lower sperm count. Paroxetine has not been approved for pediatric use because the effects on children are not well-researched. (webmd.com)
Clinical Worsening and Suicide Risk
Patients with major depressive disorder (MDD), both adult and pediatric, may experience worsening of their depression and/or the emergence of suicidal ideation and behavior (suicidality) or unusual changes in behavior, whether or not they are taking antidepressant medications, and this risk may persist until significant remission occurs. Suicide is a known risk of depression and certain other psychiatric disorders, and these disorders themselves are the strongest predictors of suicide. There has been a long-standing concern, however, that antidepressants may have a role in inducing worsening of depression and the emergence of suicidality in certain patients during the early phases of treatment. Pooled analyses of short-term placebo-controlled trials of antidepressant drugs (SSRIs and others) showed that these drugs increase the risk of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults (ages 18-24) with major depressive disorder (MDD) and other psychiatric disorders. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction with antidepressants compared to placebo in adults aged 65 and older. It is unknown whether the suicidality risk extends to longer-term use, i.e., beyond several months. However, there is substantial evidence from placebo-controlled maintenance trials in adults with depression that the use of antidepressants can delay the recurrence of depression.
|Age Range||Drug-Placebo Difference in Number of Cases of Suicidality per 1,000 Patients Treated|
|Increases Compared to Placebo|
|<18||14 additional cases|
|18-24||5 additional cases|
|Decreases Compared to Placebo|
|25-64||1 fewer case|
|≥65||6 fewer cases|
Serotonin Syndrome or Neuroleptic Malignant Syndrome (NMS)-like Reactions
This medication has one of the highest rates of withdrawal symptoms among those who stop taking it. SSRIs should never be discontinued abruptly; your dose should be gradually reduced by a doctor. Serotonin syndrome or Neuroleptic Malignant Syndrome (NMS)-like reactions have been reported with SNRIs and SSRIs alone, including treatment with PAXIL, but particularly with concomitant use of serotonergic drugs (including triptans) with drugs which impair metabolism of serotonin (including MAOIs), or with antipsychotics or other dopamine antagonists. Serotonin syndrome symptoms may include mental status changes (e.g., agitation, hallucinations, coma), autonomic instability (e.g., tachycardia, labile blood pressure, hyperthermia), neuromuscular aberrations (e.g., hyperreflexia, incoordination) and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea). Serotonin syndrome, in its most severe form can resemble neuroleptic malignant syndrome, which includes hyperthermia, muscle rigidity, autonomic instability with possible rapid fluctuation of vital signs, and mental status changes. Patients should be monitored for the emergence of serotonin syndrome or NMS-like signs and symptoms. (aafp.org)
Use During Pregnancy
Paxil is labeled as a Category D pregnancy risk and should only be administered to pregnant and nursing women if the benefit to the mother outweighs the risk to the infant. Epidemiological studies have shown that infants exposed in the first trimester of pregnancy have an increased risk of congenital malformations, particularly cardiovascular malformations.
Several class-action lawsuits have been filed against GlaxoSmithKline, the makers of Paxil, as a result of failing to sufficiently warn consumers of its addictive properties. The same company paid $2.5 million to settle charges of consumer fraud in 2004 for knowingly and systematically withholding unfavorable research findings from consumers. In 2012, they were penalized $3 billion - the largest fine in US healthcare fraud history - resulting from various civil and criminal charges including off-label marketing to treat children.
FDA Safety Alerts
In December 2005, the FDA announced that PAXIL (paroxetine HCl) and PAXIL CR (paroxetine HCl) Controlled-Release Tablets can cause major congenital malformations in infants born to mothers that took the drug during their first trimester of pregnancy. They increased the pregnancy risk category from “C” to “D” - acknowledging the risks of use and the danger to the fetus. (fda.gov)
The FDA issued a public health advisory in May 2014 to alert consumers and healthcare providers of worsening depression in patients with major depressive disorder that take Paxil and other antidepressants. These individuals are at an increased risk of suicidal thoughts and behaviors, especially when starting it or following an increase in dose. Other antidepressants that increase these risks are Zoloft (sertraline), Lexapro (escitalopram), Effexor (venlafaxine), Prozac (fluoxetine), Wellbutrin (bupropion), Remeron (mirtazapine), Luvox (fluvoxamine), Serzone (nefazodone), and Celexa (citalopram). (fda.gov)
There are currently no manufacturer warnings for Paxil.
FDA Labeling Changes
July 2014 - Paxil and other drugs used to treat major depressive disorder cause pupillary dilation and may cause an angle closure attack in people with narrow angles who don’t have a patent iridotomy (a treatment for block glaucoma). Taking paroxetine can result in eye pain, eye swelling or redness, and changes in vision. (fda.gov)
December 2012 - Paxil causes Stevens-Johnson Syndrome, a disease of the skin and mucous membranes with flu-like symptoms, painful rash, and blisters. This is a medical emergency that typically requires hospitalization, and it can take months after discontinuing use to recover. (fda.gov)
July 2011 - Patients on a reversible MAOI such as methylene blue or linezolid should not take Paxil, Paxil CR Tablets, or Paxil Oral Suspension due to the increased risk of developing serotonin syndrome, a condition caused by dangerously high levels of the chemical in the brain. Symptoms of serotonin syndrome are diarrhea, fever, shivering, seizures, and stiff muscles and can be fatal if not treated. Individuals taking reversible MAOIs are also at risk for neuroleptic malignant syndrome (NMS), a disorder that also causes stiff muscles and fever, in addition to other symptoms including hypothermia and changes in consciousness. Patients taking pimozide should not take paroxetine. (fda.gov)
March 2011 - The efficacy of tamoxifen (a medication that treats breast cancer) is reduced when taken with Paxil. (fda.gov)
October 2010 - SSRI’s and other antidepressants can result in an increased risk of developing bone fractures and can cause swelling, bruising, and point tenderness (pain felt in response to pressure on a particular area of the body). Paroxetine can also cause restless leg syndrome and infertility in men. (fda.gov)
October 2008 - Drugs metabolized by CYP2D6 (a liver enzyme) such as fluoxetine, risperidone, amitriptyline, type 1C antiarrhythmics (flecainide, propafenone, and encainide), and medications that inhibit this enzyme (including quinidine) may become less effective when taken with Paxil. (fda.gov)
Paroxetine is an antidepressant medication in the selective serotonin reuptake inhibitor (SSRI) class of drugs. It balances the neurotransmitter serotonin - a chemical in the brain that is believed to affect mood, appetite, energy level, and sleep. It is prescribed to patients suffering from depression, anxiety disorders, premenstrual dysphoric disorder, posttraumatic stress disorder (PTSD), and obsessive-compulsiveness disorder (OCD). This drug is sold in the United States under the brand names Paxil, Paxil CR, Brisdelle, and Pexeva. Other trade names are Aropax (in New Zealand), Deroxat (in France), Sereupin (a derivative that is available worldwide), Paxtine (in Australia), and Paraxyl (in Pakistan). It comes in two forms: tablet (paroxetine HCI) and liquid suspension, ranging from 10 mg to 40 mg per dose. (webmd.com)
The British pharmaceutical company GlaxoSmithKline, formerly known as SmithKline Beecham, first marketed Paxil in 1992. Generic versions of the drug became available in 2003, when the patent expired. In 2013, it was approved by the FDA to treat hot flashes associated with menopause.
PAXIL (paroxetine hydrochloride) is an orally administered psychotropic drug. It is the hydrochloride salt of a phenylpiperidine compound identified chemically as (-)-trans-4R-(4'-fluorophenyl)-3S-[(3',4'-methylenedioxyphenoxy) methyl] piperidine hydrochloride hemihydrate and has the empirical formula of C19H20FNO3•HCl•1/2H2O. The molecular weight is 374.8 (329.4 as free base). The structural formula of paroxetine hydrochloride is: Paroxetine hydrochloride is an odorless, off-white powder, having a melting point range of 120° to 138°C and a solubility of 5.4 mg/mL in water.
Each film-coated tablet contains paroxetine hydrochloride equivalent to paroxetine as follows: 10 mg–yellow (scored); 20 mg–pink (scored); 30 mg–blue, 40 mg–green. Inactive ingredients consist of dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, polyethylene glycols, polysorbate 80, sodium starch glycolate, titanium dioxide, and 1 or more of the following: D&C Red No. 30 aluminum lake, D&C Yellow No. 10 aluminum lake, FD&C Blue No. 2 aluminum lake, FD&C Yellow No. 6 aluminum lake.
Suspension for Oral Administration
Each 5 mL of orange-colored, orange-flavored liquid contains paroxetine hydrochloride equivalent to paroxetine, 10 mg. Inactive ingredients consist of polacrilin potassium, microcrystalline cellulose, propylene glycol, glycerin, sorbitol, methylparaben, propylparaben, sodium citrate dihydrate, citric acid anhydrous, sodium saccharin, flavorings, FD&C Yellow No. 6 aluminum lake, and simethicone emulsion, USP.