Paxil - Paroxetine Hydrochloride

Modified on 2009/10/14 21:46 by admin

Paxil (paroxetine hydrochloride) is part of a family of drugs called selective serotonin re-uptake inhibitors (SSRIs). Paxil is sold as Seroxat outside of the United States. With too little serotonin, people tend to harbor negative feelings about themselves and everyone around them. SSRIs such as Paxil keep serotonin circulating in the body longer and help to alleviate the symptoms of clinical depression, anxiety and other manifestations of low serotonin levels.

Paxil is prescribed for a variety of illnesses including generalized anxiety disorder, social anxiety disorder, obsessive-compulsive disorder, and depression. Recently, GlaxoSmithKline PLC applied to the Food & Drug Administration for permission to market Paxil as an effective treatment for acute social phobia, an extreme form of shyness.

Paxil and other drugs in its family have been linked to extreme acts of violent behavior in the United States and Australia. A Colorado jury awarded $8 million to the family of a man who killed himself and three family members after taking two Paxil pills.

An Australian judge ruled several weeks before the Colorado verdict that another SSRI, Sertraline, also known as Zoloft, caused a patient to kill his wife and then attempt suicide.

There is little research on the long-term effects of Paxil and other SSRIs. In addition, a class action lawsuit was recently filed alleging that Paxil is addictive, despite the manufacturer's insistence that the drug does not cause serious withdrawal complications.

In October 2003, the FDA notified healthcare professionals of reports of the occurrence of suicidality (both suicidal ideation and suicide attempts) in clinical trials for various antidepressant drugs in pediatric patients with major depressive disorder (MDD). FDA has completed a preliminary review of such reports for 8 antidepressant drugs (citalopram, fluoxetine, fluvoxamine, mirtazapine, nefazodone, paroxetine, sertraline, and venlafaxine) studied under the pediatric exclusivity provision, and has determined that additional data and analysis, and also a public discussion of available data, are needed.

In March 2004, the Food and Drug Administration issued a Public Health Advisory that provides further cautions to physicians, their patients, and families and caregivers of patients about the need to closely monitor both adults and children with depression, especially at the beginning of treatment, or when the doses are changed with either an increase or decrease in the dose.

FDA is asking manufacturers to change the labels of ten drugs to include stronger cautions and warnings about the need to monitor patients for the worsening of depression and the emergence of suicidal ideation, regardless of the cause of such worsening.

The drugs under review include bupropion, citalopram, fluoxetine, fluvoxamine, mirtazapine, nefazodone, paroxetine, sertraline, escitalopram and venlafaxine. It should be noted that the only drug that has received approval for use in children with major depressive disorder is fluoxetine (Prozac). Several of these drugs are approved for the treatment of obsessive-compulsive disorder in pediatric patients, i.e., sertraline (Zoloft), fluoxetine (Prozac), and fluvoxamine (Luvox). Luvox is not approved as an antidepressant in the United States.

Shortly after the release of the Public Health Advisory, FDA and GlaxoSmithKline notified healthcare professionals of revisions to the WARNINGS and PRECAUTIONS sections of Paxil labeling to alert healthcare professionals that patients with major depressive disorder, both adult and pediatric, may experience worsening of their depression and/or the emergence of suicidal ideation and behavior (suicidality), whether or not they are taking antidepressant medications.

The warning recommends patients being treated with antidepressants be observed closely for clinical worsening and suicidality, especially at the beginning of a course of drug therapy, or at the time of dose changes, either increases or decreases.

In June 2004, New York Attorney General Eliot Spitzer filed a lawsuit accusing GlaxoSmithKline of burying several studies that indicated Paxil was ineffective in the treatment of children and adolescents and may increase suicidal thoughts. The lawsuit, filed in New York State Supreme Court, also accuses Glaxo officials of misrepresenting data on the prescribing of Paxil to children.

In response to the lawsuit, Glaxo published the results of nine pediatric trials showing Paxil is mostly ineffective in treating children and may actually increase the risk of suicidal tendencies.

In September 2005, the FDA issued a warning detailing the results of a study that linked Paxil to birth defects. An increased number of women taking Paxil during the first trimester of pregnancy, compared with women using other antidepressants, reportedly had babies born with birth defects, including heart problems.

The FDA has determined that exposure to paroxetine in the first trimester of pregnancy may increase the risk for congenital malformations, particularly cardiac malformations. At the FDA's request, the manufacturer has changed paroxetine's pregnancy category from C to D and added new data and recommendations to the WARNINGS section of paroxetine's prescribing information. FDA is awaiting the final results of the recent studies and accruing additional data related to the use of paroxetine in pregnancy in order to better characterize the risk for congenital malformations associated with paroxetine.

In May 2006, GlaxoSmithkline updated the drug's labeling to include a warning about a recent study that showed the antidepressant may increase the risk of suicidal thoughts in younder adults taking Paxil and Paxil CR.

In 2007, the Institute for Safe Medication Practices and the Division of Public Health Sciences, Wake Forest University School of Medicine, conducted a longitudinal Adverse Events Reporting System Review of the U.S. FDA's most dangerous drugs. The study found Paxil to be one of the most dangerous drugs on the market with some of the highest number of suspect drug deaths.  Paxil was the fifteenth deadliest drug in the study, according to the FDA reports.  Over the eight years of the dangerous drug study, Paxil was found to have been involved in over 800 deaths.

As far as disability or serious outcomes are concerned, Paxil was also rated very high in the study.  During the eight years of the FDA reviewed adverse drug event reports, there were over 8,000 involving Paxil that resulted in a serious health outcome or disability.

See your doctor if you have experienced serious health problems after taking Paxil. In addition, it may be important to contact an attorney who can help you protect your legal rights. Please keep in mind that there may be time limits within which you must commence suit.

Attorneys associated with will evaluate your case free of charge. In addition, you will not pay any fees or costs unless your attorney recovers money for you. Please click on the free Ask An Attorney button to take advantage of this valuable service.

See Also

  1. Antidepressants & Other Psychiatric Drugs
  2. Addiction: Overview
  3. Balance Problems: Overview
  4. Birth Defects
  5. Depression: Overview
  6. Excessive Bleeding: Overview
  7. Nausea: Overview
  8. Violent Behavior: Overview
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