Personal Injury Lawyers

Paxil / Paroxetine Hydrochloride

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 thepediatric 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.

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.

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-- Article Courtesy of InjuryBoard.com

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