Paxil Antidepressant Litigation
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. Paxil (generic name: paroxetine HCI) has been linked with suicide, suicidal ideation and violence in children and teenagers. Paxil has also been associated with terrible withdrawal symptoms. Paxil is most commonly used to treat depression but is also prescribed to treat anxiety, panic, obsessive compulsive disorder, and post traumatic stress disorder.
The FDA has recently issued a warning for Paxil, stating that the drug can cause suicide and violence in children and teenagers. This follows a report issued by Britain’s Department of Health which said that evidence provided by the drug company, from nine studies based on more than 1,000 youngsters, shows there is an increase in the rate of self harm and potentially suicidal behavior in those under 18 taking Paxil.
British health regulators have recently issued a warning for Paxil, stating that the drug can cause suicide and violence in children and teenagers. Following their British counterparts, Irish health officials issued a warning for Paxil in Ireland and the FDA has said it will investigate the drug further.
Britain’s Department of Health said the evidence provided by the drug company, from nine studies based on more than 1,000 youngsters, shows there is an increase in the rate of self harm and potentially suicidal behavior in those under 18 taking Paxil. The British regulators wrote in a statement “It has become clear that the benefits of Seroxat in children for the treatment of depressive illness do not outweigh these risks.”
The FDA is strengthening its warning for the antidepressant Paxil because it may be associated with birth defects, citing a new study that found increased risk of fetuses developing heart defects.
The FDA asked manufacturer GlaxoSmithKline to reclassify the drug, which goes by the generic name paroxetine, as a “Category D” drug for pregnant women. The classification means that studies in pregnant women have shown a risk to the fetus. Two studies of pregnant women taking Paxil during their first trimester have shown their babies have heart defects one and a half to two times a greater rate than the norm, the FDA said.
The FDA is advising doctors not to prescribe Paxil to women in their first three months of pregnancy or people who are planning to become pregnant, unless there are no other options.
Additionally, Paxil has long been associated with difficult withdrawal side effects, leaving patients virtually addicted to the drug. Recently, The British drug agency required Glaxo to remove a statement on its patient label saying that the drug was not addictive.
Paxil has been associated with difficult withdrawal side-effects. Often these withdrawal effects are experienced just hours after a missed dose. Paxil withdrawal symptoms include a “flu-like” syndrome, anxiety, dizziness, fatigue, headache, migraine-like feelings, nerves jangling when moving eyes, continuous indigestion, neck and back pain, psychotic features such as visual and/or audial hallucinations/illusions, insomnia, nausea, restlessness, “electrical shock” like phenomena/electrical surges or shocks through the head and/or body, hyper-sensitivity of the nervous system to light, sound, colours & stressors, tremors, tinnitus and a vertiginous-like experience, depressive thoughts, suicidal thoughts, homicidal thoughts, extreme anger, severe agitation, extreme irritability, “over-reacting”, ringing in ears and throbbing in head, vomiting, paranoia, aggressive behaviour, rollercoaster emotions rapidly following up on eachother, out of character behaviour, severe malaise, general dysphoria, derealization, panic attacks.
Two years ago, a Wyoming jury awarded $6.4 million to the family of a patient taking the pill who killed his wife, daughter and granddaughter. It is estimated that almost 17 million people worldwide have been treated with Paxil.