Paxil is a popular antidepressant that hit the market in 1992. It can cause serious birth defects if taken during pregnancy.
Paxil is the trade name of the medication paroxetine, which is prescribed to treat major depression and other psychological pathologies that include panic disorder, obsessive-compulsive disorder, social anxiety, generalized anxiety disorder and posttraumatic stress syndrome.
The drug is also used for premenstrual dysphoric disorder (physical and psychological symptoms that occur before the onset of a woman’s menstrual period), chronic headaches, tingling in the hands and feet caused by diabetes and (with other medications) bipolar disorder.
Paroxetine is one of the most potent and selective of the SSRI (selective serotonin reuptake inhibitor) type drugs. SSRIs work by preventing receptors in the human brain from reabsorbing already released serotonin, the neurotransmitter that is understood to help people maintain feelings of well-being. By preventing serotonin reabsorption, Paxil helps people sustain an optimistic mental equilibrium while alleviating negative feelings.
Paxil was first marketed in 1992 by SmithKline Beecham, a British pharmaceuticals company that is now GlaxoSmithKline (GSK) following a series of corporate mergers. The U.S. Food and Drug Administration (FDA) approved Paxil for the U.S. market in 1992, and by 2007 it was the fifth-most prescribed antidepressant drug in the U.S. with more than 18 million yearly prescriptions.
Like other SSRI drugs, Paxil carries side effects that range from irritating (drowsiness) to problematic (sexual dysfunction) to severe (suicidal thoughts and birth defects). The FDA issued a black-box warning for the drug related to the link to suicide. In addition, GlaxoSmithKline experienced numerous legal problems and settled claims for repackaging and mislabeling Paxil; engaging in sham litigation to forestall generic manufacturing of the drug; withholding Paxil safety information; and promoting Paxil unlawfully to children.
Paxil’s Side Effects
|Like many other SSRI drugs, Paxil can cause one or more harmful physical and mental side effects including:|
|Some of Paxil’s side effects can be extremely serious. Any of the following symptoms requires immediate medical attention:|
|Problems with balance or coordination||Confusion|
|Hallucinations||Racing or abnormal heart rate|
Serious Side Effects of Paxil
Paxil and Pregnant Women
Paxil also causes two other significant side effects: complications for pregnant women, including the risk of serious birth defects, and increased thoughts of suicide in its users.
|When taken by pregnant women, especially during the first trimester, Paxil may cause the following:|
|Persistent Pulmonary Hypertension (PPHN) – a life-threatening condition in which high pressure in a child’s lung’s blood vessels results in insufficiently oxygenated blood||Premature birth|
|Miscarriage||Hypoplastic Left/Right heart Syndrome (HLHS)|
|Septal heart defects||Cleft lip or Cleft palate|
|Cranial (brain and skull) defects||Spina Bifida|
|Omphalocele – a birth defect in which the infant’s intestine or other abdominal organs stick out of the navel||Club Feet|
The American College of Obstetricians and Gynecologists recommends that pregnant women, and women planning to become pregnant, avoid the use of paroxetine, if possible, because of an increased risk of cardiovascular malformations and spontaneous abortion.
In 2005, the FDA asked GSK to change the pregnancy category from C to D – a stronger warning – on its product labeling, based on studies that demonstrated a risk to the fetus by pregnant users.
Paxil and Suicide – Black Box Warning
In 2004, an FDA panel voted to require manufacturers of all antidepressant drugs to add a black-box warning to their product labeling. A black-box warning is the most serious warning placed on the labeling of a prescription medication.
In this case, the FDA mandated that the labels on Paxil and other SSRIs state clearly that taking the drugs “increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders.” Further, the warning stated that anyone who takes the medication because of issues of depression should be watched closely for signs of suicidal behavior and other significant behavioral changes.
Approximately 5,000 people in the United States filed lawsuits against GlaxoSmithKline since Paxil became available. Some of these claims were class-action suits. The company has paid billions of dollars to resolve litigation related to birth defects, withdrawal and suicides.
A Paxil lawsuit may be filed by anyone who discovers or suspects that the drug has caused serious side effects, or who has a child who was born with a serious birth defect after a pregnant woman used Paxil during her pregnancy. Those families who are affected should contact a reputable defective products attorney to see if they are eligible for compensation for pain and suffering, lost earnings, and/or medical treatment.
In October 2009, the first birth defect case against the drug manufacturer went to trial, and a Philadelphia jury found that GlaxoSmithKline “negligently failed to warn” a doctor treating a pregnant woman about Paxil’s risks and that the drug was a “factual cause” of her son’s fatal heart defects. The family was awarded $2.5 million. By July 2010, the drug company had settled approximately 800 Paxil birth defects lawsuits at a cost of $1.14 billion.
GSK paid an average of about $50,000 per case to resolve approximately 3,200 claims linking Paxil to addiction problems. Plaintiffs claimed that they were not sufficiently warned about the drug’s withdrawal problems and that GSK had specifically advertised the drug as non-habit forming. The drug company also paid $390 million for suicides or attempted suicides said to be linked to the drug, but few if any of these cases are now being filed related to suicide.
Paxil Manufacturer, Criminal Indictment and Recall
In the largest health care fraud settlement in U.S. history, GlaxoSmithKline in 2012 agreed to plead guilty to a three-part criminal indictment and pay $3 billion in fines and civil penalties for promoting two drugs – Paxil and Wellbutrin – for unapproved uses, including the treatment of children and adolescents, a tactic known as “off-label marketing,” and for failing to report safety data about its diabetes drug, Avandia, to the FDA.
In addition, the drugmaker was found guilty of paying kickback to doctors and, according to federal prosecutors, “using every imaginable form of high-priced entertainment from Hawaiian vacations, paying doctors millions of dollars to go on speaking tours, to tickets to Madonna concerts.” In the case of Paxil, prosecutors alleged GlaxoSmithKline helped publish a medical journal article that misrepresented data from a clinical trial and exaggerated Paxil’s ability to treat depression in adolescents.
As part of the settlement, the drugmaker, which did not admit any wrongdoing in the civil settlement, is to be monitored by government officials for five years. While the penalties were the largest ever levied, critics contended they were still not enough to deter pharmaceutical companies from unlawful behavior.
In the period covered by the settlement – the late 1990s to the mid-2000s – GlaxoSmithKline sold $10.4 billion worth of Avandia, $5.9 billion worth of Wellbutrin and $11.6 billion worth of Paxil. A $3 billion settlement was less than 15 percent of revenues for the three drugs.
GlaxoSmithKline in 2005 voluntarily recalled several lots of its Paxil CR because of manufacturing problems at its facilities in Knoxville, Tennessee, and Cidra, Puerto Rico. Several months later, the FDA seized more remnants of the suspect lots after determining that the tablets could split apart causing some patients to receive a portion that lacks any active ingredient, or alternatively a portion that contains the active ingredient but does not have the intended controlled-release effect. GSK continued production and distribution from the two plants several months after the recall.