Paxil is a prescription antidepressant medication that was created and debuted by SmithKline Beecham in the early 1990s. Today the company is known as GlaxoSmithKline and is still responsible for Paxil, although the patent has expired and it is now available through other companies as a generic drug. Most people benefit from taking Paxil and many have been helped by this medication, but there have also been some issues.
GlaxoSmithKline has gotten in trouble with the U.S. Food and Drug Administration (FDA) for marketing Paxil as a valid treatment for children under the age of 18. It is now known that this drug can increase suicidal thoughts and actions in this age group. The company has also faced several lawsuits due to the effect of Paxil on unborn children when pregnant women use it and has faced recalls. If you have been hurt by Paxil, a lawsuit could help you get the compensation you deserve.
What is Paxil?
Paxil was created by SmithKline Beecham and first came on the market in 1992 after being approved by the FDA to treat depression and other conditions. The generic drug name is paroxetine, and since the patent on it ran out in 2003 it has been available from other companies. Paxil is an antidepressant, but it has also been approved for other uses. It was the first drug to be approved for treating panic disorder. It is also indicated for the treatment of other types of anxiety disorders including social anxiety disorder, generalized anxiety disorder, post-traumatic stress disorder, and obsessive compulsive disorder. It may also be prescribed to treat premenstrual dysphoric disorder and the hot flashes caused by menopause.
There are also some off-label reasons that a doctor might prescribe Paxil for a patient. These include chronic headaches, male sexual dysfunction, the tingling in the limbs that is caused by diabetes, and for treating bipolar disorder, but only in combination with other types of medication. Paxil comes in tablet form, but is also available as a liquid suspension and a timed-release tablet.
How it Works
Paroxetine belongs to a class of antidepressant medications called selective serotonin-reuptake inhibitors, or SSRIs. It works in the brain and attaches to receptors there that lead to an increase in the amount of a neurotransmitter called serotonin. This chemical messenger is implicated in mood, and people struggling with depression have less available serotonin in their brains. Drugs like paroxetine increase serotonin levels by blocking its uptake and preventing it from being recycled.
Paxil has a lot of potential side effects. For most people taking it these will be mild and will subside as the body gets used to the new medication. If you take Paxil and the side effects are severe or do not go away, they should be reported to a doctor. The most common side effects include sleepiness, nausea, tremor, dizziness, dry mouth, constipation, sweating, insomnia, loss of appetite, diarrhea, and male sexual dysfunction.
Other possible side effects include gas and stomach pain, vomiting, nervousness, trouble concentrating, yawning, a tightness in the throat, painful joints, flushing, muscle weakness, sore gums and teeth, gas, forgetfulness, headaches, heartburn, and weight loss or weight gain. More serious, but less common side effects include hallucinations, fainting, chest pain, seizures, difficulty breathing, flu-like symptoms, bloody vomit or stools, painful urination, or uncontrollable shaking. Any of these should be reported immediately and emergency medical treatment should be sought.
Suicidal Thoughts and Behaviors
One of the most troubling of all possible side effects of taking Paxil occurs only in children and young adults. For this age group there is an increased risk of having suicidal thoughts and acting on them. It is rare, but possible and life-threatening. The possibility is serious enough to warrant a black box warning on paroxetine. The FDA requires this labeling to warn patients of the risk. Children may be prescribed Paxil, but doctors are supposed to use caution and only prescribe it when it is truly needed and other treatments have not worked.
Paxil Used During Pregnancy
Paxil and other SSRIs have come under fire for potentially causing birth defects when women use them during pregnancy. Studies have found that use of Paxil, especially during the first trimester of pregnancy, may increase the risk of a miscarriage, of brain and skull defects, of an intestinal birth defect, of cleft palate, of spina bifida, and of heart defects. It may also increase the risk that an infant will be born with persistent pulmonary hypertension, a life-threatening condition.
The most recent studies of paroxetine used during pregnancy have also found a connection to developmental delays and autism spectrum disorders. The risk for autism is especially strong when women use SSRIs during the second and third trimesters of pregnancy. The risk may be as high as double.
Because of the evidence for an increased risk for birth defects, the FDA requested that GlaxoSmithKline change the pregnancy category for Paxil from C to D. This represents a greater warning that a fetus could be negatively affected by the drug. Doctors may still prescribe Paxil to pregnant patients, but are cautioned to use it only if the benefits outweigh the risks of birth defects and developmental issues.
Paroxetine is one of the most potent of all SSRIs. This means it can be most effective for treating patients, but it also intensifies the withdrawal that many patients experience when they stop taking it. These include mood swings, mania, anxiety, irritability, dizziness, confusion, tiredness, tingling in the limbs, headaches, insomnia, unusual dreams, nausea, and sweating. Withdrawal from SSRIs is called discontinuation syndrome and it can be dangerous especially if a patient stops using the medication suddenly.
Indictment and Recall
Paxil is not the only antidepressant to increase the risk of suicidal thoughts in young patients. All SSRIs carry this warning. However, GlaxoSmithKline knew of the risks and marketed Paxil to young people in spite of them. In 2012 the company pleaded guilty and was required to pay $3 billion for promoting Paxil and another antidepressant for uses that were unapproved at the time. They were also found guilty of hiding important safety data, and paying kickbacks to doctors. The company also published a journal article in which data was knowingly misrepresented regarding the effectiveness and safety of Paxil in children and adolescents.
GlaxoSmithKline has also faced issues with manufacturing of Paxil. In 2005 the company initiated a recall of certain lots of the drug made at facilities in Tennessee and Puerto Rico. The FDA investigated and found more samples of the drug that were defective. The problem was that the tablets were splitting apart, which could lead to some patients getting a lower dose or getting a drug that did not have the timed release effect that it was supposed to have.
It is not only the government that has taken GlaxoSmithKline to court over Paxil. Many lawsuits have been filed against the company, because of the effects of discontinuation syndrome, suicidal thoughts and behaviors, and birth defects. The first case against the company because of birth defects went to trial in 2009. A jury found GlaxoSmithKline guilty of failing to warn the doctor of the pregnant woman in question of the risks of birth defects. The woman’s child died because of a heart defect caused by taking Paxil. Several birth defect cases have since been settled with the company paying out more than $1 billion.
GlaxoSmithKline has also faced several suits for suicides and withdrawal symptoms and has been forced to pay out millions in those cases. If you have been harmed by taking Paxil, you still have time to make your case and to force GlaxoSmithKline to pay up for the mistakes made