GlaxoSmithKline, a large drug company based in the United Kingdom, first developed and brought Paxil to market in the 1990s. The patent on this brand name drug expired in 2003 and it is now available as several generics. Paxil was created to treat depression, but is also sometimes used for anxiety disorders. GlaxoSmithKline made a lot of money from Paxil, but also has faced a number of lawsuits over complications it can cause and illegal marketing of the medication.
Paxil has been shown to be linked to an increased risk of suicidal thoughts and self-harm in young patients, and marketing the drug to this demographic got GlaxoSmithKline into a lot of trouble. Additionally, the medication has been linked to birth defects, autism, and a serious condition called discontinuation syndrome. These have led to a number of Paxil lawsuits brought by individuals who believe they were not warned of the risks.
What is Paxil?
Paroxetine is the generic name of Paxil and it belongs to a class of antidepressants called selective serotonin reuptake inhibitors, or SSRIs. Paroxetine is indicated for the treatment depression, generalized anxiety disorder, panic disorder, social anxiety disorder, obsessive compulsive disorder, and post-traumatic stress disorder. Off-label it may be used to treat premenstrual dysphoric disorder or certain symptoms of menopause.
As an SSRI, Paxil works in the brain by blocking the reabsorption of a neurotransmitter called serotonin. This brain chemical is thought to be at low levels in people struggling with depression or anxiety, so blocking its reabsorption boosts mood in some patients. There are some common side effects that Paxil may cause, although mostly they are not serious. These include insomnia, constipation, nausea, appetite loss, sexual dysfunction, dizziness, tremors, and diarrhea.
Reasons to File a Paxil Lawsuit
A lot of Paxil lawsuits have been filed since this drug debuted in the 1990s. Most people who take Paxil experience only mild, moderate, or no side effects, but some have been seriously harmed by the drug. These people believe that GlaxoSmithKline did not do enough to warn them that there were such serious risks associated with taking paroxetine.
These risks include increased suicidal thoughts, which in some cases have led to harm and even death, discontinuation syndrome, which makes people very sick if they stop taking the drug too abruptly, and even the presence of birth defects and later autism diagnoses in the children of women who took Paxil while pregnant.
All SSRIs, and even other classes of antidepressant drugs, have been found to be connected to a risk of suicidal thoughts, but only in patients 24 and under. The U.S. Food and Drug Administration (FDA) requires that these drugs carry a very strong warning about it and recommend that patients under 18 are not given Paxil or other SSRIs. In some cases a doctor may take the risk and prescribe it to a young patient, but only if other options have been exhausted.
Although the FDA instituted the mandatory warning about suicide in young patients, that warning only came in 2007, which is more than a decade after Paxil had been in use. Some lawsuits against GlaxoSmithKline and other makers of antidepressants claim that the drug companies did not do enough to warn patients sooner and more effectively and that young people suffered as a result.
Another major issue with Paxil and other antidepressants is the fact that discontinuing use of the mediation can lead to serious, dangerous, and uncomfortable withdrawal symptoms. Drug makers claim that antidepressants are not addictive and yet patients stopping their use suddenly experience severe mood swings, confusion, nightmares, nausea, excessive sweating, tingling sensations, headaches, anxiety, irritability, and mania.
The FDA has warned the public about this possibility, but as with suicidal thoughts in children and teens, many people believe the warning has not been strong enough. Patients are not supposed to stop taking Paxil suddenly and without a doctor’s guidance, but a lot of them say that they didn’t know about how serious the consequences of doing so could be. This is yet another reason that GlaxoSmithKline is facing lawsuits regarding Paxil.
Birth Defects and Developmental Disorders
Perhaps most controversial of all, and the number one reason to file a Paxil lawsuit, is that this antidepressant has been linked to birth defects, and more recently to autism in children. Evidence from studies and reports from individuals both show that there is a definite connection between the drug and birth defects, especially when a woman takes Paxil during the first trimester. Birth defects seen in children born to women who took the drug include intestinal defects, brain and skull defects, spina bifida, cleft palate, and heart defects.
These vulnerable young babies are also at a greater risk for a serious and life-threatening condition called pulmonary hypertension of the newborn. Mothers who took Paxil are also more likely to suffer a miscarriage. Most recently Paxil has been implicated in an increased risk that a child will eventually be diagnosed with an autism spectrum disorder. The risk is especially great when a mother takes Paxil during the second and third trimesters of her pregnancy.
The risks are now well-known, but that information came too late for some women who did not have all the facts as they weighted the benefits and risks of taking an antidepressant while pregnant. The FDA has recognized the risk and has requested that GlaxoSmithKline upgrade the pregnancy category from C to D to better communicate Paxil’s risks to unborn children.
Off-Label Promotion Lawsuit
All of these risks that come with taking Paxil have spurred lawsuits from individuals harmed by the drug. The company has also faced lawsuits brought by the government, particularly for illegal marketing. GlaxoSmithKline was found to have been promoting the use of Paxil in children and teens, in spite of the known risks of suicide. To market a drug for off-label uses is illegal, even though doctors may use their professional judgment to prescribe drugs off-label.
The company pleaded guilty to the charge of off-label marketing in 2012 and was forced to pay $3 billion. In addition to the illegal marketing, GlaxoSmithKline was also found in the case to have paid kickbacks to doctors to promote more prescriptions of Paxil and of misrepresenting trial data, hiding data, and making Paxil seem safer than it really is.
Other Paxil Lawsuits
Thousands of individuals have filed lawsuits over Paxil’s dangerous side effects. Most of these have come from parents of children born with birth defects and behavioral challenges. There is evidence that GlaxoSmithKline may have known more about the risk of birth defects, long before the information was made public. Individuals filing these suits want to hold the company accountable and believe that it is negligent in their children’s defects.
Many of the suits are ongoing, but some have been settled. One example of a resolved case occurred in 2010. A jury in Philadelphia ordered GlaxoSmithKline to pay $2.5 million to a family whose son was born with a heart defect. The jury found that the company was guilty of failure to warn and negligence. In this case the plaintiff and their legal team had internal documents proving that individuals within the company tried to bury the studies linking Paxil to birth defects.
This is just one of many examples. The average settlement that people are getting from GlaxoSmithKline over birth defects is $125 million, a huge amount. The amount reflects the severity of the damage the company has caused to the youngest possible victims. The high amounts also reflect the fact that the company was found to be negligent in these cases. If you have suffered from Paxil, or a loved one has suffered, you may be able to make a case that would land you a significant settlement. GlaxoSmithKline has already been seen to be negligent in several ways, and that means that future plaintiffs may have strong cases against the company.