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Paxil Birth Defects Lawsuit
Paroxetine is commonly known as Paxil, and is a prescription drug used for treating severe depression. It is manufactured by GlaxoSmithKline (GSK). It belongs to the selective serotonin reuptake inhibitor family (SSRI), and is used in treating obsessive-compulsive disorder, panic attacks, post traumatic stress disorder and general anxiety. When levels of serotonin are reduced, depression often results. Paxil operates to regulate serotonin levels and stabilize a depressed or anxious person’s temperament.
After being approved by the U.S. Food and Drug Administration, Paxil arrived on the market in 1992. It has been widely prescribed. In 2004, the FDA mandated a black-box warning for the drug, advising of increased risk “of suicidal thinking and behavior in children, adolescents and young adults.” A black box warning is the most serious warning that can be given for a prescription medication. The warning was required after evidence indicated that Paxil’s side effects included violent behavior and aggression that could lead to suicide. Over 400 lawsuits involving attempted and completed suicides allegedly connected with Paxil have been filed and settled.
The manufacturer of Paxil was also been the target of class action lawsuits involving the drug’s potential for addiction. Severe symptoms of withdrawal and addiction to Paxil have been reported. The manufacturer has been accused of intentionally withholding information regarding drastic withdrawal symptoms. Although the manufacturer alleges there is no reliable evidence supporting the drug’s potential addiction, lawsuits alleging addiction have been settled. In 2002 an FDA warning was published advising of severe discontinuation symptoms that included obvious agitation. It has been recommended that if a person is to disconinue use of the drug, it should be done by decreasing dosages for weeks or months at a time.
A significant number of other lawsuits have been filed against Paxil’s manufacturer alleging heart defects in babies that were alleged to be connected to use of the drug during pregnancy. An FDA alert was issued in 2005, advising that doctors should “consider discontinuing Paxil (and switching to another antidepressant if indicated) in these patients.”
In 2006, the American College of Obstetricians and Gynecologists recommended that women planning pregnancies should avoid the drug. The FDA also disclosed that preliminary results of two studies indicated that when Paxil was taken by women in the first three months of pregnancy, they were about one and a half to two times as likely to give birth to a baby with a heart condition as women using other such medications or the female population in general. Evidence strongly points to babies being born with holes in the ventricular walls of the heart. These are known as ventricular septal defects. Although the septal defects range in severity, many of them can only be repaired with surgery. The FDA then requested that Paxil’s manufacturer reclassify Paxil and disclose that the drug poses a risk to a fetus. The manufacturer relented and made that disclosure.
Other studies strongly suggested that Paxil was connected with persistent pulmonary hypertension of the newborn (PPHN). A study was published in the New England Journal of Medicine in February of 2006 suggesting that medications such as Paxil were linked to PPHN when the medication was used during the last trimester of pregnancy. The study found that babies were six times more likely to be born with PPHN than babies whose mothers did not use SSRIs. The report found that up to 12 newborns out of every 1,000 developed pulmonary hypertension after their mothers used SSRIs during pregnancy. PPHN results in oxygen deprivation in the lungs and heart. About 20 percent of babies with PPHN don’t survive. Many that do survive have breathing problems for life.
In 2012 GSK entered a guilty plea and agreed to pay $3 billion to resolve both civil and criminal liability in the largest healthcare fraud case in United States history. Part of its plea involved allegations that it misbranded Paxil and introduced it into the market for pediatric use while not having approval for such use. It published false reports of efficacy for Paxil with patients under the age of 18, and failed to make data available of Paxil’s efficacy or lack of it from two other studies. Then they wined and dined doctors and others with spas, ski trips, jaunts to Jamaica and Bermuda, pheasant hunting in Europe and Madonna concerts, while soliciting the doctors to write prescriptions for use of Paxil outside of the drug’s permitted use. The manufacturer agreed that it misbranded Paxil, and that its labeling was false and misleading in the context of patients under 18 years of age. It admitted that fact in a guilty plea.
It was also alleged the GSK falsified the efficacy of the drug in one study while withholding results of two other studies that made the Paxil’s efficacy highly suspect. One study found that teens that took Paxil for depression were more likely to attempt suicide than those who took a placebo. GSK then hired a ghostwriting company to prepare an article for a medical journal that misrepresented the study’s finding. GSK subsequently agreed that labeling of the product as being safe for people under 18 was false and misleading.
Notwithstanding the risks of suicide ideation or completion and severe birth defects, Paxil remains on the market. If you believe that you, a member of your family, or a loved one has been adversely affecte by Paxil, it doesn’t cost anything to contact us to discuss your concerns and obtain additional information.