Paxil, paroxetine, belongs to a class of drugs called selective serotonin reuptake inhibitors (SSRIs). Manufactured by the pharmaceutical company GlaxoSmithKline (GSK), this prescription drug sold in tablet form was approved for use by adults in 1992 by the U.S. Food and Drug Administration (FDA) to treat depression, obsessive-compulsive disorder (OCD), social anxiety, panic disorder, post-traumatic stress disorder (PTSD), premenstrual dysphoric disorder (PMDD), and other generalized disorders linked with anxiety. In 2006, Paxil was the fifth most recommended antidepressant with more than 18 million prescriptions, and in 2007, it was ranked among the 100 best-selling drugs in the United States, with sales of more than $1 billion.
Researchers believe that serotonin regulates mood. Serotonin, manufactured in the brain but mainly stored in the gut and central nervous system, is a neurotransmitter—a chemical that transmits impulses between nerve cells. Low levels of serotonin cause depression, anxiety, and listlessness, and SSRIs, like Paxil, work by inhibiting the “reuptake” or absorption of serotonin, thus allowing for reduced symptoms. Studies clearly demonstrate Paxil’s effectiveness as an antidepressant is better than its predecessors, but there is also an increased risk of severe complications after extended use.
Extreme Withdrawal Symptoms
Large numbers of users of Paxil experience extreme withdrawal symptoms with the interruption, reduction, or discontinuation of the drug. Symptoms are both physical and psychological in nature:
- Sleep disturbances
- Gastrointestinal problems
- Flu-like symptoms
- The feeling of “electric zaps” throughout the body
- Confusion and anxiety
- Panic attacks
- Uncontrollable moods
- Depression and suicidal ideations
- Aggressive thoughts and actions
The Medicines and Healthcare Regulatory Agency (MHRA), the British equivalent to the United State’s FDA, mandated a labeling change by GSK in 2003 after countless reports of extreme withdrawal symptoms were submitted by users. GSK was required to change the label so that it could no longer claim that Seroxat, the British equivalent of Paxil, is non-addictive. Unfortunately, the FDA has yet to mandate the same requirements in the United States, even though thousands have experienced addiction-like withdrawal from Paxil. Previously filed lawsuits claim that GSK knowingly failed to warn patients and physicians about these serious and life-altering episodes.
Suicidal Thoughts in Children under 18
Antidepressants are associated with an increased risk of suicidal thinking especially in children and teenagers. Studies confirm there is a higher frequency of suicidal behavior in children and teens (ages 1-18) and young adults (ages 18-24) taking Paxil compared to those taking a placebo or those in a higher age group (ages 25-65). According to the FDA, in June 2003, after GSK was required to re-evaluate the data collected from prior studies, the MHRA mandated that Seroxat (Paxil) “should not be used in children and adolescents under the age of 18 years to treat depressive illness,” and instituted a labeling change on the drug. Shortly thereafter, the FDA responded: “Although FDA has not completed its evaluation of the new safety data, FDA is recommending that Paxil not be used in children and adolescents for the treatment of [major depressive disorder].” Even though the FDA has never approved Paxil for patients under 18, GSK was found to have continuously promoted Paxil prescriptions for children and teens. On July 2, 2012 the Department of Justice issued a statement confirming that GSK agreed to pay $2 million to settle a government suit filled against the company under the False Claims Act. The government alleged that “from April 1998 to August 2003, GSK unlawfully promoted Paxil for treating depression in patients under age 18, even though the FDA has never approved it for pediatric use.” Additionally, the government contends that GSK encouraged doctors to attend meetings where speakers touted the efficacy of the drug in patients under 18—even though their own studies failed to support these claims and the FDA required “black box warnings” on Paxil for users under 18
Women who are pregnant while using Paxil have a higher rate of delivering newborns with congenital birth defects like omphalocele (organs are located outside of the body), hydrocephalus (water on the brain), and craniosynostosis (misshapen head). The FDA in a news release on December 8, 2005, stated that women taking Paxil in the first three months of pregnancy have a “one in a half to two times higher risk” of bearing a child born with heart defects than those not taking Paxil. Children are more likely to be born with atrial and ventricular septal defects, holes in the wall of the heart chamber. After this report, the FDA changed Paxil’s Category C classification to a Category D classification, indicating the drug poses a risk to the fetus. Additionally, the New England Journal of Medicine published a study in February 2006 that reported babies born to mother’s taking Paxil after the twentieth week of pregnancy were “6 times more likely to have PPHN [persistent pulmonary hypertension] than other infants not exposed to an SSRI antidepressant during pregnancy.”
Have You Been Affected by Paxil?
Any individual or the relative of an individual who has suffered due to Paxil’s side effects is permitted to file a lawsuit. The lawyers can help you determine whether you are qualified to seek compensation. You may be eligible to seek reimbursement for medical expenses, compensation for pain and suffering, and punitive damages (compensation granted for losses suffered).
Different states have different legislation regarding medical lawsuits, so it is essential to hire an experienced and effective lawyer who can file the case. If you need further information about the harmful side effects of Paxil or legal advice concerning personal injury matters, you are invited to fill out the form on this website for a free case evaluation.