Paroxetine is a drug that is manufactured and distributed by the British company GlaxoSmithKline (GSK). Although it's most commonly known by the brand name "Paxil," the drug is also sold under the names Aropax, Pexeva, Seroxat, Sereupin, and Brisdelle. Paxil is used to treat a variety of psychiatric conditions, including depression, obsessive-compulsive disorder, anxiety disorders, and post-traumatic stress disorder. It's a "selective serotonin reuptake inhibitor" (SSRI), meaning the drug is designed to increase the brain's exposure to the neurotransmitter serotonin.
Over the years, Paxil has come under scrutiny for a number of serious complications linked to the drug. As a result, GSK has spent millions in lawsuit settlements, and recently agreed to pay $8 billion in fines for fraudulently marketing several of its products, including Paxil.
Paxil Withdrawal Syndrome
The first wave of lawsuits related to Paxil were based on allegations that GSK promoted the drug as being non-habit forming, when in fact the company reportedly knew about severe withdrawal symptoms as early as 1993. The most commonly reported withdrawal symptoms include anxiety, insomnia, irritability, nausea, and fatigue. Cases filed in U.S. federal courts were consolidated into a multidistrict litigation proceeding in the Central District of California. The cases were settled for a reported $160 million, and the MDL was closed in February of 2006.
Paxil Linked to Suicide
On September 23, 2004, the FDA released a statement warning about the possible risk of increased suicidal ideation and behaviors in young users of antidepressant medications, including Paxil. In 2007, the FDA ordered the manufacturers of 32 antidepressant drugs, including GSK, to amend their black box warnings to include increased risk of suicide in children. Finally, on May 2, 2007, the FDA issued a statement proposing that makers of all antidepressant medications further update their black box warnings to reflect a heightened risk among users aged 18-24 years.
The first suicide Paxil lawsuit to go to trial in the U.S. involved an adult patient. The case was tried in a federal court in Wyoming, and the jury awarded an $8 million verdict in favor of the family of a man who killed his wife, daughter, and granddaughter before taking his own life after using Paxil for two days. Significant litigation followed that trial, with most cases settling.
Birth Defect Litigation
When Paxil was introduced in 1992, it was classified as a drug with no known link to increased birth defects. However, that classification turned out to be inaccurate, and on December 8, 2005, the FDA issued a warning about early results in a study which suggested Paxil use by pregnant women in the first trimester of pregnancy increased the risk for birth defects, especially heart defects. One of the most commonly reported birth defects involved holes in the walls of the heart's chambers.
A number of Paxil lawsuits have been filed against GSK over birth defects. Many of these suits have been consolidated into a court in Philadelphia, which is home to one of GSK's U.S. headquarters. The first birth defect case was tried in Philadelphia in 2009, with the jury awarding a $2.5 million dollar verdict in favor of the plaintiff.
Paxil Lawsuits: Get a Free Claim Review
It is anticipated that injured consumers will continue to sue GSK over issues related to Paxil use into the foreseeable future. If you think you or your child has sustained an injury related to the use of Paxil, you can get the facts of your situation reviewed, for free, by an experienced attorney who is knowledgeable about Paxil litigation. It's important to note that the law limits the time in which a product liability lawsuit may be brought against a manufacturer.
Contact a qualified product liability attorney to make sure your rights are protected.