Paxil Lawsuits and Legal Information

Paxil (paroxetine hydrochloride) is an antidepressant drug. Paxil is the brand name for paroxetine. GlaxoSmithKline (GSK) manufactures the drug and markets it for the treatment of depression. The U.S. Food and Drug Administration (FDA) approved the drug in 1992.

Doctors prescribe Paxil to help patients with several mental health disorders. While the drug has many side effects, it has proven to be as safe as many alternative prescription drugs, such as Prozac (fluoxetine).

Paxil is an FDA-approved drug, but over the years, clinical trials and research studies have shown that there are serious adverse effects.

This article briefly discusses Paxil’s side effects. It also provides a timeline of notable Paxil research and legal updates. At the end of the article, you’ll find information on how to get legal help if you’ve been harmed by Paxil.

What Conditions Does Paxil Treat?

Doctors prescribe Paxil (paroxetine hydrochloride) to treat a variety of mental health conditions. It’s one of the most popular antidepressant drugs on the market.

The FDA approved the use of Paxil to treat the following disorders:

• Major depressive disorder
• Panic disorder
• Social anxiety disorder (SAD)
• Obsessive-compulsive disorder (OCD)
• Posttraumatic stress disorder (PTSD)
• Generalized anxiety disorder (GAD)
• Premenstrual dysphoric disorder (PMDD)

These are the only uses the FDA approved for Paxil. Some doctors prescribe the drug for off-label uses, such as sleep disorders. An off-label use is one that the FDA hasn’t approved.

Who Shouldn’t Take Paxil?

Some people should avoid taking Paxil. Pregnant women and women who are breastfeeding should not take this medication. Clinical trials have shown that women taking Paxil during pregnancy risk having a baby with cardiovascular malformations and other congenital disabilities. Patients with kidney disease and renal failure should also avoid taking Paxil and other SSRIs.

The FDA has also warned doctors to be careful when prescribing Paxil to older adults. Studies have shown that older patients taking Paxil face life-threatening health risks. The FDA has also warned about prescribing Paxil to pediatric patients under 8.

People who take specific drugs must avoid Paxil due to dangerous drug interactions. These include:

• Risperidone
• MAOIs
• NSAIDs
• Warfarin
• Thioridazine

Tell your doctor about any drugs, including over-the-counter medications and supplements.

Adverse Health Risks of Paxil

Besides common side effects, Paxil has other health complications. The risks of using Paxil include:

• An increased risk of suicidal thoughts or actions
• Serotonin syndrome
• Increased risk of suicide
• Persistent Pulmonary Hypertension of the Newborn (PPHN)
• Bleeding problems
• Mania
• Seizures
• Sexual dysfunction

Tell your doctor about all known medical conditions. This is especially true for patients with liver disease, kidney disease, or glaucoma.

Don’t stop taking Paxil suddenly. Doing so may result in harmful side effects, including Paxil withdrawal syndrome. Your healthcare professional should slowly decrease your dose as necessary.

Paxil and Serotonin Syndrome

In July 2006, the FDA issued an alert stating that a life-threatening condition called serotonin syndrome can happen when patients take both Paxil and triptans. Triptans are prescription medications doctors use to treat migraines. The FDA ordered drug companies that manufacture SSRIs, such as Paxil, to add a warning to their product labels.

Signs and symptoms of serotonin syndrome include:

• Restlessness
• Hallucinations
• Loss of coordination
• Fast heartbeat
• Increased body temperature
• Rapid changes in blood pressure
• Overactive reflexes
• Diarrhea
• Coma
• Nausea
• Vomiting

Serotonin syndrome may be more likely to happen when you first start taking Paxil. If you take migraine headache medicines, ask your health care professional if your medicine is a triptan.

Paxil, Antidepressants, and Pregnant Women

In July 2006, the FDA issued an alert announcing the results of a study looking at the use of antidepressant medicines during pregnancy in mothers of babies born with a severe condition called persistent pulmonary hypertension of the newborn (PPHN).

Babies born with PPHN have abnormal blood flow through the heart and lungs and do not get enough oxygen to their bodies. Babies with PPHN can be very sick and may die.

In 2011, the FDA updated its public health advisory. According to the update, studies between 2006 and 2011 offered conflicting results on PPHN and SSRIs. But, the FDA didn’t tell drug manufacturers to remove their warnings.

Paxil and Increased Risk of Suicidality

In October 2004, the FDA issued a public health advisory directing all antidepressant drug manufacturers to revise their product labeling to include boxed warnings about an increased risk of suicidality in adolescents taking SSRIs.

Paxil-maker GlaxoSmithKline added a black box warning to Paxil prescribing information in response to the FDA advisory.

In June 2005, the FDA issued a public health advisory announcing that recent studies suggested the possibility of an increased risk for suicidal behavior in adults taking antidepressant medications, including Paxil.

The FDA advised that loved ones should track the behavior of adults taking antidepressants. Family members must look for signs of worsening depression and increased suicidality. Monitoring these patients is especially important when treatment begins and when doctors increase or decrease a patient’s dose.

In May 2006, Glaxo and the FDA notified health care professionals of changes to the Clinical Worsening and Suicide Risk subsection of the warnings section of prescribing information for Paxil and Paxil CR. These labeling changes concerned young adults taking Paxil.

In recent years, studies have shown that this risk of suicidality may not be valid. In a 2019 study appearing in Frontiers of Psychiatry, researchers suggested that taking antidepressants may reduce a young person’s risk of suicide.

Paxil Withdrawal Syndrome

The first wave of Paxil lawsuits involved allegations that GSK promoted the drug as being non-habit-forming, knowing there was a risk of severe withdrawal symptoms. Plaintiffs argued that the drug company knew about these risks as early as 1993.

The courts consolidated these federal Paxil lawsuits into a multidistrict litigation (MDL) in the Central District of California. GSK settled these class action lawsuits for $160 million. The courts closed the MDL in February 2006.

Congenital Abnormalities Litigation

When Glaxo introduced Paxil in 1992, the FDA classified it as a drug with no known link to increased congenital abnormalities. But, the FDA learned that its classification was inaccurate.

On Dec. 8, 2005, the FDA issued a warning about a study suggesting that pregnant women taking Paxil in the first trimester had an increased risk of congenital abnormalities, especially heart defects. One of the most common side effects of Paxil for pregnant women involves holes in the walls of their baby’s heart’s chambers.

Several plaintiffs filed Paxil lawsuits after their infants developed congenital disabilities. The court consolidated most of these cases into MDL in Philadelphia. This city is home to a GSK headquarters.

Attorneys first tried these cases in 2009. The jury awarded the plaintiffs $2.5 million. In a recent class action lawsuit in Vancouver, Canada, GSK agreed to pay C$6.2 million to 50 plaintiffs alleging that the drug company failed to warn of suicidal risks.

As of 2024, the total settlements for congenital abnormality cases were up to $2 billion.

Fraudulent Marketing Settlement

In 2012, the New York attorney general accused Glaxo of illegally marketing Paxil to young children. The state claimed that the drugmaker bribed doctors to prescribe the drug to children with depression and anxiety. This was in direct violation of the FDA’s warnings not to prescribe the drug to children under 8.

GSK settled the criminal charges and agreed to pay a fine of $3 billion.

Paxil Suicide Lawsuits

Over the years, thousands of plaintiffs have sued GSK over Paxil’s increased risk of suicide. Many of these lawsuits appeared around the same time the attorney general of New York pursued the drugmaker for fraud.

In 2012, a woman named Wendy Dolin sued GlaxoSmithKline after her husband jumped in front of a commuter train. Dolin argued that her spouse, Stewart Dolin, was taking a generic version of Paxil at the time of his death.

Initially, the jury awarded Dolin $3 million. But, in August 2018, the court of appeals set aside the verdict. The judge said the courts could not hold GSK responsible for patients who died while taking generic versions of Paxil.

To date, GSK has paid more than $390 million to settle class action lawsuits about Paxil’s increased risk of suicide in young people and adults.

Timeline of Paxil Research and Legal Updates

Below, in reverse chronological order, you’ll find significant news, research, and legal updates for Paxil.

June 2019: Study Shows Strong Correlation Between Long-Term Use of Paxil and Dementia

In 2019, British researchers at the University of Nottingham in England found that older patients who took Paxil were more likely to develop dementia. The team found that patients who took these drugs for over three years had a 50% increase in dementia diagnoses.

2014: Study by Mayo Clinic Confirms 6 Side Effects of Paxil

Researchers at the Mayo Clinic conducted a study to determine the severe side effects of Paxil. They found that many patients taking the drug gained significant amounts of weight. They also confirmed an increased frequency of suicidal thoughts, especially in young patients.

This study also found that Paxil causes gastrointestinal issues in patients due to low sodium levels. Some patients’ kidneys and liver cannot metabolize Paxil properly, which causes a change in sodium levels.

January 2007: Study Links Antidepressants to Bone Fractures in Older Patients

A 2007 study found that the use of certain antidepressants by older patients exposed them to an increased risk of bone fractures. This Canadian study found that patients who take Paxil, Prozac, or Zoloft are twice as likely to suffer bone fractures.

December 2006: FDA to Review Suicide Risk for Young Adults Taking Antidepressants

The U.S. Food and Drug Administration (FDA) announced an increased risk of suicidal thoughts in young adults and pediatric patients who took Paxil. It also said it would change antidepressant drug labels based on the panel’s findings.

November 2006: Physicians Tell Pregnant Women to Avoid Paxil

American College of Obstetricians and Gynecologists said doctors should decide which medications to prescribe to pregnant women on a case-by-case basis. This includes Lexapro, Paxil, Prozac, and Zoloft.

October 2006: Paxil Lawsuit Reaches $63.8M Settlement

An Illinois class-action lawsuit over the alleged fraudulent promotion of the antidepressant Paxil settled. Paxil manufacturer GlaxoSmithKline agreed to pay $63.8 million in damages. It refused to admit liability.

The class-action lawsuit alleged that GlaxoSmithKline promoted child and adolescent use of Paxil without fully disclosing the drug’s safety risks. As part of the settlement, people who bought Paxil or Paxil CR for their children or teens could get a sales price refund.

July 2006: Lawsuit Filed on Behalf of Child With Severe Heart Birth Defects

The parents of a 2-year-old child with severe congenital heart disabilities sued GSK in Pennsylvania state court. Plaintiffs alleged that Paxil caused their son’s congenital disabilities. They also alleged that GSK failed to warn about the risks of Paxil during pregnancy.

July 2006: FDA Issues Two Alerts About Paxil Use

The Food and Drug Administration issued two alerts about Paxil use. The first alert announced the risks associated with the combined use of selective serotonin reuptake inhibitors (SSRIs, such as Paxil) and triptans (used to treat migraine headaches). The second alert announced the risks of taking SSRIs during pregnancy.

May 2006: GlaxoSmithKline Announces Changes to Paxil Prescribing Information

GlaxoSmithKline and the FDA notified health care professionals of changes to the Clinical Worsening and Suicide Risk subsection of the “WARNINGS” section of Paxil and Paxil CR. These labeling changes relate to adult patients, particularly young adults.

Results of the drug maker’s recent analysis of Paxil in adult patients showed a higher frequency of suicidal behavior in young adults. The FDA said people should interpret the results cautiously since the absolute number and incidence of events were minor.

All reported events of suicidal behavior in adult patients with major depressive disorder (MDD) were non-fatal suicide attempts. The majority of those attempts (eight of 11) were in younger adults ages 18-30.

June 2005: Suicidality in Adults Taking Antidepressant Medications

The FDA issued a public health advisory. It announced that several recent scientific publications suggested an increased risk for suicidal behavior. The risk is in adults taking antidepressant medications, including Paxil.

The FDA advised that adults taking antidepressants beware of worsening depression and increased suicidality. This was especially true for patients new to the drug or those increasing their dosage.

October 2004: FDA Orders Re-Labeling on Suicidality in Child and Adolescent Antidepressant Patients

In October 2004, the FDA issued a public health advisory. The advisor directed all antidepressant drug manufacturers to revise their product labeling. The labeling should include boxed warnings and expanded warning statements. They should alert health care providers to an increased risk of suicidality in children and adolescents. Paxil-maker GlaxoSmithKline added a black box warning to Paxil in response to the FDA advisory.

Hiring an Attorney for Your Paxil Claim

If you suffer serious health issues after using this drug, an experienced attorney can explain your legal rights. Filing a lawsuit against a pharmaceutical company is complicated and challenging, and a lawyer can advise whether your claim is worth pursuing. If so, they will advocate for you throughout the legal process and fight for fair compensation for your injuries.

FindLaw’s directory of product liability attorneys can connect you with qualified legal help in your area. Select your state or city to review contact and ratings information for local experts. Your search results will also link you to additional details about the attorneys’ experience with dangerous drug cases. Many law offices offer free case evaluations.