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Paxil Lawsuits

Paxil is the brand name for paroxetine. It's a prescription drug doctors use to treat depression or anxiety disorders. Paxil is a selective serotonin reuptake inhibitor (SSRI). These drugs increase the amount of serotonin in the brain. Serotonin is one of the chemicals that help regulate your moods.

GlaxoSmithKline manufactures Paxil. The U.S. Food and Drug Administration (FDA) approved the drug in 1992.

Conditions Paxil Treats

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

You must tell your doctor about any drugs, including over-the-counter medications and supplements.

Paxil Health Risks

Besides common side effects, Paxil has other health complications.

The risks of using Paxil include:

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

It's important to tell your health care professional 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 health care 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 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.


Hiring an Attorney for Your Claim

If you experience severe side effects while taking Paxil, you have rights. You may have a valid product liability claim against the drug manufacturer.

Since product liability is a complex area of the law, you should contact a drug and medical device product liability attorney and schedule your free case evaluation as soon as possible.

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