Paxil Recent News
By Christie Nicholson, J.D. | Legally reviewed by Oni Harton, J.D. | Last reviewed January 10, 2024
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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.
Patients take Paxil for a variety of reasons. While the drug has many side effects, it has proven to be as safe as many alternative prescription drugs, such as Prozac (fluoxetine).
Doctors prescribe Paxil to help patients with several mental health disorders. These disorders include:
- Social anxiety disorder
- Panic disorder
- Obsessive-compulsive disorder
- Generalized anxiety disorder
- Major depression
- Premenstrual dysphoric disorder
- Post-traumatic stress disorder (PTSD)
- Bipolar disorder
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 will briefly discuss Paxil's side effects. It will also offer an overview of news about antidepressants and explain what to do if you've become sick after taking the drug.
Paxil's Side Effects
As with most prescription drugs, there are risks of several side effects when taking Paxil. The side effects are similar for similar generic drugs.
Many patients report discontinuation of the medication because of these side effects. The more common side effects of Paxil include:
- Suicidal thoughts
- Sexual dysfunction
- Serotonin syndrome
- Heart defects
- Cardiovascular issues
- Constipation
Many news reports over the years confirm these side effects. They have also helped educate the public about the risks of taking Paxil and other antidepressant medications. We'll discuss notable stories about Paxil in more detail below.
June 25, 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.
Jan. 22, 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.
Dec. 5, 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.
Nov. 30, 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.
Oct. 27, 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 28, 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 12, 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 30, 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.
Oct. 15, 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.
What To Do if Your Antidepressant Medication Makes You Sick
If you believe you're experiencing severe side effects from taking Paxil, talk to your doctor immediately. If your symptoms persist for over a week or two, your doctor may want to change medications.
If you suffer serious health issues after using this drug, contact a product liability attorney. They can help check your claim to see if it's worth pursuing.
Next Steps
Contact a qualified product liability attorney to make sure your rights are protected.
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