Drug Warnings: Paxil Side Effects and Risks

UPDATED: Jul 13, 2023Fact Checked

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Jeffrey Johnson

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Jeffrey Johnson is a legal writer with a focus on personal injury. He has worked on personal injury and sovereign immunity litigation in addition to experience in family, estate, and criminal law. He earned a J.D. from the University of Baltimore and has worked in legal offices and non-profits in Maryland, Texas, and North Carolina. He has also earned an MFA in screenwriting from Chapman Univer...

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UPDATED: Jul 13, 2023

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UPDATED: Jul 13, 2023Fact Checked

Paxil (generic paroxetine hydrochloride) is an antidepressant manufactured by the pharmaceutical giant GlaxoSmithKline. Paxil is approved by the FDA (Food and Drug Administration) to treat depression, anxiety, panic, obsessive-compulsive activity, and post traumatic stress in adults. It’s not approved for the treatment of children under 18, because studies have failed to prove Paxil is an effective treatment for children. Paxil is known as a SSRI (selective serotonin reuptake inhibitor) drug.

Paxil has been the focus of debates about safety and the target of several official warnings.

The FDA issued a December 2005 warning about the risks of birth defects in infants born to women who took Paxil during the first trimester of pregnancy. Paxil increased “the risk of congenital malformations, particularly cardiovascular malformations.” Paxil has been more likely to cause birth defects than other SSRIs.

In March 2006, Health Canada issued a strongly worded warning to all pregnant women to take great care in using SSRIs during pregnancy because of the risk of danger to their babies that could be life threatening. Pregnant women were advised to discuss the dangers with their health care providers.

Studies have linked Paxil in particular to cardiovascular malformations, and one study has linked all SSRIs, including Paxil, with three other malformations, two of the head and one of the abdominal wall.

A 2006 study linked SSRIs with a sometimes fatal lung condition in infants whose mothers had taken the drugs.

In March 2006, an FDA research team reviewed studies on children and suicide and concluded that SSRI use increases risks for suicidal thoughts and behavior in patients under 18. An earlier FDA Public Health Advisory warning was given in October 2003, to inform the public about possible increases in suicide and violence in children and teenagers using Paxil. A few months earlier, in June, the British drug regulatory agency had ruled that Paxil should not be prescribed for children. The FDA has not banned the use of SSRIs for children under 18, in spite of a lack of evidence that the treatment with drugs like Paxil is effective for patients in that age group. The FDA has chosen to rely on increased warnings.

Check out the following articles for more information about Paxil, filing a Paxil lawsuit and finding a Paxil attorney:

Case Studies: Paxil Side Effects and Risks

Case Study 1: Birth Defects in Infants (John’s Story)

John, a 30-year-old man, and his wife Sarah were excitedly expecting their first child. Sarah had been prescribed Paxil to manage her anxiety during pregnancy. Unfortunately, they were unaware of the potential risks associated with Paxil use. As a result, their baby boy was born with severe cardiovascular malformations, requiring immediate medical intervention.

Case Study 2: Risk to Babies and Lung Condition (Sarah’s Story)

Sarah, a 28-year-old woman, was struggling with depression during her pregnancy. Her doctor prescribed Paxil to help manage her symptoms. Little did she know that taking Paxil could pose serious risks to her unborn baby. Shortly after giving birth, her baby girl developed a life-threatening lung condition linked to the use of SSRIs during pregnancy.

Case Study 3: Suicidal Thoughts and Behavior in Children (Mark’s Story)

Mark, a 16-year-old teenager, was diagnosed with severe depression. Seeking help, his psychiatrist prescribed Paxil as part of his treatment plan. However, Mark’s mental health took a troubling turn as he began experiencing an increase in suicidal thoughts and behavior. His concerned parents discovered the FDA’s warnings about the potential risks of SSRIs in children.

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Jeffrey Johnson

Insurance Lawyer

Jeffrey Johnson is a legal writer with a focus on personal injury. He has worked on personal injury and sovereign immunity litigation in addition to experience in family, estate, and criminal law. He earned a J.D. from the University of Baltimore and has worked in legal offices and non-profits in Maryland, Texas, and North Carolina. He has also earned an MFA in screenwriting from Chapman Univer...

Insurance Lawyer

Mary Martin

Published Legal Expert

Mary Martin has been a legal writer and editor for over 20 years, responsible for ensuring that content is straightforward, correct, and helpful for the consumer. In addition, she worked on writing monthly newsletter columns for media, lawyers, and consumers. Ms. Martin also has experience with internal staff and HR operations. Mary was employed for almost 30 years by the nationwide legal publi...

Published Legal Expert

Editorial Guidelines: We are a free online resource for anyone interested in learning more about legal topics and insurance. Our goal is to be an objective, third-party resource for everything legal and insurance related. We update our site regularly, and all content is reviewed by experts.

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