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Paxil® If you are seeking legal advice about a case involving Paxil, please call us toll-free at 800-394-2119. What You Should Know Paxil Linked to Birth Defects On September 27, 2005, the Food and Drug Administration (FDA) and GlaxoSmithKline notified healthcare professionals of changes to the Pregnancy/PRECAUTIONS section of the Prescribing Information for Paxil® to describe the results of a study of major congenital malformations, which are physical body or organ malformations existing at birth. If you are seeking a Tennessee Paxil attorney and have questions about a potential case involving Paxil, CLICK HERE for a free case assessment. What You Should Know: The study suggested women taking Paxil are at an increased risk of their children being born with major birth defects as compared to other antidepressants.
Paxil is a drug approved by the FDA to treat depression, generalized anxiety disorder (GAD), social anxiety disorder, panic disorder, obsessive compulsive disorder (OCD), and posttraumatic stress disorder (PTSD) (3). Paxil is a selective serotonin reuptake inhibitor (SSRI) drug which has been linked to a higher risk of suicide rates in adults taking the drug (4). On September 14, 2004, the FDA voted 15-8 to recommend SSRI drug manufacturers add a black box warning label stating that these drugs can be linked to suicidal thoughts and behavior in children and adolescents. The black box warning is the most strongly worded and serious label available. All magazine and television ads are required to include the warning. Additionally, in February of 2005, Spanish researchers reported that babies born to women who were taking SSRIs may experience neonatal withdrawal syndrome within the first few days of birth, and this association was highest in mothers who were taking Paxil (5). The FDA issued the following statement: “Healthcare professionals are advised to carefully weigh the potential risks and benefits of using paroxetine [Paxil] therapy in women during pregnancy and to discuss these findings as well as treatment alternatives with their patients (1).” What should I do: We are attorneys in Nashville, Tennessee who specialize in personal injury drug litigation. If you have a child who has birth injuries and you took Paxil, please contact us at our toll-free number of (800) 394-2119. |
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