Paxil Lawsuit Lawyer –
Please note: Our law firm no longer accepts Paxil cases.
Paxil, a Selective Serotonin Reuptake Inhibitor (SSRI), has been linked to severe birth defects. Taken during pregnancy, the anti-depressant may increase the birth defect risks of Persistent Pulmonary Hypertension (PPHN), as well as heart, lung, abdominal, cranial and/or facial defects, clubfoot and other birth defects.
Other Paxil Problems
Paxil can also cause significant weight gain in adults. For children, adolescents and young adults, the drug has been shown to increase the risk of suicidal thoughts in short-term, placebo-balanced studies of major depressive disorder (MDD) and other psychiatric disorders.
Paxil Recall Information
Paxil remains on the market despite its increasing the risk of suicide and despite evidence that suggests it raises the risks of serious birth defects when taken by women during the first trimester of pregnancy and/or during the last half of pregnancy. If Paxil is recalled, we will publish that information here on our web site, so please stay tuned.
FDA Warnings for Paxil
The FDA issued two health advisories regarding Paxil in July 2006. The agency issued a safety alert stating Paxil can increase the risk of persistent pulmonary hypertension (PPHN), a serious, life-threatening lung condition that occurs soon after birth. In Dec. 2005, the agency issued a public health advisory regarding Paxil based upon two separate studies that linked SSRI’s (such as Paxil) with birth defects. The FDA has now moved Paxil to a category D drug, up from its previous category C classification, which means it has been shown to raise the risk of causing harm to a developing fetus.
In September 2005, Paxil creator GlaxoSmithKline sent a “Dear Doctor” letter that notified physicians and other health care professionals of a Paxil label change. The revised label announced that women who took SSRIs were more likely to give birth to an infant with omphalocele, an abnormality in which the infant’s intestine or other abdominal organs protrude from the navel. The “Dear Doctor” letter additionally indicated that there was an association of exposure to SSRIs and craniosynostosis, a congenital defect in which the connections between sutures/skull bones prematurely close during the first year of life, causing an abnormally shaped skull.
What is Paxil?
Paxil is a medication used to treat depression and other anxiety disorders, including major depressive disorder (MDD), obsessive-compulsive disorder (OCD), panic disorder, post-traumatic stress disorder (PTSD), social anxiety disorder and anxiety disorder.
- goes by the generic name paroxetine™
- contains the active ingredient paroxetine hydrochloride
- was originally approved Dec. 29, 1992
- is manufactured by GlaxoSmithKline
- has not been approved by the FDA for anyone under 18 years of age
Off –label Uses of Paxil
Despite severe side effects related to the use of Paxil, some users take the drug for —
- Bipolar Disorder
- Diabetic neuropathy
- Irritable bowel syndromed
- Premature ejaculation
- Pathological gambling
Paxil Side Effects
While Paxil may be effective for its approved uses, side effects associated with the drug are often severe and potentially life threatening. They include:
- Birth Defects
- Congenital Heart Defects
- Persistent Pulmonary Hypertension of the Newborn (PPHN Depression)
- Cranial Birth Defects
- Cleft Palate/Hare Lip
- Weight gain
- See other Paxil side effects here
FDA Alerts for Paxil
The FDA in July 2006 issued two alerts regarding Paxil . The first concerned a study showing that women who took SSRIs while pregnant stood a greater chance of giving birth to babies with Persistent Pulmonary Hypertension (PPHN). The second warned that Serotonin Syndrome, a life-threatening condition, can occur when SSRIs (such as Paxil) are taken simultaneously with meds used for the treatment of migraines known as 5-hydrosytryptamine receptor agonists (triptans). The FDA has also worked with Pfizer, the makers of Paxil to better assess the dangers of suicidal thoughts in children and adolescents taking Paxil. A black box warning has been added to Paxil to warn of suicidal thoughts that may occur with ingestion of the drug.
Paxil Maker fined $3 Billion for Misbranding, Fraud
Paxil maker GlaxoSmithKline (GSK) was fined $3 billion by the U.S. Justice Dept. in 2012 for unlawfully promoting Paxil for depression in minors. The DOJ alledged that, “among other things, GSK participated in preparing, publishing and distributing a misleading medical journal article that misreported that a clinical trial of Paxil demonstrated efficacy in the treatment of depression in patients under age 18, when the study failed to demonstrate efficacy. . . GSK agreed to plead guilty to misbranding Paxil in that its labeling was false and misleading regarding the use of Paxil for patients under 18.”