Drugs in Class Action Litigation: Paxil

Generic name: paroxetine hydrochloride (known as SSRIs-selective serotonin reuptake inhibitor)
Manufactured and marketed by: GlaxoSmithKline

Purpose: For the treatment of mental depression, obsessive compulsive disorder, post-traumatic stress disorder and panic and anxiety disorders.

Side Effects Reported

• In October of 2004, the FDA issued a public health advisory concerning antidepressants and possible links to an increase in child suicide ideation.
• The FDA ordered the manufacturers of antidepressants to include a "black box warning" on the drug labels, alerting users of the drugs of the possible link between antidepressants and child suicide.
• Paxil is included among drugs required to carry the new warning along with other popular antidepressants including Wellbutrin, Zoloft, and Prozac.
• The black box warning is the strongest warning the FDA has available to it.
• The material included in the black box warning must be incorporated on the label as well as all advertisements for the drugs.

Industry Report

The FDA has reported that preliminary findings from new studies have indicated that Paxil may cause birth defects when taken by pregnant women in their first trimester (the first three months of pregnancy). Early indications from two studies show that women who take Paxil during the first trimester of pregnancy may be approximately one and a half to two times as likely to have a baby with a heart defect, when compared to women using alternative antidepressant medications, and women in general. According to the FDA, patients taking Paxil who are pregnant or intend to get pregnant should discuss the possible effects of Paxil with their physicians.

The first lawsuit against Paxil’s manufacturer, GlaxoSmithKline, for a child born with persistent pulmonary hypertension (PPHN), a life-threatening lung condition that can cause serious permanent damage in infants who live, was filed in 2006. Other lawsuits involving babies born with heart defects were filed against GlaxoSmithKline in 2006 and 2007. In all of these cases the mothers had taken Paxil during their pregnancies.

Several Paxil lawsuits have been filed to recover damages for patients who committed suicide while taking Paxil. For example, a Paxil lawsuit was filed in California in 2005 by the grandparents of a 20-year-old man whose symptoms worsened after taking Paxil, until he committed suicide. This Paxil litigation argues that the manufacturer, GlaxoSmithKline, failed to adequately warn about the dangers of increased suicidal thoughts and behavior in patients taking Paxil.