What is Paxil?
Paxil went on the market in December 1992. Following Prozac and Zoloft, it was the third selective serotonin reuptake inhibitor (SSRI) designed to treat depression. Made and sold by GlaxoSmithKline, it has become one of the most-prescribed drugs of its kind.

In 2002, a decade after its market debut, Paxil’s sales had risen to $3.2 billion per year.

Paxil birth defects
A recent study of a group of 958 women found that 4 of every 100 babies whose mothers took Paxil were born with birth defects. About 2 in 100 babies whose mothers took Paxil in early pregnancy had heart defects.

The babies born with these Paxil side effects mainly had heart defects, such as a hole in the heart. Others had cleft lips or palates and problems with the digestive system. Again, surgery is frequently needed for babies with these birth defects.

In September 2005, GSK issued a Paxil warning letter about the drug’s risks of causing congenital heart defects.

Paxil and suicide
It is now generally recognized that SSRIs can lead to severe inner restlessness, which in turn is associated with suicidal thoughts and behavior. Some of the Paxil suicides have taken place when people were trying to stop using the drug.

The FDA has compelled GlaxoSmithKline to add a “black-box” Paxil warning with information describing the increased risk of suicidality in children and adolescents. In May 2006, GSK and the FDA announced labeling changes pertaining to younger adults.

Paxil lawsuits
In October 2006, GSK agreed to pay $63.8 million to resolve a Paxil class action suit over claims it promoted the drug for use by children, even as it withheld unflattering information about the effectiveness and side effects of Paxil.

In the summer of 2006, a couple filed a Paxil lawsuit against GSK, alleging that the mother’s use of Paxil during pregnancy had caused their infant to be born with heart defects, requiring multiple surgeries and implantation of a pacemaker. The number of Paxil lawsuits has only grown since then. Some people are clamoring for a Paxil recall, but it has not happened yet.

If you have suffered Paxil side effects, or if your child has Paxil birth defects, call Sam Levine toll-free at (888) 404-LAWYER or fill out a free online contact form.