A Canadian judge has cleared the way for a class action lawsuit over Paxil birth defects to move forward in that country against the makers of the popular antidepressant, alleging that inadequate warnings were provide about the risks associated with use of Paxil during pregnancy.
Although GlaxoSmithKline objected to the certification of the Paxil class action, a British Columbia Supreme Court Judge ruled last week that the case may proceed.
The lawsuit was filed by Faith Gibson, who alleges that she took Paxil from 2002 through 2005, while she was pregnant. As a result of the side effects of Paxil, Gibson indicates that her daughter was born with a hole in her heart.
An estimated six million Paxil prescriptions were written in Canada for women of child-bearing age between 1993 and 2009, but it is unclear how many women would be eligible to participate in the class action lawsuit.
Paxil (paroxetine) is a selective serotonin reuptake inhibitor (SSRI) prescribed to treat depression. Approved in 1992, it has become one of the most commonly prescribed drugs in the United States, with sales of just under $1 billion in 2008.
In December 2005, the FDA issued an alert in the United States about the risk of birth defects from Paxil, after studies showed the drug could increase the risk of the heart defects when taken during the first three months of pregnancy. At that time, the agency also required GlaxoSmithKline to update the warning label in this country to include information about the pregnancy risks with Paxil.
The company has faced hundreds of Paxil lawsuits in the United States, which were brought on behalf of children who suffered various birth defects and malformations, such as persistent pulmonary hypertension in newborns (PPHN) and other health problems. The complaints alleged that Glaxo purposefully hid test results that would have revealed the risks associated with use of Paxil during pregnancy and misled doctors.
In October 2009, a Pennsylvania jury awarded the family of a three year old child $2.5 million in compensation for birth defects from Paxil, following the first trial in the country. In 2010, it was reported that GlaxoSmithKline agreed to pay more than $1 billion to settle Paxil birth defect lawsuits.