Paxil, Paxil Oral Suspension, and Paxil-CR are trade names of the drug Paroxetine, which is a member of a class of drugs known as “selective serotonin reuptake inhibitors” (SSRIs). A 2005 study based on 3,500 pregnant women, linked Paxil to twice as many birth defects compared to other antidepressants when taken during the first three months of pregnancy.

The birth defects identified in the study included congenital defects, heart defects and persistent pulmonary hypertension of the newborn (PPHN), a potentially fatal disease.

If your child was born with birth defects and you were prescribed Paxil or other antidepressant drugs while pregnant, please contact our law firm to learn about your rights for no charge or obligation.

The findings about the drugs, known as atypical antipsychotics, bolster concerns about giving the medicines to patients under 18 years of age. The study’s authors urged child psychiatrists to exercise caution before deciding to prescribe, and to closely monitor patients taking the drugs.

Read the full story on the Wall Street Journal website.

The most dramatic moment for the 70 doctors and 200 spectators attending June FDA hearings about approving new psychiatric drugs for children came when two bereaved mothers approached the open mike. Liza Ortiz of Austin, Texas, told the advisory panel her 13-year-old son died of Seroquel toxicity in an ICU days after being put on the antipsychotic. “His hands twisted in ways I never thought possible,” she said.

Next was Mary Kitchens of Bandera, Texas, who described Seroquel’s lasting effects on her 13-year-old son Evan after being given the antipsychotic without her knowledge or permission by a residential treatment center.

But for Kitchens the most dramatic moment came after the hearings when she approached Dr. Robert Temple, the FDA’s director of the Office of Drug Evaluation, who had officiated on the panel. “Can I show you the stamp on these Seroquel samples that proves my son was given an unapproved drug in 2003?” she asked him, displaying the original drug packaging, which she also showed at open mike. “The panel is considering whether these drugs should be approved for children – and I can show you they’ve been marketed to kids for years!” “I’m sorry, ma’am – I can’t talk to you,” replied Temple, making a quick getaway.

As Kitchens further stated, “The committee was willing to talk ‘openly’ with reporters who quite frankly did not know what questions to ask, but a mom who traveled 1,300 miles was not allowed to ask one simple question at the press conference! The vote was already in and I was completely devastated – realizing that every child in America is going to be affected by this. That’s why I followed Dr. Temple down the hall,” she says.

You can read the full article here. The issues are complicated but clearly much work needs to be done to improve the drug approval system and ensure the safety of our nation’s youth.