Lawsuits Claim SSRIs Can Cause Severe Birth Defects

Millions of patients take selective serotonin reuptake inhibitors (SSRIs) for depression, anxiety and other disorders. One out of 10 people in the United States use antidepressants, making them one of the most widely prescribed medications according to a 2011 National Center for Health Statistics report.

In our news video, Editorial Director Betsy Kim interviews attorney Harris Pogust, a partner at Pogust Millrood& Milrood in Conshohocken, Penn. He claims patients on SSRIs such as Celexa, Prozac, Paxil, Zoloft and others face serious health risks. For more than a decade, his firm has represented plaintiffs in mass tort claims against drug makers.

Highly publicized lawsuits have blamed SSRIs for children’s suicides and patient addictions.

Now, Pogust’s most active cases involve women who took anti-depressants during the first trimester of their pregnancies. They assert the drugs damaged their fetuses, resulting in children born with skull malformations, heart defects, limb defects like clubbed feet, autism and various other defects.

Pfizer, which manufactures Zoloft, responded to regarding these cases:

“Millions of patients and their prescribers have chosen Zoloft for more than 20 years for the treatment of depression and other psychiatric conditions. They know best when the patient’s depression is being treated effectively and their continuing choice of Zoloft (or its generic form sertraline) to treat this common, but serious and potentially debilitating illness, is powerful confirmation of its safety and efficacy.

“Zoloft was first approved by the FDA in 1991 based on the agency’s review of the efficacy and safety data from more than 20 clinical studies involving more than 5,000 patients. There is extensive science supporting the safety and efficacy of Zoloft and the medicine carries accurate, science-based and FDA approved information on its benefits and risks, including its use in pregnant women, to assist physicians in making appropriate, patient-specific decisions. As recently as December 2011, the FDA issued further guidance regarding the SSRI class of anti-depressants that includes Zoloft, advising health care professionals ‘not to alter their current clinical practice of treating depression during pregnancy.’ The Company stands by our medicine and we intend to vigorously defend it.”

Pfizer spokesman Steve Danehy indicated that the Centers for Disease Control noted 3 percent of the 4 million annual live births in the United States have some type of birth defect. About 1 percent of live birth have some type of heart defect. This had been the statistic before SSRIs existed and has not changed since the introduction of SSRIs to the market two decades ago.

Danehy referenced a CDC statement that most birth defects are thought to be caused by a complex mix of factors, which include genes, behaviors and the environment and that for some birth defects the cause is known but for others, it is not. “Congenital heart defects are and long have been the most common type of birth defect in the U.S., affecting about 40,000 newborns each year. The vast majority of these children are born to mothers who never used Zoloft or any other antidepressant medication. Similarly, the vast majority of mothers who are treated with Zoloft during their pregnancies give birth to children with no congenital abnormalities whatsoever,” he wrote.

Pogust acknowledges the percentages of the birth defects with pregnant women using SSRIs may be small. However, he emphasizes the consequences can be severe and irreversible. He says Pfizer’s studies show the risks and people should have the right to make informed decisions. Both Pfizer and Pogust advise women to consult their doctors with questions about SSRIs.

Multidistrict litigation consolidating more than 250 Zoloft cases against Pfizer is currently before a judge in Philadelphia.