Should Doctors or Drug Makers Be Liable for SSRI Birth Defects?

The FDA has also issued several warnings about the serious risks that SSRIs like Zoloft and Paxil can cause to a fetus in the womb of a woman taking the drug. The dilemma that is being encountered is that birth defects caused by an SSRI happen within the first trimester of pregnancy, and some women aren’t even aware that they are pregnant during this time.

When Should Doctors Warn Patients, and are Pharmaceutical Companies Liable?

At what point should doctors be warning their patients of the potential risks of taking an SSRI antidepressant while they are pregnant? If these doctors were not aware of the risks and were unable to warn their patients, should pharmaceutical companies be held liable if a woman gives birth to a child with a birth defect because she was not given full disclosure?

Introduced in 1991 by Pfizer, Zoloft belongs to the SSRI (selective serotonin reuptake inhibitors) class of drug. The main use of the drug is to treat depression and social anxiety in adults and children. As of 2011, Zoloft was one of the most-prescribed antidepressant in the United States, with close to 37 million prescriptions written. Zoloft’s rise to popularity was attributed to the fact that it was considered a medical breakthrough in 1991 due to reports of fewer side effects when compared to older antidepressants.

Pregnancy Side Effects Linked to SSRI Antidepressants

Although fewer side effects were reported in adult users, links to a higher risk for birth defects have been on the rise. Birth defects that have been associated with the use of SSRIs during pregnancy include:

• Autism Spectrum Disorder
• Cardiac Problems
• Cleft Lip
• Persistent Pulmonary Hypertension of the Newborn (PPHN)
• Skull Defects