Pharmaceutical Injury: Antidepressants Linked to Serious Birth Defects
What if your doctor told you taking antidepressants while you were pregnant would be okay, and that the risks of birth defects were extremely low? The general social assumption is that our healthcare providers know best, so if your doctor prescribes you antidepressants you expect them to be a safe option. The problem is, they’re not failsafe by any means.
Despite the fact that the Food and Drug Administration (FDA) has expressed concerns surrounding the safe consumption of antidepressants during pregnancy, they continue to be prescribed to pregnant women across the country. Treating depression during pregnancy is both a common and complex challenge for the healthcare community, walking a balance beam between jeopardized fetus and maternal health.
What Birth Defects Can SSRIs Cause?
As outlined by the Mayo Clinic, FDA, and the U.S. National Library of Medicine, a specific type of antidepressants known as selective serotonin reuptake inhibitors (SSRIs) have been associated with very serious birth defects:
- A heart and lung problem called persistent pulmonary hypertension of the newborn (PPHN).
- Neonatal abstinence syndrome (NAS), in which a newborn experiences symptoms of withdrawal after being exposed to prescription drugs while in the mother’s womb.
- Congenital heart defects, which are problems with the structure of the heart.
- Abnormal muscle tone and suction.
- Seizures.
- Hyponatraemia, in which the infant’s blood has abnormally low levels of sodium, causing their cells to swell and them to experience numerous health problems.
Do the Benefits of Taking Antidepressants Outweigh the Risks?
A study of nearly 10,000 babies with birth defects and nearly 6,000 healthy infants revealed that mothers who took two different SSRIs, sertraline hydrochloride and paroxetine, were at two to three times the risk of having a baby born with a heart defect, according to U.S. Health News.
Furthermore, the FDA has issued “Black Box” warnings and a Public Health Advisory for SSRIs and their possible link with an increased risk of PPHN and NAS.
- A “Black Box” warning label is placed on medication the FDA deems to have a potential side effect or complication serious enough to warrant drawing immediate attention.
- A Public Health Advisory is a statement the FDA issues summarizing concerning information pertaining to a medication.
When Pharmaceutical Companies Hide the Dangers
What happens when information about antidepressant risks are not fully disclosed to patients?
One example was outlined in the Madison-St. Clair Record legal journal, reporting on nearly 40 lawsuits brought against Pfizer for birth defects allegedly caused by Zoloft. The article states Pfizer neglected to inform patients and doctors of the medication’s dangers, and instead attempted to boost sales by distributing materials claiming Zoloft was an exceptional drug for treating depression during pregnancy. When a pharmaceutical company fails to notify appropriate federal departments, the public, and the medical community about the risks their products pose, that is willful negligence on their part. They can be held legally accountable under a facet of law known as product liability.
Becoming Educated About Antidepressants and Your Legal Rights
The Mayo Clinic lists tricyclic antidepressants, certain SSRIs, and bupropion as generally considered “okay” to take during pregnancy and overall, the risk of birth defects is extremely low. Yet, within a few sentences they note the possibility of serious birth defects needs to be taken into consideration. How is a mother expected to decipher these contradictions?
While a mother has the responsibility to have serious discussions with her doctor and proactively conduct research on antidepressants before using them, a doctor has a legal responsibility to ensure his/her patients are aware of all the risks associated with medication, and never sugarcoat the severity of possible complications.