Zoloft (sertraline hydrochloride) is manufactured by Pfizer Inc., which gained Food and Drug Administration approval to sell the drug for the treatment of major depressive disorder in 1991. In addition to being prescribed as an antidepressant, Zoloft is commonly prescribed for a number of anxiety disorders, including obsessive compulsive disorder (OCD) and posttraumatic stress disorder (PTSD). In 2007 it was the most prescribed antidepressant in the United States and selective serotonin reuptake inhibitors (SSRIs)—the class of drugs Zoloft belongs to—are the most popular antidepressants on the market.
Although sertraline has a relatively low incidence of side effects, there are dangerous health risks associated with the drug, including those related to taking Zoloft during pregnancy. The FDA places Zoloft in pregnancy Category C, a classification that means a drug’s adverse effects on fetuses are not conclusive, but that doctors should prescribe the medication only if potential benefits outweigh potential risks.
The Zoloft medication guide, however, is far less conservative in its description of Zoloft and pregnancy side effects. According to it, unborn children exposed to Zoloft during the third trimester face a number of health risks, as supported by clinical findings, including:
- Respiratory problems
- Feeding Difficulties
- Constant crying
In 2005, the FDA issued a public health advisory warning that first trimester exposure to certain antidepressants could cause congenital cardiac malformations. Zoloft pregnancy risks were not included in this advisory, but other types of SSRIs were named.
But in the following year, the FDA issued another advisory on SSRI antidepressants and birth defects which mentioned Zoloft and pregnancy risks. Cited was a 2006 study published in The New England Journal of Medicine (NEJM) that found that drugs like Zoloft increased the chances of a baby being born with persistent pulmonary hypertension (PPHN), a life-threatening condition marked by high pressure in the lungs that limits the amount of oxygen released into the bloodstream.
In 2007, another study on Zoloft and pregnancy was published by the New England Journal of Medicine. It found, “significant associations between the use of sertraline and omphalocele and septal defects.” An omphalacele birth defect occurs when the intestines or organs protrude from the belly button, while a septal defect describes is a congenital heart defect that causes the heart to work harder due to improper blood circulation. According to the NEJM study, mothers who take Zoloft during pregnancy face twice the risk of delivering a baby with a septal defect, which can be life-threatening.
As these Zoloft and pregnancy studies show, expecting mothers who take sertraline could be placing their child’s health at risk. Be sure to speak with your doctor if you are taking Zoloft and are pregnant or plan to become pregnant.
And if you were taking Zoloft and gave birth to a child with health problems, be sure to speak with the Rottenstein Law Group. The presence of a birth defect in your newborn could make you eligible for a Zoloft and pregnancy lawsuit. To find out whether you qualify for compensation from Pfizer, contact RLG by filling out this form or calling 1 (877) 471-8940.