Sertraline, also known as sertraline hydrochloride (C17H17Cl2N), is a psychiatric drug commonly prescribed for depression, obsessive-compulsive disorder, and anxiety disorders. Recent studies indicate a connection between sertraline and birth defects. Sertraline use during pregnancy has been linked to an increased risk of birth defects in the heart, abdomen, or rectum, as well as problems with limb formation. The increased risk is small in absolute terms and pregnancy is not considered an absolute contraindication for taking sertraline, but the US Food and Drug Administration (FDA) advises doctors to use caution when prescribing it and do so only if the benefits are enough to outweigh the increased risk. Medical studies of the connection between sertraline and birth defects are are still fairly limited at this point, and further research is ongoing.
Among the most serious potential birth defects associated with sertraline are septal defects, or holes in the wall dividing the heart's left and right sides. This causes problems with blood flow and can result in breathlessness, pulmonary hypertension, and failure to thrive. In severe cases, it can eventually result in cyanosis or heart failure. Many septal defects heal on their own, but in some cases surgery is necessary to correct the problem.
Sertraline is associated with an elevated risk of omphalocele, a birth defect in the abdominal wall that causes some of the abdominal organs to be located outside of the abdomen rather than inside. The organs are contained within an extended pouch of the peritoneum, the membrane that lines the inside of the abdomen, but are outside of the muscles that form the abdominal wall. This can vary in degree, from only a few coils of the intestine extending outside the abdominal wall to extreme cases in which the intestines, liver, and other abdominal organs are entirely outside of the abdomen. Omphalocele is usually correctable by surgery, though severe cases can require a series of reconstructive operations over a period of weeks, months, or in extreme cases years.
Another area where there is a connection between sertraline and birth defects is in the arms and legs, since sertraline use is linked to an increased risk of limb reduction defects. These are birth defects caused by improper development of the fetus' limbs in the uterus. As a result, one or more limbs in a person with this defect will be abnormally small or missing entirely.
There is also an association between sertraline and birth defects of the lower digestive tract. It is linked to an increased risk of a condition called anal atresia or imperforate anus. In one form of anal atresia the anus is too narrow or in some cases completely missing, making surgical intervention necessary so that the child is able to eliminate wastes. It can also create a fistula, or abnormal connection, between the rectum, urinary tract, or vagina, and in extreme cases cause them to fuse into a single passage called a persistent cloaca.