Women who take a common antidepressant during pregnancy are not exposing their babies to an increased risk of congenital abnormalities, a new study suggests.
The finding contradicts a warning issued by the US Food and Drug Administration in October 2005. That stated that exposure to paroxetine, also known as Seroxat, during the first three months of pregnancy could increase the risk of major congenital abnormalities, particularly cardiovascular problems.
The warning was issued on the basis of unpublished data from the drug鈥檚 manufacturer, GlaxoSmithKline, and is thought to have led some women who became pregnant while taking the drug to terminate their pregnancies.
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Wolfgang Paulus at the Institute of Reproductive Toxicology in Ulm, Germany, looked at the pregnancy outcomes of 119 women who took paroxetine during the first trimester of pregnancy and compared them to 645 women who had not been exposed to the drug.
鈥淲e found that the rate of congenital abnormalities was not increased after using paroxetine in early pregnancy,鈥� says Paulus.
鈥淪erious ramifications鈥�
Three abnormalities were reported after exposure to paroxetine: club feet after exposure throughout pregnancy; a large port wine mark after exposure up to the seventh week; and spastic torticollis (painful spasms of the neck muscles) after exposure during the first twelve weeks.
However a similar rate of abnormalities was also seen in the non-paroxetine group.
鈥淔ailure to treat depression during pregnancy can have serious ramifications for both mother and child,鈥� says Paulus, who also found that the number of women who decided to terminate their pregnancies was higher in the paroxetine group, probably partly due to their depression.
鈥淲omen and their doctors should discuss this information and make an informed decision whether or not to continue with paroxetine during pregnancy,鈥� he says.
The research was presented at the European Society of Human Reproduction and Embryology (ESHRE) conference in Prague, Czech Republic, on Monday.
