SSRI Warning to Pregnant Women

Up to 20 percent of women have clinical depression at some time during their lives, and in many women, depression does not improve during pregnancy. Most commonly prescribed antidepressants are known as Selective Serotonin Re-uptake Inhibitors (SSRIs).

In May 2005, researchers from the University of Pittsburgh estimated in the Journal of American Medical Association, that in any given year at least 80,000 pregnant women in US are prescribed SSRIs. And at a news conference in February 2006, Dr Sandra Kweder of the FDA, told reporters that women of reproductive age are the "biggest users of antidepressant drugs."

Unfortunately, many women continue to take SSRIs when they are pregnant and some continue taking them throughout their pregnancy, unaware of the harm these drugs can cause their baby. SSRIs have been touted as safe for many years, but troubling data is now emerging. Commonly prescribed SSRIs (selective serotonin reuptake inhibitors) include Prozac, Lexapro, Celexa, Effexor, Paxil and more.

A study at University Hospital, Denmark, reported a link between SSRIs and major congenital malformations, including cardiac malformations. The risk was increased among women who had prescriptions for SSRIs filled in the 30 days before conception through the end of the first trimester, compared with those who had no SSRI prescriptions filled during the same period.

Another study conducted by researchers in the U.S. and Denmark compared 1,054 women who took SSRIs in the first three months of pregnancy with 150,000 others not on the drug. It found that women using the Selective Serotonin Re-uptake Inhibitors (SSRIs) in the first 12 weeks of gestation - when many may not know they are pregnant - have a 40 per cent greater risk of their baby suffering malformations. Heart defects are 60 per cent more likely.

A second study of 400 cases of persistent pulmonary hypertension, which affects the circulation of newborn babies, found a fivefold increased risk linked to use of SSRIs in late pregnancy.

In England and Wales, it is believed that approximately 25,000 of the 600,000 babies born each year have been exposed to SSRIs in the womb. In response to this alarming statistic, The Medicines and Healthcare Regulatory Agency has written to all doctors and midwives in Britain alerting them to the risk and telling them to avoid prescribing paroxetine, an SSRI, to pregnant women.

Back in 2004, Health Canada warned of potential adverse effects of SSRIs, stating that "newborns may be adversely affected when pregnant women take Selective Serotonin Re-uptake Inhibitors (SSRIs) and other newer anti-depressants during the third trimester of pregnancy." The Canadian advisory was intended to increase awareness among mothers and physicians of the possible symptoms that may occur in the newborn, so that symptoms could be recognized and acted upon immediately.

Two years later, warnings are unheeded by many pregnant women in the U.S. The FDA has been slow to recognize the dangers of SSRIs and the drug manufacturers don't want to lose profits. Media coverage is minimal.

Bonnie A.,from North Carolina, took SSRIs during her entire pregnancy and didn't know of any risks until three weeks after her son died from a coronary heart defect. In New York, Sue Jordan's daughter was born with a heart defect called aortic stenosis. The doctors cannot explain the cause. "She has gone through an open heart surgery and will need many more operations, possibly a heart transplant," she says. "My daughter spent 17 days in the NICU because of PPHN and she will always have trouble breathing," says Alex Parks (not her real name pending a lawsuit), from Atlanta, Georgia.

All three women took SSRIs during their pregnancy.

Similar studies will need to be done with the other SSRIs and other types of antidepressants. We have started a study to look at the malformation rate in babies exposed to bupropion (Wellbutrin) in utero and have completed another study, which found that in utero exposure to venlafaxine (Effexor) was not associated with an excess of malformations. Studies on the neurodevelopment of children exposed to these newer antidepressants have not been done yet.

DR. GIDEON KOREN is professor of pediatrics, pharmacology, pharmacy, medicine, and medical genetics at the University of Toronto. He is also the director of the Motherisk program at the Hospital for Sick Children in Toronto, which conducts research and provides information and counseling to women and health care providers on drug therapy during pregnancy. More information is available at www.motherisk.org or by calling 416-813-6780.
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