Heart Defects Congenital Birth Defects

The Food and Drug Administration has warned pregnant women and their doctors away from the antidepressant Paxil because of an increase risk of heart defects in newborns. A strong warning has been added to the drug's label.

The FDA is advising doctors not to prescribe Paxil to women in their first three months of pregnancy or people who are planning to become pregnant, unless there are no other options, and recommends that expectant mothers who are taking or considering taking Paxil and similar antidepressants discuss with their doctors the potential risks and benefits.

Most birth defects associated with antidepressants involve holes and malformations in the chambers of the heart. The defects often heal on their own, and more severe cases can be surgically repaired. A spokeswoman for GlaxoSmithKline said that the company is studying how and why its drug might be causing these defects, adding that it remains unclear as to whether there is a cause-and-effect relationship.

The FDA asked the drug's manufacturer GlaxoSmithKline to reclassify the drug, which goes by the generic name Paroxetine, as a "Category D" drug for pregnant women. The classification means that studies in pregnant women have shown a risk to the fetus.

The advisory is based on results from two studies, which found that women who took Paxil in the first three months of pregnancy were 1½ times more likely to give birth to a child with a heart defect than women who took other antidepressants or nothing at all. The studies found that Paxil had a risk of birth defects that other common antidepressants did not.

The long-term effects of fetal exposure to antidepressants are particularly hard to determine. Research could require following children for a decade or more.

Paxil is one of the world's most popular antidepressants, taken by tens of millions of patients since the drug was approved in 1993. It is also sold in generic form as paroxetine. About 25 percent of Paxil users are women of childbearing age, between 18 and 45.

Paxil is most commonly used to treat depression but is also prescribed to treat anxiety, panic, obsessive compulsive disorder, and post traumatic stress disorder. Side effects include:

• Suicide
• Suicidal ideation
• Violence in children and teenagers
• Intense withdrawal symptoms

Two years ago, a Wyoming jury awarded $6.4 million to the family of a patient taking the pill who killed his wife, daughter and granddaughter. It is estimated that almost 17 million people worldwide have been treated with Paxil.

British health regulators have also recently issued a warning for Paxil, stating that the drug can cause suicide and violence in children and teenagers. Following their British counterparts, Irish health officials issued a warning for Paxil in Ireland and the FDA has said it will investigate the drug further.

Britain's Department of Health said the evidence provided by the drug company, from nine studies based on more than 1,000 youngsters, shows there is an increase in the rate of self harm and potentially suicidal behavior in those under 18 taking Paxil. The British regulators wrote in a statement "It has become clear that the benefits of Seroxat in children for the treatment of depressive illness do not outweigh these risks."

One study found increased numbers of babies born with birth defects to women who were taking Paxil during the first trimester of pregnancy, as compared with women on other antidepressants. Birth defects included an increased risk of heart defects, according to a letter from GlaxoSmithKline to health care professionals.

Additionally, Paxil has long been associated with difficult withdrawal side effects, leaving patients virtually addicted to the drug. Recently, The British drug agency required Glaxo to remove a statement on its patient label saying that the drug was not addictive.

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