FDA Warns Against Prescribing Antidepressant in Early PregnancyDec 8, 2005 | Los Angeles Times
Health officials today warned doctors about prescribing the antidepressant drug Paxil to women in the early stages of pregnancy after new tests suggested that taking the drug increases the chances of birth and heart defects in newborns.
The Food and Drug Administration advised doctors to discontinue prescribing Paxil or switch to another antidepressant for patients who are in the first three months of pregnancy or are planning to become pregnant. Women taking Paxil, which is made by Glaxo SmithKline, should not stop taking it without first talking with their physician, the agency said.
The FDA issued the warning after a second medical study found that the babies born to women taking Paxil were at higher risk of birth defects than those women who were not on the drug or taking other antidepressants. Most of the heart defects, some of which were serious enough to require surgery, were small holes in the walls of the heart chamber.
"The early results of two studies showed that women who took Paxil during the first three months of pregnancy were about one and a half to two times as likely to have a baby with a heart defect as women who received other antidepressants or women in the general population," the FDA said in a statement.
One of the studies found that the risk of heart defects in babies whose mothers were taking Paxil in the early stages of pregnancy was 2%, double the risk for the general population. The risk of heart defects in babies whose mothers had taken Paxil in the first three months of pregnancy was 1.5%, compared to 1% in babies whose mothers had taken other antidepressants, the agency said.
Glaxo SmithKline spokeswoman Gaile Renegar said the company had changed the warning labels on Paxil this week to reflect the FDA's concerns.
Doctors have written more than 100 million Paxil prescriptions for U.S. patients since the drug was introduced in 1993.