The obstetric practice committee of the American College of Obstetricians and Gynecologists said pregnant women should not take Paxil -- a member of a class of antidepressants known as SSRIs (selective serotonin reuptake inhibitors) -- because two previous studies found that the drug posed up to double the risk of heart defects in fetuses.
Nearly a year ago, the U.S. Food and Drug Administration (FDA) and GlaxoSmithKline -- which makes Paxil -- changed the warnings on the drug to include the results of the studies. The FDA then advised pregnant women to merely switch from Paxil to another SSRI drug, such as Prozac or Zoloft.
The FDA's enhanced warning on Paxil followed the results of a review of Sweden's birth registry that found pregnant women who took Paxil were 1.5 to 2 times more likely to give birth to a baby with heart defects than women who took other SSRIs or who did not take antidepressants at all.
The most common defects caused by antidepressants were holes or other malformations in the chambers of the heart. Often the defects heal on their own, but more severe cases require surgical intervention. Glaxo said last December that it was investigating how Paxil could be causing the defects.
The obstetricians went a step further than the FDA in recommending that women avoid Paxil and reconsider using any SSRI antidepressant during pregnancy. Other physicians claim that the benefits of mothers getting treatment for their depression outweigh the risks to the fetus.
However, consumer health advocate Mike Adams calls the FDA's caution last year and the obstetricians' current opinion "after-the-fact warnings," since Paxil and other SSRIs are still being prescribed to pregnant women, often without warning of the possible harm to unborn children.
"It demonstrates yet again how patients are guinea pigs when it comes to pharmaceutical safety, and how the current drug safety testing system is entirely inadequate," Adams said.
"Plus, there's the fact that antidepressant drugs imbalance blood sugar metabolism, worsening gestational diabetes," he said. "This fact is almost never explained to expectant mothers who are prescribed such pills."
Paxil is currently one of the most popular antidepressants in the world, and roughly 25 percent of its users are women of childbearing age -- between 18 and 45.
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