Understanding Paxil Birth Defects

By: johnsonlawgroup
In December 2005, GlaxoSmithKline (GSK) posted its Paxil findings on its website regarding pregnant women taking antidepressants. In this announcement, GSK noted that it was revising its pregnancy precaution category from C to D. This revision was based on recent studies that indicated positive evidence of human fetal risk. In addition, GSK was placing this information in the WARNINGS section of the Paxil label.

The FDA then advised pregnant women to switch from Paxil to another SSRI drug, such as Prozac or Zoloft. This warning was based on the results of an analysis of Sweden's birth registry that showed 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 selective serotonin reuptake inhibitors (SSRIs) or no antidepressant at all.

Studies also showed that complications were reported for babies born to mothers who had taken antidepressants such as Paxil in the third month of pregnancy. Such complications included breathing difficulties, turning blue, seizures, changing body temperature, feeding problems, vomiting, low blood sugar, stiffness, tremor, irritability or constant crying. In other words, just like adults, newborn babies of mothers who have taken Paxil while pregnant, experience similar withdrawal symptoms. Because of this, tube feeding, help with breathing and longer hospitalization may be needed. Premature births in pregnant women exposed to SSRIs such as Paxil have also been reported.

Based on such reports obstetricians went so far as to recommend that women avoid Paxil and reconsider using any SSRI antidepressant during pregnancy. Still, other physicians maintain that the benefits of mothers getting treatment for their depression outweigh the risks to the fetus.

The most common birth defects caused by antidepressants have been found to be holes or other malformations in the chambers of the heart. Often the defects heal on their own, but more severe cases need surgical procedures. GSK is investigating how Paxil could be causing such defects.

In addition, antidepressant drugs are known to imbalance blood sugar metabolism thereby worsening gestational diabetes. However, it is doubtful that this is explained to expectant mothers who are given such drugs.

Medical professionals in women's mental health point out that it is important to aptly gauge the timing of medications prescribed for women who are pregnant. 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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