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Paxil warning: Baby at Risk

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Pregnant women must carefully consider whether or not to take Paxil.

Studies published in the last year examining the effects of antidepressants on both pregnant women and their infants have produced some alarming results. One finding shows risks to women who stop taking their antidepressants while pregnant. On the other hand, taking antidepressants such as Paxil during a pregnancy can expose a fetus to potentially fatal birth defects. Although the Food and Drug Administration will not say whether or not women who are pregnant should take antidepressants, the organization is updating its information based these studies.

One study, published in the Journal of the American Association (Feb. 1, 2006) found that women who stopped taking antidepressant medication are five times more likely to suffer a relapsed depression when compared with women who continued taking their medication. It should be noted that some of the authors of this study are financially tied to large pharmaceutical companies, putting the results of the study in doubt.

However, three other studies found that infants who were exposed to Paxil while in the womb are more likely to have birth defects. Results from the first studies, conducted in Sweden and the United States, showed an increased risk of heart defects in babies whose mothers took Paxil during their first trimester. This increase was one and a half to two times greater than for mothers who did not take Paxil. The severity of the defect ranged from minor (the problem corrected itself with no treatment) to severe (required surgery).

Based on these studies, the FDA advised in December 2005, that women who are pregnant or who are considering becoming pregnant and are on Paxil should talk to their doctors and possibly switch to another antidepressant. According to a press release from the FDA, sent out December 8, 2005, the FDA "is advising health care professionals not to prescribe Paxil to women who are in the first three months of pregnancy or are planning pregnancy, unless other treatment options are not appropriate."

Yet another study, published by the New England Journal of Medicine (Feb 9, 2006) found that taking antidepressants, including Paxil, after 20 weeks of pregnancy increases the risk of the baby being born with persistent pulmonary hypertension (PPHN). PPHN is a potentially fatal lung condition that occurs shortly after birth. Babies with PPHN are not able to get enough oxygen in their bloodstream because of high pressure in their lung blood vessels.

According to the authors of this study, the risk of PPHN is six times greater in women who take an SSRI antidepressant after the 20th week pregnancy. In women who do not take SSRIs, the rate of PPHN is one or two per 1000 live births. A statement on the FDA's website states, "Neonatal PPHN is associated with significant morbidity and mortality."

The recent concern about PPHN is in addition to previous reports that late-term exposure to SSRIs can result in infants experiencing irritability, difficulty feeding, and difficulty breathing.

In September, 2005, the labeling for Paxil was changed to include warnings that taking Paxil in the first trimester is associated with an increased risk of heart-related birth defects. After reviewing the results of the latest studies, the FDA has asked sponsor companies of the SSRIs to add a label warning about the possible risks associated with taking those drugs during pregnancy.

Based on these studies, the FDA has advised women who are pregnant or thinking about becoming pregnant to speak to their doctors before taking themselves off the medications. According to the FDA, any pregnant women who stop taking their SSRIs should be closely monitored in case their depression returns.

In the meantime, the FDA is looking for more information about the risks of PPHN in infants whose mothers took SSRIs during pregnancy.

The antidepressants in question are selective serotonin reuptake inhibitors (SSRIs). They include drugs such as Paxil, Celexa, and Proxac.

Paxil Birth Defects Legal Help

If you took Paxil during pregnancy, and your baby was born with PPHN, please contact a lawyer involved in a possible [Paxil Birth Defects Lawsuit] to review your case at no cost or obligation.
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