HEART AND LUNG DEFECTS AND PAXIL

Paxil, an anti-depressant can cause serious birth defects including heart defects and lung defects such as Persistent Pulmonary Hypertension of the Newborn (PPHN).

HEART DEFECTS

The Food and Drug Administration is alerting health care professionals and patients about early results of new studies for Paxil (paroxetine) suggesting that the drug increases the risk for birth defects, particularly heart defects, when women take it during the first three months of pregnancy.  Paxil is approved for the treatment of depression and several other psychiatric disorders. 

FDA is advising patients that this drug should usually not be taken during pregnancy, but for some women who have already been taking Paxil, the benefits of continuing may be greater than the potential risk to the fetus.  Women taking Paxil who are pregnant or plan to become pregnant should talk to their physicians about the potential risks of taking the drug during pregnancy.  Women taking Paxil should not stop taking it without first talking with their physician.

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. Most of the heart defects reported in these studies were atrial and ventricular septal defects (holes in the walls of the chambers of the heart). In general, these types of defects range in severity from those that are minor and may resolve without treatment to those that cause serious symptoms and may need to be repaired surgically.

FDA has asked the manufacturer, Glaxo Smith Kline (GSK), to change the pregnancy category from C to D, a stronger warning. Category D means that studies in pregnant women (controlled or observational) have demonstrated a risk to the fetus. However, the benefits of therapy may outweigh the potential risks to the fetus.

Based on results of the preliminary data, GSK updated the drug's labeling in September 2005 to add data from one study. As additional data have become available, the label has now been changed to reflect the latest data from the two studies and to change the pregnancy category.

LUNG DEFECTS

According to a study released February 8, 2006, women who take Paxil, Zoloft, and other antidepressants late in their pregnancies are at an increased risk of delivering babies with a serious lung condition called persistent or primary pulmonary hypertension.

While this condition is commonly called primary pulmonary hypertension (PPH) in adults, the condition is given the name persistent pulmonary hypertension of the newborn (PPHN) when it affects infants. The term “persistent” is applied because it is common for infants to be born with high pressure in the lungs. Typically, this high pressure decreases in the first hours and days of life. Infants whose circulation systems are unable to adapt to breathing outside the womb have what is called persistent pulmonary hypertension of the newborn.

About one to two infants in the general population are born with primary pulmonary hypertension. Of these infants, ten to twenty percent will die. According to researchers, the risk of a newborn developing PPHN is six times greater for women who used an SSRI antidepressant during the third trimester, compared to those in the general population. While this risk appears to be rare, this possible antidepressant drug side effect may be significant.

While the recent study gave no clear indication that women should NOT take Paxil, Prozac, Celexa, or Zoloft during pregnancy, the New England Journal of Medicine study prompted significant concern within the FDA. The federal agency hastily called a news conference to address the results. According to an FDA spokesperson, “This appears to be a well-conducted study and we find the results to be very concerning.”

Researchers at the University of California, including the lead author of the antidepressants study, Christina Chambers, pregnant women who suffer from depression or other psychological conditions need to speak with their doctors to determine the best and safest course of treatment.

This study was published following an number of others warning of antidepressant drug side effects. A small study published just two days before in the Archives of Pediatrics and Adolescent Medicine found that newborns born to women taking SSRIs were at an increased risk of experiencing withdrawal symptoms from the drugs. A September 2005 study showed that taking Paxil in the first trimester increased the risk of birth defects. The use of SSRIs during pregnancy has also been associated with a 20 to 30 percent increased risk of “neonatal complications” which can range from jitters to breathing problems.

If you are concerned about the link between antidepressant medications and heart and lung defects, you may wish to discuss the risks and benefits of treatment with your trusted health care professional. If your child have developed a heart or lung defect, please contact us so help protect your legal interests.

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