Paxil is a medication used to treat depression, anxiety disorders and some personality disorders. Paxil is an SSRI (Selective Serotonin Reuptake Inhibitor) antidepressant. SSRI medications work by increasing the activity of the chemical serotonin in the brain. http://www.mayoclinic.com

The use of antidepressants, such as Paxil, during pregnancy has shown to be dangerous for the fetus. Although not all women who have taken Paxil during pregnancy will experience fetal malformations the risk exists. Paxil use during pregnancy has been linked by many independent studies to birth defects in newborns. These birth defects can range from heart malformations to abdomen malformations.

Studies from many reputable institutions have shown an increased risk of fetal malformation with the administration of SSRIs during pregnancy. A study at Boston University www.bu.edu found that Paxil use was associated with an increased risk of heart defects in newborns. Similarly, studies from the Harvard School of Public Health http://www.hsph.harvard.edu/ and the American College of Obstetricians and Gynecologists www.acog.org have all found that Paxil use during pregnancy can be dangerous for the fetus.

A study conducted by members of the Department of Epidemiology of the Harvard School of Public Health http://www.hsph.harvard.edu/ has found a link between SSRI (Paxil) use and gestational hypertension. The study was conducted to assess the risks of gestational hypertension and preeclampsia while using SSRIs. This study was published in the American Journal of Psychiatry http://ajp.psychiatryonline.org/.

To do this, the researchers looked at 5,731 women with non-malformed infants. These women participated in the Slone Epidemiology Center http://www.bu.edu/slone/ Birth Defects Study from 1998 to 2007. The study conducted by the Harvard School of Public Health researchers looked at the numbers of women who did and did not develop gestational hypertension and preeclampsia in both those who did and did not take SSRIs during pregnancy. Of the 5,731 women studied, 5,532 were not treated with SSRIs. The rate at which hypertension was present in the group which was not treated with SSRIs was 9.0%. Of the 199 women who were treated with SSRIs, 19.1% developed gestational hypertension. The rate of preeclampsia in women who were not treated with SSRIs was 2.4%. The rate of preeclampsia in women who were treated with SSRIs during the first trimester was 3.7% and was 15.2% for women who continued SSRI treatment beyond the first trimester.

The researchers concluded that SSRI exposure during late pregnancy might identify women who are at an increased risk of gestational hypertension and preeclampsia. Nearly every week, more information about the use of SSRIs such as Paxil during pregnancy is being discovered.

The American College of Obstetricians and Gynecologists is known as ACOG. The College www.acog.org warns of the dangers of the use of Paxil by women who are pregnant or plan on becoming pregnant. According to ACOG, the use of Paxil has the “potential risk of fetal heart defects, newborn persistent pulmonary hypertension and other adverse effects.” A further study revealed a startling statistic. According to the study, women who took Paxil during the first trimester increased the risk of cardiac malformations by one and a half times compared to women who did not receive Paxil. http://ctr.gsk.co.uk/welcome.asp

Then yet another study based on Swedish national registry data of delivery outcomes after women used SSRI antidepressants in early pregnancy reported a 2-fold increase in the risk of cardiac defects in infants exposed to paroxetine (Paxil) compared with the general population. http://74.125.155.132/search?q=cache:4IM5zoD6WGsJ:www.gsk.com/media/paroxeti

Birth defects as a result of SSRI use are not limited to heart problems. A study referred to by the Organization of Teratology Information Specialists or OTIS www.otispregnancy.org links the use of Paxil and other SSRIs to omphaloceles (malformations of the abdomen).

Work is ongoing to bring to light the effects of Paxil during pregnancy. Considering that two of our Paxil/pregnancy cases against Glaxo www.gsk.com (the manufacturer of Paxil) are pending, we hope information regarding the effects of Paxil on babies in the womb comes to light.

A second Emory University www.emory.edu psychiatrist has been reprimanded for alleged conflicts of interest between his research and the pharmaceutical company GlaxoSmithKline www.gsk.com. Zachary Stowe was the lead investigator on at least three National Institutes of Health www.nih.gov grants that involve the study of GlaxoSmithKline antidepressants. Stowe’s grants dealt specifically with the use of antidepressants by pregnant women.

A study conducted by Stowe found that Paxil was safe for breast-feeding mothers. We question this as our Paxil baby cases proceed toward trial. Paxil has been shown by studies to be a potential danger for babies in utero. Pregnant women should be interested in the studies.

In 2007, Stowe allegedly received $154,000.00 from Glaxo and in the first 10 months of 2008, he allegedly received another $99,300.00. It appears GlaxoSmithKline has gone to great lengths to influence studies about Paxil.

Recent news reveals that a medical professor at Emory University in Atlanta www.emory.edu allegedly may have been involved in misleading the National Institutes of Health regarding consulting work done for pharmaceutical companies. The professor was the primary investigator in a study funded by the National Institutes of Health www.nih.gov concerning the use of GlaxoSmithKline drugs.

According to an investigation conducted by Emory, Dr. Nemeroff allegedly did not report $800,000 he received from GlaxoSmithKline www.gsk.com. Dr. Nemeroff apparently claimed he did not know he had to report payments for general talks on medicine. Dr. Nemeroff reportedly played a large role in a GlaxoSmithKline program to “to influence clinicians . . . on the benefits of Paxil versus competitors.” The program was also created to “help build Paxil advocacy.”

What does all of this mean to a mother who took Paxil while pregnant? If the facts are as alleged, it means there is a conflict of interest between GlaxoSmithKline and the information Dr. Nemeroff reported to the National Institutes of Health. In other words, GlaxoSmithKline allegedly may be paying Dr. Nemeroff in a round about way so that he will say good things about its drug. If so, the National Institutes of Health and thus the consumer may receive biased information on Paxil.

Considering that there are lawsuits pending against Glaxo, including ours, for mothers and babies, we would hope that any conflicts of interest involving Glaxo and the medical community are brought to light.