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Issues with Paxil

Today will officially end summer and mark the first day of fall in 2011. While many welcome the return to routine and cool relief to summer’s blazing temperatures, there are millions of Americans who suffer from a seasonal affective disorder that is said to be triggered by reduced exposure to sunlight and warmth in the fall and winter seasons.  Some of the most common symptoms of the disorder include increased fatigue, weight gain, and insomnia.  In more severe cases, symptoms can be much more debilitating including extreme irritability, crying spells, and even thoughts of suicide.  In these cases, medical treatment is recommended and antidepressant drugs are commonly prescribed. As the stress of day to day life begins to grow in American society, so does the demand for these mood-altering drugs which are believed to balance the serotonin levels in a person’s brain and alleviate feelings of depression. But while these prescriptions can seem like a quick fix to cure the summer blues, there are more serious ramifications that go along with them especially for women who are expecting.

One antidepressant in particular, Paxil, is frequently prescribed for those battling with all kinds of depression including seasonal affective disorder (SAD).  With a staggering 25% of the population suffering from one or more symptoms related to depression, it is no wonder that antidepressants remain one of the top selling drugs in the country with over 27 million people taking them nationwide according to an article published in USA Today.  Paxil is among the top selling antidepressants, belonging to a group of drugs called selective serotonin reuptake inhibitors (SSRIs). It was introduced to the market in 1992 by the pharmaceutical manufacturer GlaxoSmithKline and in its generic form is called paroxetine. As more people, particularly woman dealing with depression during pregnancy, began taking Paxil and studies progressed on the drug it was also found to be a teratogen, or any drug or substance that has the capability to interfere with the development of a fetus. Studies showed that the women taking Paxil during the first trimester of their pregnancy were about one and a half to two times as likely to have a baby with a heart defect compared with women who took other antidepressants or women in the general population. These defects included atrial and ventricular septal defects, or holes in the walls of the chamber of the heart, and at times required immediate surgery for the newborns affected by these conditions. Congenital heart defects in infants are not uncommon, affecting 1% of all newborns; however, in mothers who were taking Paxil during their pregnancy that statistic rises to 6%.

The Federal Drug Administration began their own investigation into the link between congenital heart defects in infants and Paxil, and in 2006 released this statement:

A recently published case-control study has shown that infants born to mothers who took selective serotonin reuptake inhibitors (SSRIs) after the 20th week of pregnancy were 6 times more likely to have persistent pulmonary hypertension (PPHN) than infants born to mothers who did not take antidepressants during pregnancy (see SSRI drug names at the bottom of this sheet). The background risk of a woman giving birth to an infant affected by PPHN in the general population is estimated to be about 1 to 2 infants per 1000 live births. Neonatal PPHN is associated with significant morbidity and mortality.
 
After releasing this statement, the FDA raising the pregnancy warning for Paxil from a category C to a category D, indicating that taking this pill during pregnancy has serious potential to damage a fetus. Healthcare physician are advised to take serious precaution when treating a pregnant women with Paxil, and/or if they have a patient who becomes pregnant while taking it.

There are many factors that can lead a woman to depression, whether it is the changing of seasons or dealing with a pregnancy. Whether a woman becomes pregnant while taking Paxil or it is prescribed during her pregnancy, it is important to know the risks involved with taking this pill and the harmful effects it could have on their newborn. If your child was born with a congenital heart defect as a result of taking Paxil during pregnancy, contact our office for consultation and find out what we can do to help.

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