Paxil is an antidepressant medication widely used worldwide, generating more than $1 billion in annual sales. It is a Selective Serotonin Reuptake Inhibitor (SSRI) among which we find Prozac, Zoloft, Celexa or Lexapro, other commonly used antidepressants. Usually considered among the milder types of antidepressant drugs since it is believed to be non-addictive, Paxil has been on the news lately with reported cases of withdrawal symptoms and birth defects. Perhaps the most disturbing is the effects it can have on the fetus when a woman takes this prescription drug during the first 3 months of pregnancy. Because of this grave danger, the FDA approved on September 2005, a change in the label as a warning for users and physicians about the risks of congenital malformations of babies.
This warning comes from a recent study done by GlaxoSmithKline with more than 3,500 pregnant women. The study carried out was a retrospective epidemiological one, which is after the fact, looking at the effects today of a drug taken many years back. The study did not have a control group of birth defects in babies with mothers who were not taking antidepressants during early pregnancy. The results of the study showed a connection between Paxil twice as many defects at birth than other SSRIs. The most common complications seen were heart related. There were malformations caused by ventricular septal defects, the holes between the two pumping chambers of the heart. Since birth defects are not common in the U.S., it is still left to determine the exact role Paxil played in this incidence. In the mean time, there has been a change in the label of this drug, warning pregnant women.
The conclusions is still a debated issue since some data show a higher incidence of birth defects with the use of SSRIs and some other data show no correlation. Although GlaxoSmithKline has not explicitly admitted to a direct link between Paxil and birth defects, for a lack of clear evidence, the possibility of this danger is still important for many people. If you are pregnant or want to become pregnant, you should contact your doctor since there is the risk of damaging the fetus with the use of Paxil. The official website of Paxil has announced the reported complications of babies that include "difficulty breathing, turning blue, seizure, changing body temperatures, general feeding problems, some vomiting, low blood sugar levels, floppiness, stiffness, tremors, shakiness, irritability or constant crying. Tube feeding, help with breathing and longer hospitalization may be needed."
If you or anyone you know has suffered from these symptoms from the intake of Paxil during the first trimester of pregnancy, you may meet the criteria for a class action lawsuit for compensation.