Paxil, manufactured by GlaxoSmithKline, has been linked to serious, life-threatening birth defects.
Approved by the FDA in 1992, Paxil is used by millions of Americans for anxiety and depression. The FDA is strengthening its warning for the antidepressant Paxil because it may be associated with birth defects, specifically, congenital heart defects, Persistent Pulmonary Hypertension of the Newborn (PPHN), abdominal and cranial defects.
UPDATE: Studies Confirm Link Between Paxil and Birth Defects
January 6, 2016 — A new study has found that women who use Paxil in early pregnancy may be 23% more likely to have a baby with any type of birth defect, and twice as likely to have a baby with certain heart defects. Click here to read more.
September 17, 2015 — Fourteen years after a major study concluded that Paxil was safe for teenagers, a re-analysis of the same data has concluded that the opposite is true. Click here to read more.
July 9, 2015 — When women use Paxil just before or during the first three months of pregnancy, they may double or triple the risk of having a baby with certain birth defects, according to a new study. Click here to read more.
June 19, 2014 — The New England Journal of Medicine has published a study concluding that pregnant women who use antidepressants during the first trimester are not more likely to have a baby with a heart defect. Click here to read more.
June 13, 2014 — The Wall Street Journal reports that a lawsuit has been filed by the widow of a man who took six pills of generic Paxil and committed suicide. The plaintiff alleges that GlaxoSmithKline is not warning that Paxil can increase the risk of suicide for adults. Surprisingly, the lawsuit has survived appeal despite the fact that it involves generic Paxil. Click here to read more.
April 3, 2014 — GlaxoSmithKline, the manufacturer of Paxil (paroxetine) antidepressants, has recalled certain batches because the active ingredient may have been tainted with pharmaceutical waste since 2012. Click here to read more.
February 2013 — GSK has agreed to pay $8.5 million to settle a Paxil class action lawsuit in California alleging that GSK used “false and deceptive” tactics to promote Paxil, including failing to warn doctors about complications like addiction and severe withdrawal. Members of the class action include California adults who took Paxil between 1999 and 2003.
Paxil Class Action Lawsuit
Hundreds of lawsuits have been filed on behalf of children who were born with birth defects after they were exposed to Paxil. However, these are not part of a Paxil class action. Instead, they are individual lawsuits. In October 2009, the family of Lyam Kilker was awarded $2.5 million for his heart defects by a jury in Philadelphia. Less than a year later, GSK agreed to pay over $1 billion to resolve 800 lawsuits involving birth defects.
What is the problem with Paxil?
Paxil is used by millions of Americans to treat depression. More specifically, pregnant women have been prescribed Paxil to help with anxiety involved with their pregnancy. The fetuses of these women using Paxil or other SSRI antidepressants such as Celexa, Lexapro, Prozac, Symbyax, and Zoloft are at a greater risk of developing a birth defect.
The two most common forms of an SSRI antidepressant congenital heart defect are atrial septal defects or ventricular septal defects. Atrial septal defect (ASD) is a form of congenital heart defect that enables blood flow between the left and right atria via the interatrial septum. There is a hole in the wall between the two upper chambers of the heart that allows for this blood flow exchange. Ventricular Septal Defect (VSD) is when there is a large opening between the ventricles allowing a large amount of oxygen-rich blood from the heart’s left side through the defect on the right side. It is then pumped back into the lungs, even though it has been oxygenated. This is wasteful, since blood that’s already been to the lungs is returning there, and blood that needs to go to the lungs is being displaced. The heart, which has to pump an extra amount of blood, is overworked and may enlarge.
The results of the study have shown that babies born to mothers who took Paxil were 6 times as likely to develop Persistent Pulmonary Hypertension of the Newborn (PPHN), than babies born to mothers who did not take Paxil during pregnancy. PPHN is failure of the normal circulatory transition that occurs after birth. It is a syndrome characterized by marked pulmonary hypertension that causes hypoxemia and right-to-left extrapulmonary shunting of blood. With inadequate pulmonary perfusion, neonates develop refractory hypoxemia, respiratory distress, and acidosis.
SSRI antidepressants like Paxil may cause two separate congenital abnormalities called Omphalocele and Craniosynostosis . An omphalocele is a congenital (present at birth) abdominal wall birth defect in which the infant’s intestine or other abdominal organs stick out of the belly button (navel). In babies with an omphalocele, the intestines are covered only by a thin layer of tissue and can be easily seen. Craniosynostosis is a congenital (present at birth) defect that causes one or more sutures on a baby’s head to close earlier than normal. Sutures are connections that separate each individual skull bones. The early closing of a suture leads to an abnormally shaped head.