Jon Gelman is investigating cases involving Paxil users who have a child who suffered birth malformations after being exposed to Paxil within any trimester of pregnancy. Paxil and Paxil CR® are antidepressants manufactured by the pharmaceutical company GlaxoSmithKline.
· The following injuries or symptoms in infants have been associated with the prenatal use of Paxil:
- · cardiovascular malformations
- · club foot
- · congenital malformations
- · craniosynostosis
- · limb reduction
- · neural tube defects
- · omphalocele, a birth defect in which variable abdominal contents remain outside of the abdomen
- · severe withdrawal symptoms related to late stage pregnancy exposure
If your child or the child of someone you know may have experienced any of the above symptoms, contact attorney Jon Gelman by or email call +1 973.595.0319.
Drug History and Serious Adverse Reactions
Paxil and Paxil CR® (controlled release) are selective serotonin reuptake inhibitors (SSRIs). Originally approved by the FDA in December 1992, Paxil is an antidepressant prescribed for major depressive disorder, social anxiety disorder, generalized anxiety and post-traumatic stress. Paxil is also used for the treatment of patients with obsessive compulsive disorder. Paxil CR®, approved by the FDA in February 1999, is indicated for major depressive social anxiety, premenstrual dysphoria, and panic disorder, with or without agoraphobia.
On December 8, 2005, the FDA issued a Public Health Advisory alerting doctors and patients of study results that linked Paxil use during the first trimester of pregnancy with an increased risk for congenital malformations, particularly cardiac malformations. The manufacturer added new data and recommendations to the prescribing information's warnings at the FDA's request.
The FDA's conclusions and changes in prescribing information are based on its preliminary analyses of two recent unpublished epidemiology studies.
In a study using Swedish national registry data, women who received paroxetine in early pregnancy had an approximately 2-fold increased risk for having an infant with a cardiac defect compared to the entire national registry population (the risk of a cardiac defect was about 2% in paroxetine-exposed infants vs. 1% among all registry infants).
In a separate study using a United States insurance claims database, infants of women who received paroxetine in the first trimester had a 1.5-fold increased risk for cardiac malformations and a 1.8-fold increased risk for congenital malformations overall compared to infants of women who received other antidepressants in the first trimester. The risk of a cardiac defect was about 1.5% in paroxetine-exposed infants vs. 1% among infants exposed to other antidepressants.
Most of the cardiac defects observed in these studies were atrial or ventricular septal defects, conditions in which the wall between the right and left sides of the heart is not completely developed. In general, septal defects are one of the most common types of congenital malformations. They range from those that are symptomatic and may require surgery to those that are asymptomatic and may resolve on their own. It is of note that the data in these studies was limited to first trimester exposures only, and there is currently no data to address whether this or any other risk extends to later periods of pregnancy.
GlaxoSmithKline, at the FDA's suggestion, changed the label to warn of these malformations. The FDA also stated that physicians should encourage discontinuation of Paxil in pregnant patients.
In addition, the FDA issued an alert to healthcare providers in July 2006 after the results from a study showed that infants born to mothers who took SSRIs during pregnancy were six times more likely to have persistent pulmonary hypertension (PPHN) than those whose mothers did not. Infants born with PPHN suffer from abnormal blood flow through their heart and lungs, which hinders oxygen delivery to the body. PPHN is a potentially life-threatening illness.
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