The Food and Drug Administration issued a health alert on September 27, 2005, to medical professionals and that GlaxoSmithKline changed the labeling on their popular antidepressant Paxil to reflect growing concerns about birth defects. Women that took Paxil during their first three months of pregnancy were one and a half to two and a half times more like to have a baby with a serious heart defect as were women that received other antidepressants. The majority of these heart defects were atrial and ventricular septal defects such as holes in the walls of the chambers of the heart.

One of the most common side effects of Paxil use is the development of heart problems such as persistent pulmonary hypertension of the newborn (PPHN) in unborn children of women that use the drug.  This condition is characterized by the failure of the newborn’s lungs to “switch over” to breathing air after birth, which can restrict the amount of oxygen to a baby’s delicate body.  PPHN can result in a number of serious and potentially life-threatening complications such as:

• Hearing loss
• Lack of ability to take feedings; some children require feeding tubes in order to assist them in eating.
• Inadequate oxygen to the brain
• Bronchopulmonary dysplasia (Scarred, stiff lungs that restrict breathing)
• Heart failure
• Kidney failure
• Brain hemorrhage
• Seizures
• Multiple organ damage
• Death

Many experts believe that because Paxil is used to treat an imbalance of the neurotransmitter Serotonin it can have numerous adverse effects on an unborn child. In addition to the vital role Serotonin fulfills in normal brain chemistry, it also plays a critical role in fetal heart development.  Paxil is believed to cross over the umbilical chord and into the developing child, and thus many experts believe that an imbalance of Serotonin in a baby’s body can affect the way the heart functions.
In response, the FDA released a Paxil warning to physicians that the drug could lead to a dramatic increase in the number of developing fetuses with congenital heart defects.  Studies show that women who were prescribed the drug during the first trimester of pregnancy delivered babies with Paxil birth defects such as Persistant Pulmonary Hypertension in the Newborn at 1-2 times the normal rate.  Studies show that PPHN is fatal even with treatment in 10 to 20% of the infants that develop it. 
First available in 1993, Paxil became a popular antidepressant medication used by millions of people around the world to treat a number of conditions including:

• Depression
• Panic Disorder
• Obsessive-Compulsive Disorder
• Social Anxiety Disorder (SAD)
• Generalized Anxiety Disorder (GAD)
• Premenstrual Dysphoric Disorder (PDD)
• Posttraumatic Stress Disorder (PSD)

Off-label prescriptions for Paxil often include treatments for:

• Chronic Headaches
• Tingling in hands and feet due to diabetes
• Male sexual dysfunction
• Bipolar disorder

Paxil is intended for adults, but some doctors saw that the drug was effective in treating depression in children as well. Unfortunately, Paxil allegedly actually increases depression in children, and in some cases led to suicidal thoughts and actions. In fact, not only did GlaxoSmithKline know about these potential side effects, they actually advised their sales representatives to not discuss the potential for suicide with prospective doctors.

If you or someone you know was injured by Paxil, you may have a right to seek monetary damages for your pain and suffering. You must act quickly, for statute of limitation time restriction laws in your state could end your case before it has a chance to begin. Let our dedicated and experienced Paxil attorneys help you get the justice you deserve. Contact us today.