Pharmaceutical Recall

Paxil

What is Paxil?

Paxil is in a class of medications called selective serotonin reuptake inhibitors (SSRIs). Paroxetine or paroxetine hydrochloride, marketed by the drug name Paxil, was approved as a medication by the U.S. Food and Drug Administration (FDA) in 1992 as a treatment for adult depression, social anxiety disorder, panic disorder, and Premenstrual Dysphoric Disorder. The medication is manufactured and marketed by GlaxoSmithKline in the U.S. in two versions — Paxil and also in a controlled release form, Paxil CR. SSRIs help maintain a balance of serotonin levels in the brain in order to restore the brain to a normal emotional state.

 

The drug has recently come under increased scrutiny. In 2003, studies revealed that when pregnant women took Paxil, there was a 2.2 fold increase in birth defects, and in particular, heart defects. Other risks to an unborn baby can include congenital malformations, hearing loss and trouble feeding. The FDA has required label changes and has sent an advisory to doctors informing them of the increased risks for birth defects.

 

Paxil Use During Pregnancy

Since its introduction in 1992, millions of doses of the medication Paxil have been prescribed to treat depression and anxiety. More and more evidence is emerging that using Paxil or other selective serotonin reuptake inhibitors (SSRI) during pregnancy can increase the likelihood of life-threatening birth defects such as heart and lung defects.

 

Mothers who have used Paxil during pregnancy and expectant mothers taking the drug should be aware of theseÝbirth defect risks. If your child was born with a birth defect or a congenital heart condition, you should learn as much as you can about your child's condition and what might be done to correct the problem or lessen its effects.

 

Medical treatment for these conditions is very costly. An attorney at Tomblin Carnes McCormack, LLP can help explain your rights.

 

The Risks to Your Child

Using Paxil during pregnancy has been linked to at least two types of serious birth defects:

• Ventricular and/or Atrial Septal Defects —— these heart defects prevent full oxygenation of the blood by the lungs. Studies indicate that Paxil taken in early pregnancy doubles a baby's chance of being born with a heart defect. During the first several weeks of pregnancy, the baby's heart develops. It is possible a woman is not aware she is pregnant before her baby's heart is completely developed. These defects affect the chambers of the heart. In most cases the defect can be corrected by surgery. In a small number of cases, the defect can heal itself as the child grows. This medical condition is commonly called a "hole in the heart."



• Persistent Pulmonary Hypertension of the Newborn (PPHN) — Babies born with PPHN have abnormal blood flow through their heart and lungs and do not get enough oxygen to their bodies. Babies born with PPHN can be very sick and may even die. An article in the February 9, 2006 New England Journal of Medicine entitled "Selective Serotonin-Reuptake Inhibitors and Risk of Persistent Pulmonary Hypertension of the Newborn" describes a study which found an association between the maternal use of SSRIs (including Paxil) and PPHN in the offspring.

 

Paxil and Birth Defects
A 2003 GlaxoSmithKline study showed that Paxil use during pregnancy increased the risk of birth defects by 2.2 times. These serious defects involve heart malformations such as atrial and ventricular septal defects.

 

A separate study by the Swedish National Registry of 6,896 infants exposed to selective serotonin reuptake inhibitors (SSRI) anti-depressants showed that exposure to Paxil and other SSRIs in early pregnancy almost doubled the risk for fetal heart defects compared to the rest of the Registry population.

 

Using Paxil during pregnancy has been linked to other complications, including respiratory distress, hypoglycemia, jaundice, premature birth, and other health problems in the newborn.

 

How We Can Help

Tomblin Carnes McCormack, LLP attorneys will strive to obtain compensation, answers and justice for people who have suffered injury because of defective medications in appropriate cases. If you used Paxil during pregnancy and your child was born with PPHN or a birth defect, we may be able to help.

 

Your child deserves to live a life as full and as complete as possible. A Paxil claim may provide your child with a chance to live that life.

 

Protect Your Child's Health and Your Rights

If you took Paxil or Paxil CR during pregnancy and your child was born with a heart defect or other birth defect, Paxil may be the cause. To ensure that your child's condition is adequately diagnosed and addressed, speak with your doctor.

 

You should also speak with a Tomblin Carnes McCormack, LLP attorney to discuss your legal options. Tomblin Carnes McCormack, LLP helps victims of defective drugs, defective products, and other injuries caused by negligence. An attorney at our firm can explain your rights and discuss the process.

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