Dangerous Drugs, Medicines and Medical Devices PAXIL

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Heart Birth Defects

The FDA issued a Public Health Advisory for Paxil on December 8, 2005 based on U.S. and Swedish studies showing that exposure to Paxil in the first trimester of pregnancy may be associated with an increased risk of heart birth defects. 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 type of congenital malformations.

Lung Birth Defects

Persistent pulmonary hypertension (PPHN) is a serious and life-threatening lung condition that occurs soon after birth of the newborn. Babies with PPHN have high pressure in their lung blood vessels and are not able to get enough oxygen into their bloodstream. About 1 to 2 babies per 1000 babies born in the U.S. develop PPHN shortly after birth, and often they need intensive medical care.

On July 19, 2006 the FDA issued another Public Health Advisory for Celexa (citalopram), Fluvoxamine, Lexapro (escitalopram), Paxil (paroxetine), Prozac (fluoxetine, Symbyax (olanzapine and fluoxetine) and Zoloft (sertraline) based on a study that suggests there may be additional risks of SSRI medications during pregnancy. In this study PPHN was six times more common in babies whose mothers took an SSRI antidepressant after the 20th week of the pregnancy compared to babies whose mothers did not take an antidepressant.

Abdominal Birth Defects

GSK - GlaxoSmithKline, maker of Paxil, sent a letter to doctors and healthcare professionals in September, 2005 advising them of a Paxil label change that, according to data obtained from the National Birth Defects Prevention Study of infants, women who took an SSRI-antidepressant were more likely than those who were not exposed to have an infant with omphalocele (an abnormality in newborns in which the infant's intestine or other abdominal organs protrude from the navel. The strongest effect was reported to be with Paxil (paroxetine) which accounted for 36% of all SSRI exposures.

Cranial Birth Defects

GSK - GlaxoSmithKline included in the September, 2005 "Dear Doctor" letter that the authors of the above study also found an association of exposure to any SSRI-antidepressant and giving birth to an infant with craniosynostosis (a congenital defect-present at birth. The connections between sutures-skull bones, prematurely close during the first year of life, which causes an abnormally shaped skull.)

Recent studies have raised concerns that Paxil may cause cardiac (heart), pulmonary (lung) and other birth defects in infants whose mothers took Paxil during pregnancy. Information developed in recent studies reviewed by the FDA showed that women who took Paxil during pregnancy were one and a half to two times as likely to have a baby with a heart defect compared with women who took other antidepressants or women who were not taking this type of medication at all. If you or a loved one took Paxil during pregnancy and your baby was born with a heart defect, you should contact us immediately; we may be able to help you obtain compensation for your child's injuries.

Side Effects associated with Paxil include, but are not limited to the following:

• Heart Birth Defects (Atrial or Ventricular Septal Defects, Murmurs, etc)
• Lung Birth Defects (Persistent Pulmonary Hypertension)
• Craniosynostosis (resulting in an abnormally shaped head)
• Abdominal Birth Defects (Omphalocele)
• Cranial Birth Defects (Craniosynostosis)

What is Paxil?

Paxil (paroxetine hydrochloride) is an antidepressant medication that is part of a family of drugs called selective serotonin re-uptake inhibitors (SSRIs). Paxil is sold as Seroxat outside of the United States and as Paxil (paroxetine HCl) in the United States.

Paxil is currently approved by the Food and Drug Administration (FDA) for the treatment of major depressive disorder, generalized anxiety disorder (GAD), social anxiety disorder, panic disorder, obsessive-compulsive disorder (OCD) and posttraumatic stress disorder (PTSD) in adults.

Paxil is used to treat:

• Depression
• Panic disorder
• Social anxiety disorder (SAD)
• Obsessive-compulsive disorder (OCD)
• Posttraumatic stress disorder (PTSD)
• Generalized anxiety disorder (GAD)
• Premenstrual dysphoric disorder (PMDD)

Who Should Not Take Paxil?

Never take Paxil if you are taking another drug used to treat depression, called a Monoamine Oxidase Inhibitor (MAOI), or if you have stopped taking an MAOI in the last 14 days. Taking Paxil close in time to an MAOI can result in serious, sometimes fatal reactions including: