Use
of Paxil Medication During Pregnancy and Birth
Defects
Paxil is a popular medication used to treat depression, anxiety, and other conditions. It has been directly linked, when used during pregnancy, to increase risks of birth defects and development of Persistent Pulmonary Hypertension of the Newborn (“PPHN”).
PPHN is a dangerous condition that affects the heart and lungs of a newborn. The problem causes the baby’s blood flow to bypass the lungs, and as a result, oxygen does not enter the blood stream. The supply of oxygen to the heart and other organs is cut off. The loss of oxygen can seriously damage the organs, or possibly cause death. Even if the condition is detected and treated, children who suffer from it may develop long term problems such as pulmonary disorders, breathing problems, developmental delays, seizure disorders, and neurological deficits.
According to recent statistics, over 25 million prescriptions are written for Paxil – which also is known as paroxetine – each year. Of these, more than 6.3 million are written for women in the childbearing years.
In 2003, GlaxoSmithKline (“Glaxo”), which makes Paxil, sponsored a study that indicated that use of Paxil during pregnancy increased the risk of birth defects more than two fold, with the most common defect being cardiovascular abnormalities. However, through 2005, Glaxo marketed Paxil, which is a leading anti depressant, as a Pregnancy Category C drug. That rating indicated that animal studies had shown adverse effects on the fetus, but without adequate well controlled studies in humans to confirm the effects.
Glaxo did not strengthen the warning on Paxil until December 2005, when, at the request of the FDA, it changed Paxil’s rating to a Pregnancy Category D product. That changed rating means there is positive evidence of human fetal risk associated with Paxil use during pregnancy.
Medications for the treatment of anxiety, depression, and obsessive compulsive disorders are top moneymakers for pharmaceutical giants such as Glaxo. Indeed, Glaxo has reported more than one billion dollars in annual sales of Paxil.
Glaxo continues to market this product, and it advises against discontinuing Paxil during pregnancy – despite the increased risk for birth defects. To support its position on continuing Paxil use, Glaxo notes a study that indicated a 68 percent relapse rate for major depression during the course of the pregnancy among women who stopped taking Paxil while pregnant. While Glaxo points out the risk for recurrence of depression, it fails to indicate that the risk of PPHN doubles with the use of medications such as Paxil during pregnancy
If you took Paxil during pregnancy
and have a child born with birth defects or PPHN, please fill out and submit our
confidential questionnaire, or contact attorney
William Bross by email
at wlbross@hgdlawfirm.com,
or phone Heninger Garrison Davis at 1-800-241-9779.
Click here for our confidential questionnaire |