Paxil is approved for the treatment of depression and several other psychiatric disorders.
A study has identified a risk of major congenital malformations in infants born to women taking Paxil and Paxil CR during the first trimester of pregnancy. A long-term epidemiological study suggested an increase in the risk of overall major congenital malformations for Paxil (paroxetine) and Paxil CR compared to other antidepressants.
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“If you or someone you know used Paxil during pregnancy and gave birth to a child with birth defects including PPHN, please contact us for a free and confidential case evaluation.” |
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"Healthcare professionals are advised to carefully weigh the potential risks and benefits of using paroxetine therapy in women during pregnancy and to discuss these findings as well as treatment alternatives with their patients," the FDA said.
Additional research recently published in the New England Journal of Medicine shows that use of anti-depressant medications during the latter half of pregnancy increases the risk the newborn will develop a serious respiratory disorder known as Persistent Pulmonary Hypertension (PPHN). Persistent Pulmonary Hypertension (PPHN) is a serious pulmonary (respiratory) disorder that can develop in newborn babies and impairs the ability to supply oxygen-rich blood to the body. When a newborn suffers from Persistent Pulmonary Hypertension (PPHN), the pulmonary arteries (blood vessels in the lungs) fail to fully open, i.e. these arteries remain constricted. Because of this, the newborn is unable to oxygenate his/her blood. As a result, the infant cannot provide an adequate supply of oxygen-rich blood to his/her tissues and organs. Without an adequate supply of oxygen-rich blood, the infant can suffer serious complications.
Data from this study indicate that the use of Selective Serotonin Reuptake Inhibitors (SSRIs) such as Prozac®, Zoloft® and Paxil® during the second half of pregnancy may increase the risk of Persistent Pulmonary Hypertension (PPHN) by as much as six times the normal risk. Historically, Persistent Pulmonary Hypertension (PPHN) occurs in 1-2 infants per 1,000 live births. However, data from this study suggest that when Selective Serotonin Reuptake Inhibitors (SSRIs) such as Prozac®, Zoloft® and Paxil® are used by a woman during the second half of her pregnancy, the rate of Persistent Pulmonary Hypertension (PPHN) increases to 5-6 cases per 1,000 live births.
The anti-depressant drugs – known as Selective Serotonin Reuptake Inhibitors (SSRIs) include the following:
- Paxil® (paroxetine)
- Zoloft® (sertraline)
- Wellbutrin® (bupropion)
- Celexa® (citalopram)
- Cipralex® (escitalopram)
- Luvox® (fluvoxamine)
- Remeron® (mirtazapine)
- Effexor® (venlafaxine)
- Prozac® (fluoxetine)
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