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GlaxoSmithKline’s Paxil and Related Birth Defects

Since the FDA issued a public health advisory in 2005 concerning the birth defect risks associated with Paxil, serious concerns have been raised about the safety of GlaxoSmithKline’s antidepressant drug. Paxil initially garnered FDA approval in 1992 and has since been commonly prescribed to patients suffering from major depressive disorder. In the following years, Paxil …

Since the FDA issued a public health advisory in 2005 concerning the birth defect risks associated with Paxil, serious concerns have been raised about the safety of GlaxoSmithKline’s antidepressant drug. Paxil initially garnered FDA approval in 1992 and has since been commonly prescribed to patients suffering from major depressive disorder. In the following years, Paxil was additionally indicated as a treatment for conditions like major panic disorder, obsessive-compulsive disorder, post-traumatic stress disorder, generalized anxiety disorder and social anxiety disorder. As the pregnancy risks associated with Paxil have come to light, Paxil attorneys across the country have investigated claims filed by parents who believe their children have been affected by the antidepressant drug. If you took Paxil while pregnant and your child was born with a serious birth defect, contact a qualified Paxil attorney today.

Paxil Pregnancy Risks

In 2005, the FDA released a warning to consumers and healthcare providers regarding the increased risk of congenital birth defects associated with exposure to Paxil (paroxetine) in the first trimester of pregnancy. In light of this birth defect risk, the FDA elevated the pregnancy category of Paxil from C to D and added new data and recommendations to the Warnings section of Paxil’s prescribing information. One year later, the FDA issued a second public health advisory, this time warning the public about the link between SSRI antidepressant drugs like Paxil and the birth defect PPHN (persistent pulmonary hypertension of the newborn).

Birth Defects Allegedly Linked to Paxil

The most revealing Paxil birth defect study was published in the New England Journal of Medicine in 2006, in which researchers found a six-times increased risk of PPHN among children exposed to Paxil and other SSRIs late in pregnancy, compared to children not exposed to any antidepressants in pregnancy. Persistent pulmonary hypertension of the newborn is a serious heart and lung defect in which a baby’s circulation continues to bypass the lungs after birth. Even though the baby can breathe, oxygen in the breathed air will never reach the bloodstream to be delivered to the rest of the body. According to the FDA, approximately one to two babies in every 1,000 develop PPHN shortly after birth. According to researchers involved in this study, up to twelve out of 1,000 babies exposed to an SSRI after the twentieth week of pregnancy were born with PPHN.

Paxil Attorneys Can Help

It is the duty of pharmaceutical companies and the FDA to keep consumers informed about the dangers of prescription and over-the-counter medications, especially those with the potential to cause birth defects in babies. Unfortunately, some drug firms intentionally conceal the side effects of their medications in an attempt to avoid negative consequences, like a drug recall. If you or a loved one has suffered from a birth defect which you believe to be linked to the SSRI antidepressant Paxil, contact a Paxil attorney for legal help. With an experienced Paxil lawyer on your side, you can protect your family from further harm and hold the allegedly negligent drug company liable for its dangerous product.

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