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Craniosynostosis Lawsuit

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Paxil has been linked in recent studies to the development of Craniosynostosis in infants born to mothers who were administered Paxil during pregnancy.

Update: BMJ Study Links Antidepressants to Craniosynostosis

January 6, 2016 - A new study from the CDC and Boston University’s Slone Epidemiology Center has confirmed a link between the antidepressants Paxil (paroxetine) and Prozac (fluoxetine), and major birth defects. Published in the British Medical Journal (BMJ), the study found an increased risk for anencephaly, several heart defects and 2 gastrointestinal malformations in women who took Paxil during pregnancy. Prozac was linked to a heart defect and craniosynostosis, in which a baby’s skull fails to fuse properly in the womb.

Paxil Linked to Cranial Defects - Craniosynostosis

In 1992, the US Food and Drug Administration (FDA) approved the use of a new antidepressant created by GlaxoSmithKline called Paxil (generically known as paroxetine). It quickly became the most popular antidepressant on the market due to the drug’s success in treating everything from anxiety disorders to depression to phobias.

Paxil is now one of the most prescribed antidepressants in the world, with thousands of people in the United States and millions worldwide using the medication and generating $1 billion in sales annually. Up to 40,000 of these users are pregnant women, according to the American Medical Association.

Paxil is classified as a Selective Serotonin Reuptake Inhibitor (SSRI), working by allowing the serotonin levels in the brain to increase, improving the user’s mood, appetite, memory, and sleep behavior. Unfortunately, Paxil, as well as many other SSRI’s, have been found to cross the placenta and affect the fetus while still in the womb. This increases the risk of the baby being born with a congenital defect. Studies have found that if Paxil is taken during the first three months of pregnancy, the risk of the child being born with a congenital defect is up to 6 times more likely.

One of the congenital defects that has the medical community alarmed is the increased risk of craniosynostosis in the newborn infants. Craniosynostosis, also called cloverleaf skull, is a cranial defect in which some or all of the cranial sutures close too early, a problem leading to impared brain growth and skull deformity. In the normal skull of a newborn, the sutures are open and the bones of the skull are flexible, allowing room for growth, slowly fusing together as the baby ages. In addition to skull deformity, craniosynostosis can also cause increased pressure inside the skull resulting in further damage to the brain.

In most cases, surgery is needed to separate the bones as well as to reshape the skull. Without this treatment, mental retardation and blindness is the frequent outcome. Infants should be treated as soon as the condition is diagnosed, to prevent further harm from occurring. Craniosynostosis is normally diagnosed within the first few months of life when a cranial deformity is noticed.

Studies have concluded that craniosynostosis, as well as other pre-birth side effects, are a very serious risk when taking Paxil and other SSRI’s during pregnancy. As a result, many organizations are now warning women against taking Paxil if they are pregnant or planning to become pregnant. In September of 2005, GlaxoSmithKline changed the warning label for Paxil to reflect the increased risk of birth defects and the US Food and Drug Administration (FDA) upgraded Paxil’s drug category to Category D, indicating that the drug has been found to cause harm to human fetuses.

Experts estimate that hundreds of babies have been born with Paxil-related birth defects, with healthcare professionals and mothers unaware of the risks that Paxil poses to the unborn child. The fact that Paxil can be extremely difficult to stop due to severe withdrawal symptoms adds to the difficulty women face if they become pregnant while taking the drug. It is important that every consumer and healthcare professional be aware of the risks to be able to choose a proper course of action. Many young lives depend on making the correct choice.

Learn More About Craniosynostosis: National Institute of Nerological Disorders and Stroke | Children's Hospital of Wisconsin | U.S. National Institutes of Health MedlinePlus | John Hopkins University School of Medicine

More Defects Linked to Antidepressants

In addition to craniosynostosis, a large number of birth defects have been associated with the use of antidepressants including: