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Since the first SSRI (Prozac) was approved in the United States in 1988, there has been considerable controversy over whether SSRIs, including Paxil, can cause some people to become violent and/or suicidal. In 2004, the Food and Drug Administration required Paxil and other antidepressants to carry a bold black box label warning of the increased risk of suicidal behavior in children and adolescents. Later, that warning was expanded to include adults.
In September 2005, the FDA issued a statement alerting patients and healthcare professionals to the increased risk of birth defects in babies whose mothers use Paxil while pregnant. According to the FDA advisory, women taking Paxil during the first trimester of pregnancy are one and a half to two times as likely to deliver a baby with a heart defect than women who use other antidepressants or none at all.
Less than a year later, the New England Journal of Medicine published a study linking Paxil to a rare but serious birth defect known as persistent pulmonary hypertension, or PPHN. The study findings revealed that use of Paxil at 20 weeks of pregnancy or later increased the risk of PPHN in babies sixfold.
PPHN is a serious birth defect characterized by abnormal blood flow through the heart and lungs. Even when treated promptly, the condition can have devastating effects, including heart failure, kidney failure, brain hemorrhaging and death.
Your Legal Rights
Patients have a right to know the risks associated with the drugs they’re taking. Paxil was on the market for more than a decade before the public was made fully aware of the suicide and birth defect risks.
If you or your loved one has suffered a serious Paxil side effect such as PPHN, contact an attorney today to learn more about your legal rights.
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