Paxil Birth Defects

Paxil and birth defects may be linked to side effects of Paxil when used in pregnancy.  If your child was born with birth defects and Paxil was used while pregnant, speak with an attorney to find out about the possibility of filing a Paxil lawsuit.

Recent studies and FDA warnings have identified a potential connection between the antidepressant medication Paxil and the development of severe birth defects among children exposed to the drug during pregnancy. Paxil has been available in the U.S. since 1992 when the FDA approved the medication for the treatment of major depressive disorder. In 1996, the FDA added an indication to treat obsessive-compulsive disorder and major panic disorder, in 1999 to treat social anxiety disorder, in 2000 to treat post-traumatic stress disorder, and in 2001 to treat generalized anxiety disorder. Paxil (paroxetine) is one of a group of antidepressant drugs called SSRIs, or selective serotonin reuptake inhibitors, which work by balancing the level of serotonin in the brain, a neurotransmitter responsible for controlling mood. Paxil is currently manufactured by pharmaceutical company GlaxoSmithKline.

Although Paxil is considered one of the most frequently-prescribed antidepressant drugs on the U.S. market, serious concerns have been raised about the safety of Paxil, especially in treating pregnant women and women of childbearing age. According to recent studies, women who take Paxil during pregnancy may have a significantly increased risk of giving birth to babies with one or more major Paxil side effects, namely birth defects. If you took Paxil while pregnant and your child was born with a serious birth defect or side effect, contact a Paxil lawyer to discuss your legal options. Your child may be entitled to lifetime care, which you can acquire by filing a Paxil lawsuit against GlaxoSmithKline.

Birth Defects Allegedly Linked to Paxil

An emerging body of research has identified Paxil use in pregnancy as a potential risk factor for the development of life-threatening side effects in children. Among the birth defects potentially associated with Paxil are:

  • Persistent pulmonary hypertension of the newborn (PPHN)
  • Neural tube birth defects
  • Heart defects
  • Craniosynostosis
  • Omphalocele
  • Anal atresia
  • Cleft palate
  • Cleft lip
  • Limb defects

Because a link between Paxil use in pregnancy and these birth defects may exist, the FDA has advised patients to consider all benefits and risks of Paxil treatment before prescribing the drug to women of childbearing age. Because most birth defects occur during the first trimester of pregnancy when most women are not yet aware they are pregnant, all women of childbearing age taking Paxil may be at risk of unknowingly causing irreversible harm to their unborn child such as limb defects and neural tube defects.

Paxil FDA Warnings

In 2005, the FDA issued a public health advisory warning patients and healthcare providers about the increased risk of congenital malformations, particularly heart defects, in children exposed to Paxil during the first trimester of pregnancy. This FDA decision was based on the preliminary analysis of two unpublished epidemiology studies, the first of which used Swedish national registry data, and the second of which used a United States insurance claims database. Most of the heart defects observed in these studies were atrial or ventricular septal defects, conditions characterized by a hole in the wall separating the right and left sides of the heart. In 2006, the FDA issued a second public health advisory concerning Paxil, this time warning patients and physicians about the potential connection between SSRI antidepressants like Paxil and PPHN, a life-threatening defect in which a child's circulation continues to bypass the lungs after birth, depriving the rest of the body of oxygen. This FDA warning was based on a significant study published in the New England Journal of Medicine, in which researchers found a six-times increased risk of PPHN among children exposed to an SSRI like Paxil in utero.

Paxil Use During Pregnancy

In 2005, the FDA elevated the pregnancy category of Paxil from C to D, which means there is positive human evidence illustrating the drug's potential to cause serious fetal harm when taken during pregnancy. If you are currently taking Paxil and you are pregnant or planning to become pregnant, consult your physician immediately. You should never suddenly stop taking a prescription drug without medical consent, as this may cause further harm to you or your child. With the help of your doctor, you may be able to find a safer alternative to Paxil for treating your condition.

Paxil Attorneys for Birth Defect Side Effects

The birth defects potentially associated with the antidepressant Paxil are serious and can severely alter an affected child's quality of life. If you or a loved one has suffered from a side effect or birth defect and you believe Paxil to be the cause, contact a Paxil attorney to discuss your options for legal recourse. You may be entitled to financial compensation for your injuries, medical expenses, and pain and suffering, which you can collect by filing a Paxil lawsuit against GlaxoSmithKline. You are not at fault for any injuries caused by a pharmaceutical drug. Drug companies like Glaxo are responsible for the safety of their medications, and should be held accountable for any adverse Paxil side effects sustained by consumers of their products. By hiring an experienced Paxil lawyer to represent your case, you can protect your rights and collect the compensation you deserve.

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