SSRI Litigation

Birth Defects Caused by Paxil

Doctors prescribe a wide range of different medicines to treat the symptoms of depression. These antidepressants1 change the way in which the brain functions by balancing the production of natural chemicals. Doctors prescribe antidepressants to more than 10 percent of Americans ages 12 and older.2 Doctors commonly prescribe paroxetine (brand name Paxil®, because it can effectively treat moderate to severe depression. However, there are potential side effects from the use of Paxil.

Common side effects of Paxil

Like most medicines, patients using Paxil may see a number of common side effects.3 These include:

  • Insomnia
  • Irritability and anxiety
  • Nausea
  • Sexual dysfunction
  • Headache

More serious side effects may also arise from the use of Paxil. Patients using Paxil have seen complications arise during pregnancy. Commonly, babies born to these mothers suffer facial malformations.

Birth defects caused by Paxil

Women using Paxil may see fetal malformations in their children. The risk of these malformations is higher if the mother uses Paxil in the early stages of pregnancy. Two of the most common birth defects are cleft lip and palate.4 Around half of the babies born with one of these malformations will also suffer from the other. Cleft lip or palate is one of the most common birth defects in the United States. One in 600 babies born in the country suffers from cleft lip or palate.

Causes of cleft lip or palate

A cleft lip or palate5 occurs when parts of a baby's mouth do not form properly during the first three months of pregnancy. The size and extent of the malformation can vary from one child to another. It may appear as a small notch in the child’s lip or may extend into the nose. It can also extend further into the gums. Cleft lip or palate may occur as a result of other birth defects in the body. It can also be genetic. Studies have linked the use of antidepressants such as Paxil to a higher incidence of cleft lip or palate. Children with cleft lip or palate may suffer from other development problems, including speech and language delays. This may require speech development therapy.

Government advice about Paxil for pregnant women

The U.S. Food and Drug Administration issued an alert in 2005.6 This alert warned health care professionals and consumers about the increased risk of fetal abnormalities in women using Paxil. The FDA advised doctors not to prescribe Paxil to women who are in the first three months of pregnancy or are planning pregnancy. As well as the risk of facial malformations, the FDA advised that the risk of heart defects was also higher. The FDA upgraded the drug at that time to category D, which means that studies in pregnant women have identified a risk to the unborn child.

Parents whose child suffered birth defects from the use of Paxil have successfully filed birth defect lawsuits. If you or a loved one suffers a complication after using Paxil, you should contact a birth defect lawyer for further advice.

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